cyrilzakka/clinical-trials huggingface dataset:
Oral Intake During Labor

A randomized clinical trial (RCT) to evaluate the impact of unrestricted low fat, low residue oral intake during labor on maternal and neonatal outcomes as well as maternal satisfaction.

This study is a quantitative, randomized experimental design study to determine the impact of unrestricted low fat, low residue oral intake during labor on the indicated outcome variables and patient satisfaction. The comparison group will continue standard care of being allowed a clear liquid during active labor (≥6cm dilation), while the experimental group would be allowed to self-regulate oral intake with a low fat, low residue diet during active labor.

Eligibility Criteria:
Inclusion Criteria:

* Active Duty and Department of Defense (DoD) beneficiary Pregnant women 18 years of age and older
* 37 weeks gestation or greater at time of admission
* singleton fetus
* cephalic presentation
* who plan to labor/deliver at DGMC (military beneficiaries).

Exclusion Criteria:

* Morbid/severe obesity (pre-pregnancy BMI ≥40 kg/m2
* diabetes
* hypertension (to include pre-eclampsia or eclampsia)
* previous cesarean section
* uncontrolled gastroesophageal reflux disease (GERD) (symptomatic with medication)
* past history or current diagnosis of hyperemesis gravidarum
* food allergies to any items contained in the gastric/soft bland diet
* patients utilizing nitrous oxide for labor analgesia (should this treatment be available at DGMC)
* Difficult airway as defined by the anesthesia staff.
* Mallampati score 3 or 4
* Thyroid mental distance less than 7 cm or 3 finger breaths
* Mouth opening less than 3 finger breaths
* Short thick neck, Micrognathia
* Further indications as determined by the anesthesia provider doing the anesthesia preoperative assessment (pregnancy in and of itself will not be considered a disqualification due to airway changes during labor)" in order to define difficult airway per anesthesia.
* Under age 18
* Additional clinical risk factors as determined by the care provider
Educational TOolS for Pregnant Women With Diabetes Mellitus.

A randomized controlled trial evaluating whether a patient-centered virtual educational tool based on small videos focusing on optimization of mental health, diet, physical activity, self-adjustment of insulin dose and use of diabetes technology in addition to usual individual face-to-face education, will improve glycemic control and pregnancy outcome ij women with pre-existing diabetes mellitus compared to women receiving usual individual face-to-face education alone.

ETOS-DM is a national RCT evaluating the effect of combined virtual patient-centered education based on a tool of small videos accessible via smartphones in addition to usual individual face-to-face education during pregnancy or to routine individual face-to-face education only.

The small educational videos covering topics as food choices, physical activity, self-adjustment of insulin dose insulin pump settings during pregnancy, use of CGM during pregnancy, mental health among others,each of 1-4 minutes duration, will be developed in collaboration with user representatives (women with pre-existing diabetes who are or have recently been pregnant) and relevant health care professionals.

. The inclusion period of the ETOS-DM study starts on September 1st 2023 and ends on August 31st 2025.

Pregnant women with pre-existing diabetes will be randomized before 14 gestational weeks. The women in the intervention group will have free, unlimited access to approximately 10 educational videos. The use of these virtual educational videos will be monitored and the women's own experience with the videos will be explored. The women will be followed during pregnancy, delivery until one month after delivery. Both groups of women follow usual local care and local face-to-face education which is allowed to change during the study period.

Stratification will be performed for diabetes center, for diabetes type and, in women with type 1 diabetes, use of MDI or insulin pump.

Eligibility Criteria:
Inclusion Criteria:

* Women, age ≥ 18 years
* Type 1 diabetes, type 2 diabetes or other types of pre-existing diabetes (e.g., maturity onset diabetes of the young (MODY))
* Pregnant with one or more intrauterine singleton living foetus(es) (5 to 13 completed gestational weeks) at inclusion confirmed by an ultrasound scan)

Exclusion Criteria:

* A diagnosis with severe mental or psychiatric barriers or a concurrent disease based on the decision of the investigator
* No proficiency in Danish to understand oral and written information

To secure independent observations, women can be randomized in the ETOS-DM study only once.
Comparative Evaluation of IRM and Autopsy in the Evaluation of Intra Uterine Fetal Death

Fetal intra uterine death is a rare event (incidence 2/1000 births) , unexpected and psychologically painful for the couple and the healthcare team. In this difficult context, it is essential to understand the etiology of death to guide the management of subsequent pregnancies. Among the investigations, foetopathologic examination is essential, but the examination of the brain is not possible in more than half of the cases due to the cerebral maceration due to the incompressible delay between death and expulsion.

