cyrilzakka/clinical-trials huggingface dataset:
FAM (Follower, Action Plan, and Remote Monitoring) Intervention to Reduce Severe Hyperglycemia in Adults With Type 1 Diabetes Mellitus at Risk for Diabetic Ketoacidosis

Diabetic ketoacidosis (DKA) results in significant morbidity and healthcare utilization and is the main contributor to loss of life expectancy in people with diabetes mellitus type 1 (T1DM) \<50 years old. This suggests the need to develop interventions to reduce DKA events. Innovative features of newer continuous glucose monitoring devices offer opportunities for novel strategies to reduce DKA. Designating a family member, friend, or caregiver as a Follower was associated with reduction in HbA1C, increased time in range, and improvement in quality of life metrics in people with T1DM. However, the previously published studies are limited as they were either retrospective, survey-based, or do not overlap with our proposed cohort involving adults ages 18-65 with T1DM (prior prospective studies involved either pregnant women with T1DM or adults ≥60 years of age with T1DM). This study is a randomized controlled trial pilot study to evaluate an intervention (FAM) using a Follower, Action Plan, and Remote Monitoring of glucose data to reduce severe hyperglycemia, a modifiable risk factor for DKA, in adults with T1DM at high risk for DKA. The intervention uses real-time glucose data sharing with a Follower (family member, friend, or caregiver) and personalized diabetes education provided to the dyad (person with T1DM and their chosen Follower). The overall hypothesis is that the FAM intervention will improve glycemia with the primary outcome studied in this preliminary pilot study being percentage of time spent with glucose ≥250 mg/dL.


Eligibility Criteria:
Inclusion Criteria:

* People with T1DM for ≥1 year ages 18 - 65
* HbA1C ≥7.5.0% - 14.0%
* If the person with T1DM uses a CGM, the CGM must have the capability of real-time data sharing including glycemic alerts with a Follower (including but not limited to Dexcom G6 or G7 or FreeStyle Libre 2 or 3, or Medtronic Guardian Sensor 3)
* Follower (family member or friend ages 18 years and older) willing to participate in the study and "follow" glucose data and who was no self-reported cognitive impairment
* Ability of the dyad (participant and Follower) to communicate and provide consent in English
* CGM users: ≥50% personal CGM use and ≥50% Dexcom G6 Pro CGM use during the pre-intervention period (days -14 to -1)
* Non CGM users: ≥50% Dexcom G6 Pro CGM use and average ≥2 BGM readings/day during the pre-intervention period (days -14 to -1)

Exclusion Criteria:

* Prisoner
* Active treatment with a sodium-glucose cotransporter-2 inhibitor or planning to start a sodium-glucose cotransporter-2 inhibitor in the next 6 months
* Active malignancy with the exception of non-melanoma skin cancer
* Hospice
* Skin conditions that inhibit wearing a CGM sensor and known severe allergy to adhesives
Atosiban Improves Implantation and Pregnancy Rates in Patients With Repeated Implantation Failure

Atosiban, administered at embryo transfer, can improve the implantation rate and the clinical pregnancy rate in patients with repeated implantation failure undergoing IVF-ET (in-vitro fertilization and embryo transfer).

Atosiban is a mixed oxytocin and vasopressin V1A receptor antagonist.Combined antagonism at oxytocin and vasopressin V1A receptors reduces uterine contractions with a corresponding decrease in intrauterine production of prostaglandin F2alpha and improved uterine blood supply. These effects are of potential benefit for implantation support during IVF-ET cycles.

Eligibility Criteria:
Inclusion Criteria:

* had repeated implantation failure
* have at least 1 good quality embryo for transfer

Exclusion Criteria:

* uterine abnormalities that could compromise the implantation process (e.g. fibroids, endometrial polyp, bicornuate uterus, adhesion of uterine cavity)
Stellate Ganglion Nerve Block in Treating Women With Hot Flashes

RATIONALE: A stellate ganglion nerve block may help relieve hot flashes in women.

