cyrilzakka/clinical-trials huggingface dataset:
Hyaluronan-enriched Medium and Euploid Blastocyst Transfers

It has been proposed that enriching transfer media with hyaluronan (EmbryoGlue medium) improves pregnancy outcomes compared with media containing lower concentrations of this molecule. However, none of previous studies included preimplantation genetic testing for aneuploidy (PGT-A) embryos. In order to investigate the impact of this hyaluronan-enriched on pregnancy outcomes, it is essential to evaluate its efficacy on euploid-only embryo transfers. The aim of the present study is to evaluate whether a short period of exposure of euploid blastocysts to EmbryoGlue prior to and during transfer positively impact on pregnancy outcomes of frozen embryo transfer (FET) cycles.

The study period will be determined by the completion of the predetermined sample size, with two interim analyses planned when 35% (n=274) and 70% (n=548) of the target sample size is achieved to calculate conditional power. If conditional power is estimated to be lower than 15% at first interim analysis or lower than 30% in the second interim analysis, the trial will be stopped due to futility. The study will be performed in Abu Dhabi-Fertility clinic. During the period of this prospective study, euploid blastocysts of enough quality that have been biopsied only on Day-5 for PGT-A, will be warmed for single blastocyst transfer. The patient´s endometrial preparation protocol for FET will be restricted to HRT only. The study will be double-blinded (blinded to patient and doctor performing transfer).

Eligibility Criteria:
Inclusion Criteria:

* All frozen embryo transfer (FET) cycles with euploid blastocysts biopsied and vitrified on Day 5 after PGT-A.
* Rank of randomization based on embryo quality.
* Only hormonal replacement theraphy (HRT) cycle regimen.
* Women aged 18 years to 46 years.
* Having at least 1 chromosomally normal vitrified blastocyst(s) on Day 5 available for transfer.
* All sperm samples.
* BMI between 18 and 35.

Exclusion Criteria:

* FET cycles with preimplantation genetic testing for monogenic disorders (PGT-M) and for structural rearrangements (PGT-SR).
* FET cycles with mosaic / aneuploid blastocysts.
* FET cycles with unknown outcome.
* FET cycles with Day 6 or Day 7 biopsied blastocysts.
* FET with patients' endometrium preparation with treatments other than HRT.
* FET where PGT-A was performed for gender selection.
Using a Patient-Centered mHealth Intervention to Improve Adherence to Oral Anticancer Medications

This study is being done to determine if sending reminder text messages helps patients take their Oral Anticancer Medication (OAMs) when they are supposed to.


Eligibility Criteria:
Inclusion Criteria:

* Patient in the Sarcoma, Solid Tumor Gastrointestinal (ST GI), and Thoracic Medicine service at MSK.
* Starting a new treatment regimen that includes a single oral anticancer medication
* Patients must have a mobile phone that can send and receive SMS/MMS messages and is internet-enabled.
* Age 18 or older.
* Ability to speak and read English because we do not have the resources to translate the text messages into other languages.

Exclusion Criteria:

* Patient expresses inability or unfamiliarity with using SMS/MMS messaging on their phone and is unwilling to be trained in the use of this technology.
A Randomized Study to Compare a Hydrogel Packing System to Standard Packing During HDR Brachytherapy for Cervical Cancer

In this study, a new, low cost packing system ("BrachyGel VHPS") is being tested as a packing option during brachytherapy along with standard options to make sure that it keeps the unrelated organs away from radiation at least as well as the standard options, and to better understand the safety and patient discomfort associated with BrachyGel VHPS and the standard packing options.

As part of vaginal brachytherapy, the organs that do not need to receive radiation (unrelated organs) are moved out of the way of the radiation with a "packing system". The usual low cost and available standard of care packing systems to move these unrelated organs out of the way can sometimes be uncomfortable for the patient, may not move all of the unrelated organs all the way out of the radiation's path, and rely on the doctor to place them correctly.

If you participate, you will receive 5 fractions of brachytherapy according to standard clinical care. For three of the fractions, a standard packing option will be used and for two of them BrachyGel VHPS will be used. For the first fraction both groups will have the same packing option but participants will be randomized to either have BrachyGel during fractions 2 and 4 or during fractions 3 and 5. You'll be asked to complete a questionnaire after fractions 2-5 to get your feedback on any discomfort you have during or after brachytherapy from the packing system.