The use of MRI as a diagnostic tool fetal post- mortem " virtual autopsy " performed before expulsion of the fetus is interesting because it would permit to obtain a macroscopic examination of the fetal brain, archivable, and a gain concerning the diagnosis. Thus, a normal MRI will exclude cerebral anatomical abnormality , stroke or bleeding . If MRI abnormalities are found , it will not only guide the foetopathologic review, but mainly to guide the etiology . On the other hand , it is a non-invasive tool and acceptability by the couple would be better than autopsy which is often refused by the couple in this difficult psychological context.

In this study , MRI will be given in addition to conventional autopsy in the painful waiting time between the time of diagnosis of death and expulsion without delaying care . If this study is validated , MRI may be systematically proposed in this indication or alternative to autopsy when it will be refused by the parents.


Eligibility Criteria:
Inclusion Criteria:

* Patient for which he was diagnosed with intra uterine death confirmed by ultrasound
* Mono fetal pregnancy,
* Term: 24 to 42 weeks' gestation
* Age\> 18 years
* Patient having readen the letter of information and signed the consent.

Exclusion Criteria:

* Contraindication to MRI (heart valve, pacemaker, neurosurgical clips, claustrophobia, intraocular metallic foreign bodies)
* Maternal complications: bleeding during, eclampsia, placental hematoma retro, imminent work
* Twin pregnancy
* Patient under guardianship or trusteeship
* Patient not speaking and writing French
A Study of PARG Inhibitor IDE161 in Participants With Advanced Solid Tumors

The purpose of this study is to characterize the safety, tolerability, and efficacy of IDE161 as a single agent and in combination with pembrolizumab.

The purpose of this study is to characterize the safety, tolerability including determination of maximum tolerated dose (MTD), maximum accepted dose (MAD), recommended dose(s) for expansion (RDE) and/or recommended Phase 2 dose (RP2D), pharmacokinetics (PK), pharmacodynamics (PD) and preliminary anti-tumor activity of IDE161 as a single agent in participants with advanced or metastatic solid tumors harboring BRCA1/2 loss of function alterations and/or other defects in the homologous recombination (HR) pathway and in combination with pembrolizumab in participants with advanced/recurrent endometrial cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Adult participants must be 18 years of age or older
2. Advanced or metastatic solid tumors excluding primary central nervous system (CNS) tumors
3. For Module 1 only, Have documented evidence of BRCA1/2 and/or genetic alterations conferring homologous recombination deficiency (HRD) (ATM, BARD1, BRIP1, CDK12, CHEK1, CHEK2, FANCL, PALB2, PPP2R2A, RAD51B, RAD51C, RAD51D, RAD54L, NBN, FANCA)

   For Module 2 only, results of MSI and/or MMR testing required.

   For Module 2 only, results of BRCA1/2 and HRD gene testing required.
4. Participant must have progressed on at least one prior line of therapy in the advanced or metastatic setting that is considered an appropriate standard of care, or for which the participant has documented intolerance
5. For Module 2 only, advanced or metastatic Endometrial Cancer (uterine carcinosarcoma is excluded)
6. For Module 2 only, Must have progressed on treatment with an anti-PD-1/L1 monoclonal antibody (MAB)

Exclusion Criteria:

1. Known primary CNS malignancy
2. Impairment of GI function or GI disease that may significantly alter the absorption of IDE161
3. Have active, uncontrolled infection
4. Clinically significant cardiac abnormalities
5. Major surgery within 4 weeks prior to enrollment
6. Radiation therapy within 2 weeks prior to enrollment
7. Systemic cytotoxic chemotherapy within 4 weeks prior to enrollment
8. Radioimmunotherapy within 6 weeks of enrollment
9. Treatment with a therapeutic antibody within 4 weeks prior to enrollment
10. Treatment with an anti-cancer small molecule within 5 half-lives (t1/2), or 2 weeks, whichever is shorter
11. Have current active liver or biliary disease
12. For Module 2 only, History or allogeneic tissue/solid organ transplant
13. For Module 2 only, Active autoimmune disease that has required systemic treatment in past 2 years
14. For Module 2 only, History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
Dasatinib in Newly Diagnosed Chronic-Phase Chronic Myeloid Leukemia in Japan

The purpose of this study is to evaluate effectiveness of Dasatinib as the first line therapy for patients with newly diagnosed chronic myeloid leukemia in chronic phase in Japan.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed Chronic Myeloid Leukemia in the Chronic Phase
* 20 years old over
* ECOG performance status (PS) score 0-2
* Adequate organ function (hepatic, renal and lung)
* Signed written informed consent

Exclusion Criteria:

* A case with the double cancer of the activity
* Women who are pregnant or breastfeeding
* The case of Pleural effusion clearly
* Patients with complications or a history of severe or uncontrolled cardiovascular failure following

  * have a Myocardial infarction whithin 6 months
  * have an Angina within 3 months
  * have a Congestive heart failure within 3 months
  * have a QTc interval of more than 450msec at baseline
* A serious uncontrolled medical disorder that would impair the ability of the subjects to receive protocol therapy
Study of OT-551 Eye Drops to Prevent or Delay Progression of Nuclear Cataracts Following Vitreous Removal

The purpose of this trial is to compare the ability of two doses of OT-551 ophthalmic solution and drug-free solution to safely and effectively prevent or delay the progression of nuclear cataracts that frequently develop as a result of vitrectomy (surgery for retina repair), thereby avoiding the need for a second surgery (cataract removal). Victrectomies involve removal of the jelly-like substance (vitreous) that is located in a cavity behind the lens.


Eligibility Criteria:
Inclusion Criteria:

* Imminent vitrectomy to repair macular holes or puckers
* Ability to be screened for eligibility and begin dosing 7-10 days in advance of the surgery
* Best corrected ETDRS visual acuity equivalent to Snellen 20/400 or better in the surgical eye and 20/100 or better in the fellow eye

Exclusion Criteria:

* Artificial lens or no lens in the surgical eye
* Cataract (greater than slight opacity or thickness) in the surgical eye
* Any other retinal abnormality which may be vision-threatening
* Serious heart, kidney, or liver disease
* Recent ophthalmic surgery (within 6 months) or ocular infection (within 30 days)
* Poorly controlled diabetes or unstable glaucoma
Comparison of Upper Extremity Functional Performance in Hemophilic and Healthy Children

The goal of this observational study is to evaluate the functional performance of the upper extremity joints (scapula, shoulder, elbow, and wrist) in haemophilic children and compare muscle strength and ADL limitations with healthy children.

This study aims to evaluate the upper extremity functional performance, muscle strength, and daily living activity levels of hemophilic children and compare them with healthy children. The goal is to determine the effects of hemophilia on these children and contribute to the development of appropriate rehabilitation strategies. Parameters include explosive strength, isometric muscle strength, wrist grip strength, and functional exercise capacity. Additionally, the ADL-Glittre pediatric version test and Hemophilia Joint Health Score (HJHS) will be used to assess joint health and GYA performance. Muscle strength is crucial for hemophilic children to perform daily activities, and the relationship between muscle strength and GYA levels will be investigated. The project aims to guide the development of physiotherapy and rehabilitation strategies for hemophilic children and contribute to the literature by filling existing gaps, ultimately creating an important reference for healthcare professionals and families.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Hemophilia A or B
* Receiving prophylaxis treatment (a routine treatment)
* Negative for inhibitors at the time of enrollment

Exclusion Criteria:

* Positive for inhibitors at the time of enrollment
* Acute elbow bleeding
* History of acute muscle bleeding
* History of surgery in any upper extremity joints
* Having undergone radionuclide synovectomy
Phase II Clinical Trial of Intraoral Grafting of Human Tissue Engineered Oral Mucosa

The purpose of this study is to improve the current standard of care of repairing mouth soft tissue defects.