PURPOSE: This clinical trial is studying how well a stellate ganglion nerve block works in treating women with hot flashes.

OBJECTIVES:

* To evaluate the impact of stellate ganglion blockade on hot flash scores.
* To evaluate the toxicity of stellate ganglion blockade.

OUTLINE: Patients undergo fluoroscopic-guided stellate ganglion blockade using bupivacaine hydrochloride in week 1.

Patients complete a hot flash diary daily and a symptom experience diary weekly in weeks 1-7 and the Profile of Mood States questionnaire in weeks 1 and 7.

After completion of study treatment, patients are followed at 2 months and then monthly for 1 year.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Presence of hot flashes for ≥ 1 month prior to study registration

  * Hot flashes considered bothersome (defined by their occurrence of ≥ 28 times per week and of sufficient severity to make the patient desire therapeutic intervention)
* Use of more conventional hot flash treatments (including newer antidepressants and gabapentin) have failed to control hot flashes (as defined by the patient)

PATIENT CHARACTERISTICS:

* ECOG performance status 0-1
* Life expectancy ≥ 6 months
* Not of childbearing potential, as judged by the attending clinician
* Able to complete questionnaires alone or with assistance
* No evidence of an active malignancy
* No von Willebrand's disease or other bleeding disorders
* No allergy to chlorhexidine or bupivacaine

PRIOR CONCURRENT THERAPY:

* More than 4 weeks since prior and no concurrent antineoplastic chemotherapy, androgens, estrogens, or progestational agents

  * Tamoxifen, raloxifene, or aromatase inhibitors allowed provided the patient has been on a constant dose for ≥ 4 weeks and continues to receive medication during study treatment
* More than 10 days since prior and no concurrent anticoagulants (e.g., aspirin, clopidogrel, ticlopidine, or warfarin)

  * Concurrent heparin flushes for venous catheter allowed
* No concurrent use of other agents (e.g., megestrol acetate, soy, clonidine, or Bellergal) for treating hot flashes

  * Vitamin E, gabapentin, or antidepressants allowed provided the patient has been on a stable dose for \> 30 days and continues to receive medication during study treatment
Phase I/II Study of Recombinant Human Interferon-gamma (rIFN-gamma) in HIV-Infected Children

PRIMARY: To determine the safety and toxicity of recombinant interferon gamma-1b ( rIFN-gamma ) in HIV-infected children receiving ongoing zidovudine ( AZT ) or didanosine ( ddI ) therapy. To document HIV-associated defects in neutrophil and/or monocyte function that are improved with rIFN-gamma.

SECONDARY: To determine whether a change in CD4 cell count occurs and to assess virologic status and effects on AZT and ddI pharmacokinetics.

It is likely that infants and children severely immunocompromised by HIV infection would respond to immunomodulators that augment different portions of the host defense system. Interferon-gamma has been shown to benefit children with severely compromised nonspecific immunity and may thus be of benefit to those with HIV infection.

It is likely that infants and children severely immunocompromised by HIV infection would respond to immunomodulators that augment different portions of the host defense system. Interferon-gamma has been shown to benefit children with severely compromised nonspecific immunity and may thus be of benefit to those with HIV infection.

Patients are treated with subcutaneous rIFN-gamma 3 times a week for 24 weeks and are then followed for an additional 12 weeks.

Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Required:

* AZT or ddI therapy.
* PCP prophylaxis.

Allowed:

* Antipyretics.
* Antiemetics.
* Antihistamines.
* Decongestants.
* Skin creams and lotions.
* Immunizations according to current recommendations.

Patients must have:

* Class P-2 symptomatic HIV infection.
* Ongoing AZT or ddI therapy of 6 months or longer duration.

Exclusion Criteria

Concurrent Medication:

Excluded:

* Antiretroviral therapy other than AZT or ddI.
* Chemotherapy for active malignancy.
* Amphotericin B for systemic fungal infections.

Patients with the following prior conditions are excluded:

* History of congestive heart failure or arrhythmias.
* History of congenital heart disease.
* History of seizure disorder requiring anticonvulsant medication. (NOTE:

History of uncomplicated febrile seizures does not exclude.)