Eligibility Criteria:
Inclusion Criteria:

1. Biopsy showing cancer of the cervix (squamous cell carcinoma, adenocarcinoma, adenosquamous, neuroendocrine, etc)
2. FIGO IB1 - IVB Staging according to FIGO and TNM guidelines
3. Planning to receive brachytherapy as a part of the definitive treatment for cervical cancer
4. Karnofsky performance status (KPS) ≥ 70 or ECOG status ≤1
5. Stated willingness to comply with all study procedures and availability for the duration of the study
6. Age ≥ 18 years
7. Agreement to adhere to Lifestyle Considerations throughout study duration

Exclusion Criteria:

1. History of pelvis or abdominal radiation therapy (RT) that is not a part of the definitive treatment plan for the cancer of interest"
2. History of total or partial hysterectomy
3. Plan to receive external beam RT (EBRT) alone as the definitive treatment plan for the cancer of interest
4. Known pregnancy or lactation (no pregnancy test required prior to participation)
5. Known contraindications to brachytherapy
Assistance Program for Outpatients Following an Allogeneic Hematopoietic Stem-cell Transplant

After the initial monitoring period during hospitalization and isolation, patients with recent transplants are regularly monitored in monthly consultations but are still fragile, immunosuppressed and undergoing many treatments. The implementation of an outpatient assistance program for transplant patients should be feasible and allow for the improvement in medical-psycho-social care for the patients during this fragile and risky period, improve the satisfaction and quality of life for these transplant patients and assist in their socio-professional and familial reintegration.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients over 18 years of age
* Having received an allogeneic hematopoietic stem-cell transplant
* In full remission
* Outpatients
* Having given their informed consent for the participation in the outpatient assistance program with a navigation nurse (AMA-ALLO) at the first post-transplant consultation (starting on Day 100 +/- 10 days post-transplant i.e., when the patient passes the initial post-transplant monitoring period in hospitalization (conventional or by day) to the monitoring period in monthly medical consultations) and continuing for 12 months
* Affiliated with the social security system

Exclusion Criteria:

* Transplant patients not having given their informed consent for inclusion in AMA-ALLO
* Hospitalized or non-outpatient transplant patients
* Post-transplant patients in cytological relapse
* Patients under a legal regime of adult protection (guardianship, curatorship, etc.)
Airway Pressure During Nasal High Flow and CPAP in Neonates

Nasal High Flow (NHF) and CPAP are established forms of respiratory support in neonates and often produce similar clinical outcomes. The aim of the study was to investigate airway pressure during NHF and CPAP in neonates.

Methods: A physiological study which measured pressure intra-nasally with micro (750 µm) pressure probes (Millar, USA) in 10 (5M / 5F) healthy newborns with mean gestation age 37.18 (SD 1.29) wk and mean birth weight of 2414 (SD 503.13) g. NHF was applied at 8 L/min (AIRVO 2) through smaller (OPT 314) and larger (OPT 316) Optiflow nasal cannula; CPAP 5 cmH20 was produced by a Bubble CPAP system and nasal mask interface at constant flow 8 L/min (Fisher \& Paykel Healthcare, NZ). Values are expressed in cmH20 as means and standard deviations (SD).

Eligibility Criteria:
Inclusion Criteria:

* Healthy term newborns

Exclusion Criteria:

* Newborns with any medical problems after birth
* Absent of parents consents
Radiolabeled Glass Beads Used for Treating Patients With Primary Liver Cancer When Surgery is Not an Option

Fewer than 15% of hepatoma patients are suitable candidates for surgical removal of their cancer. The purpose of this protocol is to provide supervised access at Oregon Health and Science University to Y-90 treatment to provide these patients access to an alternate therapy. The radioactive beads are placed directly near or into the liver tumor with the intention of destroying the tumor cells.