This study will test a tissue equivalent ex vivo produced oral mucosa equivalent(EVPOME), which is a subject's own cells grown on top of a piece of AlloDerm (a commercially available freeze dried human cadaver tissue that is routinely used in present day surgical reconstructive procedures) to create a new piece of soft tissue for use only in that subject's body. The tissue equivalent product will be tested against a non-experimental method of grafts, the gold standard a piece of palatal oral mucosa (POM) to see which works best. Each subject will be randomly assigned to receive either the EVPOME or POM to cover the defect in their mouth. The objective of the study is to assess the safety and efficacy for the use of human EVPOME for soft tissue intraoral grafting procedures compared to the "gold standard" palatal oral mucosa (POM) graft.

Eligibility Criteria:
Inclusion Criteria:

* Deficient band (\<3mm) of keratinized mucosa prior to or following dental implant placement
* Surgery to increase width of keratinized mucosa is clinically indicated or requested by the patient to facilitate oral hygiene procedures or to improve esthetics
* Patients in need of a graft of approximately 15 x 10 x 20 mm in dimension

Exclusion Criteria:

* Subjects with potential medical complications such as evidence of clinically significant (as described by investigators) renal, hepatic, cardiac, endocrine, hematologic, autoimmune, or any systemic disease which may complication execution of the protocol and/or interpretation of results
* Current radiation therapy or history of radiation therapy treatment to the intraoral donor biopsy site or recipient site for graft placement
* Documented history of syphilis, HIV, Hepatitis B or C virus
* Pregnant women or women planning to become pregnant or unwilling to abstain or use double barrier contraceptives during the course of the study
* Smoking or use of tobacco products within 6 months prior to screening
* History of either alcohol or drug abuse
* Subjects taking medications that can result in gingival enlargement/overgrowth (Cyclosporine, Dilantin, calcium channel blockers)
* Current use of intravenous bisphosphonate or current oral bisphosphate use or a history of bisphosphonate use for over 5 years
The Role of High Density Surface ECG in the Diagnosis of Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC)

The diagnosis of Arrhythmogenic right ventricular cardiomyopathy can be difficult. The 80 lead ECG may increase the specificity and sensitivity in diagnosing this potentially life threatening inherited cardiac condition. This pilot would form the basis of a much larger clinical trial to test the utility of this novel diagnostic tool.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a confirmed diagnosis of arrhythmogenic right ventricular cardiomyopathy who are being followed up in the cardiology clinic

Exclusion Criteria:

* Inability to consent
* Pacing dependent patients
* Other concomitant cardiag disease e.g. coronary artery disease
* Atrial fibrillation
Anti Vitamin K Therapeutic Education

The purpose of this study is to measure the INR (International Normalized Ratio) time percentage in the target zone (TTR: time in therapeutic range) of children benefiting from the AVK therapeutic education program.


Eligibility Criteria:
Inclusion Criteria:

* age from 0 to 18 years
* AVK prescription
* to accept participating to AVK therapeutic education program
* informed consent form of parents or legal person

Exclusion Criteria:

* parents or legal person refusal to enter in the AVK therapeutic education
Study of the Preventable Passage of Patients Over 75 Years of Age to the Emergency Room of the CHRU of Nancy

The adult emergency service of the Nancy CHRU welcomes an average of 135 visits per day. Approximately 18% are patients over 75 years old, among them 45% go home at the end of their care. The mobile geriatric liaison team intervenes with these patients at the request of the emergency doctors before they return home in order to identify their fragility and implement appropriate measures.

We wish to know the characteristics of these avoidable passages in order to propose preventive measures upstream of these passages. To do this, we need to know the characteristics of those patients with an avoidable passage.