Prior Medication:

Excluded within 8 weeks prior to study entry:

* Immunomodulators other than IVIG.

Prior Treatment:

Excluded:

* Red blood cell transfusion within 4 weeks prior to study entry.

Required:

* Ongoing AZT or ddI therapy of 6 weeks or longer duration.
* Ongoing PCP prophylaxis for more than 6 weeks duration.

Ongoing alcohol or drug use.
Safety and Efficacy of Triple Combination Therapy With Dorzolamide Hydrochloride / Brimonidine Tartrate / Timolol Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension

This study will investigate the safety and efficacy of Triple Combination Therapy with dorzolamide hydrochloride/brimonidine tartrate/timolol ophthalmic solution in patients with glaucoma or ocular hypertension who have elevated IOP on dorzolamide hydrochloride/timolol maleate combination therapy.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of ocular hypertension or glaucoma in each eye
* Requires IOP-lowering treatment in both eyes

Exclusion Criteria:

* Use of dorzolamide or carbonic anhydrase within 4 weeks
* Any other active ocular disease other than ocular hypertension or glaucoma (eg, uveitis, ocular infections or severe dry eye)
* Required chronic use of ocular medications other than study medication during the study (intermittent use of certain products eg, artificial tears are permitted)
* Use of oral, injectable or topical ophthalmic steroids within 21 days
* Any eye laser surgery within 3 months
* Any intraocular surgery (eg cataract surgery) within 6 months
Antibiotic Concentrations Among Critically Ill Patients

The primary objective of the DALI study is to compare antibiotic concentrations in patient blood samples with bacteriological objectives associated with maximum bactericidal activity. The antibiotics studied are certain lactams and glycopeptides.


Eligibility Criteria:
Inclusion Criteria:

* The patient (or his/her "trusted representative") must have given his/her informed and signed consent
* Antibiotic treatment is administered with beta-lactams or glycopeptides administered continuously or intermittently (Can be of the following: Amoxicillin-clavulanic acid, ampicillin, piperacillin-tazobactam, penicillin G, flucloxacillin, dicloxacillin, cloxacillin, cefazolin, ceftazidime, ceftriaxone, cefepime, meropenem, imipenem, doripenem, ertapenem; Vancomycin, teicoplanin).
* A vein or artery catheter is established to facilitate blood sampling (arterial catheter is preferred)

Exclusion Criteria:

* None of the above-mentioned antibiotics are administered
* Impossible to establish venous or arterial catheter
* Consent not given
* Patient is pregnant, parturient or breastfeeding
* The patient is under tutorship or curatorship
* The patient is participating in another study
Symfony Intraocular Lens Retrospective Chart Review

Retrospective chart review of patients with pre-existing ocular pathology who underwent cataract surgery with implantation of the Symfony IOL.

This was a retrospective chart review conducted at a single US clinical site. Chart review was conducted by John Odette, MD and research assistants. Eligible charts were identified via a clinic database search of cataract surgeries with IOL implantation of the Symfony IOL during the stated date range. Eligible charts included those of patients 18 to 90 years of age who underwent Femto Laser Assisted Cataract Surgery (FLACS) with implantation of a Symfony IOL. Charts were excluded for lack of postoperative follow-up or if Symfony IOL was not implanted. All qualifying patient charts were examined and further classified into 2 groups: (1) eyes with glaucoma; and 2) eyes without glaucoma. Visual acuity was evaluated for patients who underwent cataract surgery with implantation of the Symfony IOL from 09/1/2016 to 05/31/2018. Postoperative evaluations at Month 2 included mean monocular uncorrected visual acuity at near (UNVA) at 40 cm, far distance (UDVA) at 20 ft, and with best correction (CDVA). Outcomes were also compared for toric IOLs versus spherical IOL.

Eligibility Criteria:
Inclusion Criteria:

* :Phacoemulsification cataract surgery with a Symfony IOL.