Patients receive Y-90 (yttrium) glass microspheres via percutaneous hepatic arterial infusion. Patients amy be retreated between 30-90 days after initial infusion. After completion of therapy, patients are followed for 30 days and then every 3 months for up to 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of HCC
* Cancer is unresectable
* ECOG Score 0-2
* Age of 18 yrs or over
* Able to give consent

Exclusion Criteria:

* Contraindication to angiography and selective visceral catheterization
* Portal hypertension with portal venous shunt away from the liver
* Evidence of potential delivery of \> 16.5 mCi of radiation to the lungs
* Evidence of any detectable Tc-99m MAA flow to the stomach or duodenum, after application of established angiographic techniques to stop such flow
* Significant extrahepatic disease representing an imminent life-threatening outcome
* Severe liver dysfunction or pulmonary insufficiency
* Active uncontrolled infection
* Significant underlying medical or psychiatric illness
* Pregnancy
Sacroiliac Orthopedic Blocking and Cervical Spine Function

This study seeks to determine if the correction of a sacroiliac lesion can produce a functional change in cervical spine. Reduction of a sacroiliac joint lesion may alter cervical spine function.


Eligibility Criteria:
Inclusion Criteria:

* Young adults currently enrolled at Logan College

Exclusion Criteria:

* Recent cervical spine injuries or surgeries
* Surgical hardware in the cervical spine or pelvis
* Any cervical condition that would make ROM \& strength testing painful.
18F-FDG PET/CT-based Prognostic Model for Predicting Outcome in Patients With Natural Killer/T-cell Lymphoma

The purpose of this study is to evaluate whether 18F-FDG PET/CT-based prognostic model of NK/T-cell lymphoma can predict disease progression

In this study investigators develop a prognostic model based on 18F-FDG PET/CT and test its ability for prognostic value in patients with DLBCL. PET/ CT scans evaluation using the liver SUVmax as reference. Positive lesions in PET were indicated as SUVmax of residues higher than the threshold or new 18F-FDG avid lesions. 18F-FDG PET/CT-based prognostic model includes PET/CT image, dominant clinical and pathological prognostic factors to predicting disease progression during chemotherapy or survival in NK/T-cell lymphoma.

Eligibility Criteria:
Inclusion Criteria:

* newly diagnosed NK/T-cell lymphoma
* treated using an anthracycline-containing regimen
* minimal follow-up at 6 months after the completion of first-line treatment
* complete medical history and clinicopathological data

Exclusion Criteria:

* secondary malignant disease
* serious infection or inflammation (e.g., HIV)
* primary central nervous system lymphoma
* hepatic or renal dysfunction.
This is a Study to Evaluate the Pharmacokinetics and Safety of IBI362 in Chinese Adolescents With Obesity

The study is a first-in-pediatric assessment of the safety, tolerability, and pharmacokinetic characteristics of multiple doses of IBI362 in Chinese adolescent subjects with obesity. It employs a multicenter, randomized, double-blind, and placebo-controlled trial design. The study plans to enroll 36 adolescents (aged ≥12 years and \<18 years) with obesity who have experienced less than a 5% decrease in Body Mass Index (BMI) after at least 12 weeks of diet and exercise control.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects who are aged ≥12 years and \<18 years at the time of signing the informed consent;
2. At screening, the Body Mass Index (BMI) meets the obesity criteria according to "WS/T586-2018 Screening Criteria for Overweight and Obesity in School-age Children and Adolescents";
3. Subjects who have maintained a controlled diet and exercise for at least 12 weeks prior to screening, with no more than a 5% decrease in BMI (as reported by the subject, parent, or legal guardian);
4. Able to maintain a stable diet and exercise lifestyle during the study period;
5. Capable of understanding the procedures and methods of this study, willing to strictly adhere to the clinical trial protocol to complete this trial, with both the subject and the parent or legal guardian voluntarily signing the informed consent form.

Exclusion Criteria:

1. Prepubertal subjects (Tanner Stage I)
2. Subjects for whom the investigator suspects an allergy to the study drug or any of its components, or subjects with a history of allergies
3. Use of other weight-loss medications or treatments prior to screening
4. Evidence or history of other medical conditions prior to screening:

   * HbA1c ≥ 6.5% at screening or a previous diagnosis of Type 1 or Type 2 diabetes
   * Presence of retinopathy at screening
   * History of severe hypoglycemia or recurrent symptomatic hypoglycemia
   * Obesity secondary to disease or medication, including hypercortisolism (e.g., Cushing's syndrome)
   * Previous bariatric surgery
   * History of moderate to severe depression; or history of serious psychiatric illness
   * Previous suicidal ideation or suicide attempt
Early Aggressive Versus Initially Conservative Therapy in Elderly Patients With Non-ST-Elevation Acute Coronary Syndrome

A randomized study comparing an early aggressive with an initially conservative strategy in patients \>74 y.o. with non-ST-elevation acute coronary syndrome.