Eligibility Criteria:
Inclusion Criteria:

* age\>=75 years old
* admitted at emergency room between first april 2019 and 30 september 2019
* outpatients

Exclusion Criteria:

* inpatients
* discharged patients
* patients discharged against medical advice
* patients brought by police
Physiological Flow of Liquids in Healthy Swallowing

Thickened liquids are commonly used as an intervention for people with dysphagia (swallowing impairment). However, the field currently lacks a proper understanding of how this intervention works. The overall goal of the project is to collect measurements of bolus flow through the oropharynx (i.e., mouth and throat) during swallowing. The factors that are expected to influence bolus flow include the liquid/food consistency (i.e., thin, slightly-thick, mildly-thick, moderately-thick, extremely thick, solid) and the forces applied during swallowing (i.e., tongue pressures and swallowing muscle contraction). The objective is to determine how these factors interact to influence the flow of a bolus through the oropharynx in healthy swallowing.

The aims of this study are as follows:

Aim 1: To determine the relationship between bolus flow and healthy swallowing physiology. The investigators will collect concurrent videofluoroscopic and physiological measures of swallowing (tongue pressure, electromyography \[sEMG\]) in healthy adults using barium stimuli across the continuum of liquid consistency (thin, slightly thick, mildly thick, moderately thick and extremely thick liquids, as defined by the International Dysphagia Diet Standardisation Initiative, www.iddsi.org). Significance: This will show the impact of consistency on bolus flow through the oropharynx, controlling for the forces used to initiate flow and propel the bolus.

Aim 2: To compare healthy swallowing physiology for barium versus non-barium stimuli. The investigators will collect physiological measures of swallowing using barium and non-barium stimuli matched for consistency. Significance: This will determine how swallowing behaviors (tongue pressures, sEMG) differ between barium and non-barium stimuli with matched consistency, enabling us to develop models of flow accounting for these differences.

Aim 3: To compare healthy swallowing physiology across different commercial barium products. Significance: This will determine whether differences in barium concentration or brand influence swallowing behaviors, enabling us to make recommendations regarding ideal contrast agents for use in radiographic swallowing assessment.

Eligibility Criteria:
Inclusion Criteria:

- healthy adults

Exclusion Criteria:

* prior history of swallowing, motor speech, gastro-esophageal or neurological difficulties, chronic sinusitis or taste disturbance
* history of surgery to the speech or swallowing apparatus (other than routine tonsillectomy or adenoidectomy)
* Type 1 Diabetes
* cognitive communication difficulties that may hinder comprehension of the study documents
* known allergies to latex, food coloring or dental glue
* current pregnancy
* recent x-ray to the neck (in the past 6 months)
* occupationally exposure to radiation exceeding 10 milliSieverts in the year
Amifostine in Treating Patients With Cancer Who Have Neurological Changes Caused by Chemotherapy

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs, such as amifostine, may protect normal cells from the side effects of chemotherapy.

PURPOSE: Phase IV trial to study the effectiveness of amifostine in treating patients with cancer who have neurological changes caused by chemotherapy.

OBJECTIVES: I. Determine the feasibility and tolerability of administering amifostine by intravenous infusion over 5 minutes in cancer patients undergoing chemotherapy.

OUTLINE: This is an open label, controlled study. Patients receive intravenous amifostine over 5 minutes 30 minutes prior to chemotherapy. Patients are followed for one month post treatment.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically or cytologically proven cancer No brain or other CNS metastases (including prior treated metastases)

PATIENT CHARACTERISTICS: Age: 18 and over Performance Status: ECOG 0-1 Life Expectancy: Not specified Hematopoietic: Not specified Hepatic: No grade 3 or greater hepatic dysfunction Renal: No hypercalcemia Cardiovascular: No uncontrolled hypotension Other: Not pregnant or nursing Effective contraceptive method must be used by fertile patients No psychosis No severe concurrent illness other than neoplasia No epileptic seizures during the previous year, migraines, gastrointestinal obstructions, or other causes of vomiting No prior or concurrent amifostine contraindications No prior known contraindications or sensitivity to dexamethasone, granisetron, ondansetron, prochlorperazine, diphenhydramine, cimetidine, or magnesium

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: No prior estrogen within 24 hours of amifostine therapy Radiotherapy: Not specified Surgery: Not specified Other: No prior alcohol, disulphiram, tetracycline, or erythromycin within 24 hours of amifostine therapy No prior antiemetics such as benzodiazepines, antipsychotics, anticonvulsants, or antihistamines within 24 hours of amifostine therapy