Exclusion Criteria:

* : Eyes not implanted with a Symfony IOL or unstable refractive results at final post-operative visit
Auditory and Visual Noise as Possible Non-pharmacological Treatment of ADHD in School Children

The goal of this study is to compare the influence of visual and auditory white noise on performance in children with attention deficit hyperactivity disorder (ADHD). The main questions it aims to answer are:

* Can auditory white noise stimulation affect cognitive performance?
* Can visual white pixel noise affect cognitive performance? Participants will complete two eye tracking tasks under different sensory noise stimulation.

Researchers will compare the ADHD group with a group of typically developing children to see if the noise influences the groups differently and if it has the potential to affect the performance of the ADHD group, to reach the level of the control group.

Attention Deficit Hyperactivity disorder (ADHD) is one of the most frequent childhood disorders with an estimated prevalence of about 5%. Multimodal treatment is recommended in both national and international guidelines of ADHD care, but most patients only receive pharmacological treatment, sometimes in combination with parent training. As such, the most common treatment approach today is stimulant medication, e.g., methylphenidate. However, there are insufficient understanding about several aspects of medical treatment. For example, it is not evident that medication improves learning processes and the best dosage for cognitive functioning and adapted school behavior differs.

Original findings from our research group shows that auditory noise has the possibility of enhancing cognitive performance in inattentive children without diagnosis as well as children with an ADHD diagnosis. One study found that the benefit of noise was in parity with, or even larger than, the benefit of pharmacological ADHD treatment on two cognitive tasks. The theory about noise benefit is thoroughly described by Sikström and Söderlund (2007). If auditory or visual noise, as suggested by the present project, could be a complement, or an alternative, to stimulant medication it could fundamentally change the treatment of ADHD and the school situation for those children.

The aims of this study are to: i) evaluate the effects of auditory white noise and visual white pixel noise on cognitive performance during two eye tracking tasks, ii) compare effects between ADHD and control groups ii) link noise benefit to specific traits.

Eligibility Criteria:
Inclusion Criteria:

* Children and adolescents with a diagnosis of ADHD and control children without a diagnosis

Exclusion Criteria:

* Intellectual disability
* Psychosis
* Severe depression or anxiety
* The need of an interpreter to participate in the study
Effect of Bradykinin Receptor Antagonism on ACE Inhibitor-associated Angioedema

Individuals with heart disease or high blood pressure are often prescribed angiotensin converting enzyme (ACE) inhibitors to treat their disease. However, the use of ACE inhibitors can be associated with angioedema, a rare but life-threatening condition that causes swelling of the face and other body parts. This study will evaluate the effectiveness of the drug HOE-140 at decreasing symptoms of angioedema in people taking ACE inhibitors who develop the condition.

People who take ACE inhibitors may develop angioedema, a condition that causes itchy and painful swelling beneath the skin around the eyes, lips, tongue, throat, hands, or feet. In severe cases, the throat may swell, obstructing the airway and leading to breathing difficulty. ACE inhibitors prevent the breakdown of a natural chemical in the body called bradykinin. Increased levels of bradykinin, which can cause swelling, may contribute to the development of angioedema. Blocking bradykinin receptor cells prevents bradykinin from initiating swelling and may lead to a possible decrease in angioedema symptoms. The purpose of this study is to evaluate the effectiveness of HOE-140, a bradykinin receptor blocker, at reducing symptoms in people with ACE inhibitor-associated angioedema.

This study will enroll people admitted to the emergency room or hospital who have a severe case of ACE inhibitor-associated angioedema. Participants will be randomly assigned to receive an injection of either HOE-140 or placebo. Initially, participants will undergo an electrocardiogram to measure the electrical activity of the heart. Then blood pressure measurements, blood collection, a physical exam to determine the extent and duration of swelling, and photographs of the swelling will occur at 2, 4, 8, 16, and 24 hours following the start of treatment. Questionnaires will be completed by study staff and participants to assess changes in angioedema symptoms and the extent of swelling. Participants will remain in the hospital for 24 to 48 hours, depending on the severity of their symptoms. Blood will be collected at a follow-up visit that will occur 7 days after the resolution of angioedema symptoms.