This study had generated a secondary one:

"Causes of death in elderly patients with Non-ST-Elevation Acute Coronary Syndrome; predictors of in-hospital and follow-up death"

Patients \>74 y.o. with non-ST-elevation acute coronary syndrome will be randomised to an early aggressive (coronary angiography within 72 hours followed, when indicated, by revascularization) or an initially conservative strategy (medical therapy, and coronary angiography only for refractory ischemia).

As reported in Amendment 1, the trial was stopped in May 2010 after the enrolment of 313 patients, which was the minimum sample size calculated in order to achieve a 80% power of detecting a difference in the primary-endpoint rate from 40% in the conservative arm to 25% in the invasive arm, based upon the log-rank test for survival curves (1-beta 0.80; 2-tailed alpha 0.05)

Eligibility Criteria:
Inclusion Criteria:

* Over 74 years of age.
* Have had symptoms suggestive of acute myocardial ischemia at rest within 48 hours prior to randomization, and ischemic ECG changes or elevated levels of biochemical markers of myocardial damage.
* Provide written informed consent before randomization.

Exclusion Criteria:

* Secondary causes of acute myocardial ischemia.
* Ongoing myocardial ischemia despite maximally titrated anti-ischemic therapy (invasive strategy recommended).
* Ongoing signs of acute heart failure despite treatment (invasive strategy recommended).
* Percutaneous coronary intervention or bypass surgery within 30 days prior to randomization.
* A serum creatinine level greater than 2.5 mg/dL.
* Active internal bleeding, history of hemorrhagic diathesis or recent transfusion of red blood cells, whole blood or platelets.
* History of cerebrovascular accident within the previous month.
* Known current platelet count \< 90,000 cells/mL.
* Gastrointestinal or genitourinary bleeding of clinical significance within 6 weeks prior to randomization.
* Concomitant severe obstructive lung disease, malignancy or neurologic deficit limiting follow-up or adherence to the study protocol.
* Participation in any phase of another clinical research study involving the evaluation of another investigational drug or device within 30 days prior to randomization.
* Inability to give at least verbal informed consent to the study.
Attention Control Training for PTSD in Children

Participants will complete a pre and post training psychological assessment. Participants will be assigned to attention control training or the comparison stimuli computer task in a double-blind randomized control trial design. Both computerized dot probe tasks display two faces on a computer screen, one above the other, followed by a small right or left arrow appearing in the location vacated by one of the faces. Participants are required to respond as quickly as they can by pressing the indicated right or left arrow on their computer keyboard without compromising accuracy. Participants complete 6 training sessions.


Eligibility Criteria:
Inclusion Criteria:

* significant symptoms of PTSD and qualifying traumatic event

Exclusion Criteria:

* new traumatic event within one month of beginning the trial
Glutathione Metabolism in Adolescents With Type 1 Diabetes - Study A

Glutathione is normally present at high (millimolar) levels in blood and plays an important role in the body's defense against oxidative stress, that is, against the damage caused to the body by reactive oxygen species produced by the metabolism of most nutrients, including glucose. Glutathione is a small peptide made from 3 amino acids, glutamate, cysteine, and glycine.

This study is looking at how blood sugar levels may affect the way glutathione is made and used by the body. Since glutathione is continuously synthesized and broken down, the amount of glutathione present in blood depends on the balance between its rate of synthesis and its rate of use.

In earlier studies, the investigators found that in poorly controlled diabetic teenagers, glutathione was low, not because its production was decreased, but because it was used at an excessive rate. In this study, the investigators want to determine how short-term changes in blood sugar levels affect glutathione levels. This will help improve our understanding of how diabetes affects metabolism.

Adolescents with uncomplicated T1D will receive two, 5-hour infusions of deuterium-labeled cysteine on 2 separate days, a few weeks apart, while blood glucose will be maintained, using intravenous insulin infusion:

* in the hyper-glycemic range (200-250 mg/dL) on one study day, and
* near normoglycemia (80-140 mg/dL) on the other study day.

The order of the study days will be randomized.

We will determine whether the level of blood glucose at the time of study affects blood glutathione concentration, and, if so, whether this is associated with changes in the fractional rate of glutathione synthesis, as determined from the incorporation of labeled cysteine into blood glutathione over the course of the 5-hr infusion of labeled cysteine.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes, using usual criteria such as: glycosuria, hyperglycemia prior to treatment
* BMI \<25 kg/m2
* Age 14-18
* HbA1c\>7.5%
* No evidence of diabetic complications
* Written informed consent from parents or legal guardian, and assent from patient

Exclusion Criteria:

* Presence of significant anemia (hemoglobin \<11g/dL)
* Presence of intercurrent illness such as infection
* Presence of chronic disease such as other endocrine deficiency, chronic respiratory or cardiac disease
* Chronic use of medication other than insulin
* Use of vitamin or mineral supplements within 2 weeks of study
Interdisciplinary + Intersectoral Telemedicine Evaluation, Coordination + Treatment in RhineMain+ Parkinson's Network

Project objective: To improve the health care of Parkinson's disease patients in the ParkinsonNetz RheinMain+.

Hypothesis: Through the interdisciplinary and cross- sectoral networking in a tele medical network and the coordinating function of an "advanced practice nurse" (APN) specially trained for Parkinson's disease, the process quality within the network is increased and the individual health status is positively influenced.

To effectively influence the long-term course of Parkinson´s a synergistic application of an individualized therapy program, which is tailored specifically to the symptoms and disease stages, is needed. The central element of the new form of care is the implementation of a tele medical evaluation and coordination function, which controls individualized treatment processes within the network. The individualized evaluation and coordination of treatment paths is carried out within the already existing Parkinson's network RheinMain+ by a non-physician medical specialist (APN) specially trained for the indication Parkinson's disease. In-depth assessments of the individual disease situation of the patients will take place. Based on these assessments, an evidence-based and patient-centered treatment and care plan is developed. The treatment plans are monitored, controlled and evaluated by the APNs using audiovisual or tele medical communication. In addition, APNs are empowered to initiate treatment interventions necessary to implement clinical guidelines and standards, and to take charge of these interventions as part of delegation processes. The APNs ensure that patients are cared for in accordance with needs and guidelines in all areas of care. To this end, they offer, among other things, training in the handling of patients with Parkinson's disease for other professional groups involved in the treatment process and not only have the patients in mind, but also include relatives and the supporting team.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of primary Parkinson's syndrome (G20.-) or atypical Parkinson's syndrome (G23.-, according to the current diagnostic criteria of the Movement Disorder Society, including the criteria of at least bradykinesia and rigidity or resting tremor must be present)
* In the care regions of Hesse and Rhineland-Palatinate
* Ability to give consent present

Exclusion Criteria:

- Severe dementia

* Severe depression
* Psychoses or other psychiatric or medical comorbidities that could affect the smooth implementation of the study protocol (e.g.

tumor disease with limited life expectancy, need for dialysis, etc.)

* Drug or alcohol addiction
* Women who are pregnant or breastfeeding
* Simultaneous participation in another interventional treatment study
* Illiteracy or insufficient language skills
Validation of Phase Lag Entropy(PLE) as an Indicator of Depth of Sedation in Patients Undergoing Spinal Anesthesia

For verifying the phase lag entropy as the tool for measurement of level of consciousness, the investigators compared phase lag entropy to bispectral index. Using Target-Controlled Infusion pump, propofol was infused for sedation during the spinal anesthesia. The investigators measured Observer's Assessment of Alertness/Sedation Scale as the propofol concentration rises. At the same time, The investigators observed phase lag entropy score and bispectral index score.


Eligibility Criteria:
Inclusion Criteria:

* patients who require sedation during the spinal anesthesia

Exclusion Criteria:

* dementia, CVA patients, patients have problems with communication