Eligibility Criteria:
Inclusion Criteria:

* The subject has ongoing angioedema while taking an ACE inhibitor.
* The subject is between 18 and 80 years of age.

Exclusion Criteria:

* The subject has had angioedema while not taking an ACE inhibitor.
* The subject's angioedema only involves the bowel.
* The subject is known to be pregnant or has a positive urine pregnancy test.
* The subject has started on an oral contraceptive within the last 6 months.
Effect of Cervical Occlusion During Intrauterine Insemination (IUI)

Study Hypothesis: There is a difference in pregnancy rates between intrauterine insemination (IUI) in cycles performed with cervical occlusion by a balloon catheter designed for sonohysterograms as compared to those performed with a standard inseminator.

The investigators will compare pregnancy rates in patients undergoing routine IUI either with balloon occlusion or with standard insemination. The patients will receive the standard clinical care per the investigators' office guidelines, except they will be randomized to insemination with either of two catheters.

An open speculum will be used and patients will undergo insemination with their partners sperm (same quantity in both arms). If randomized to treatment arm a balloon catheter will be filled with 1cc of air prior to insemination. The speculum will be removed immediately and the catheter will be left in for 15 minutes and then removed. Pregnancy outcomes will be recorded in both groups.

Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing IUI for unexplained infertility in our office: Center for Reproduction and Infertility (Providence, RI)

Exclusion Criteria:

* "Abnormal" Semenalysis TMC \< 5 million
* Blocked Fallopian tubes
Evaluation of Pharmacokinetic and Pharmacodynamic Characteristics of Indobufen, an Anticoagulant Agent

This study is designed to evaluate the pharmacokinetic and pharmacodynamic characteristics of indobufen in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Adult males aged 19 to 50 years at screening.
* Subjects with body weight ≥ 45 kg and within ±20% of the ideal body weight : Ideal body weight = (height \[cm\] - 100)x0.9.
* Subjects who have received and understood completely the information regarding the current study and given written informed consents to voluntarily participate in the study and followed all instructions specified in the protocol.

Exclusion Criteria:

* Subjects who have drunken habitually (exceeding 21 units/week, 1 unit = 10 g of pure alcohol) or who are unable to abstain from drinking during the study period from 2 days prior to the first administration of investigational product and during this study.
* Subjects deemed ineligible by investigator based on other reasons, including abnormal laboratory values or diseases.
Effectiveness of Bioactive Resin Varnish and Fluoride Containing Xylitol Varnish in Management of Teeth Hypersensitivity

Will the use of Bio-smart Light Cured Protective Shield with bioactive S-PRG filler or the use of Sodium Fluoride with Xylitol-coated Calcium and Phosphate (CXP™) Varnish be able to reduce the teeth hypersensitivity similar to Sodium Fluoride Varnish?

The null hypothesis tested in this study, that there is no difference in clinical effectiveness between bio-smart Shield with bioactive S-PRG filler and Fluoride varnish containing Xylitol-coated Calcium and Phosphate (CXP™) Compared to Sodium Fluoride Varnish in management of hypersensitivity in adult patients after 3 minutes, 2, 4 and 8 weeks.

P (Population): Patient with Teeth Hypersensitivity.

Intervention-1: Bio-smart Light Cured Protective Shield with bioactive S-PRG (Surface Pre-Reacted Glass ionomer) filler technology (PRG Barrier Coat) by (By SHOFU Inc., Japan).

Intervention-2: 5% Sodium Fluoride with Xylitol-coated Calcium and Phosphate (CXP™) Varnish (Embrace™ Varnish) by (Pulpdent Corporation)

C (Comparator): 5% Sodium Fluoride Varnish (Duraphat®) by (Colgate Palmolive Company, New York, NY)

O (Outcome):

* Primary Outcome: Pain due to Hypersensitivity
* Secondary Outcome: Dentinal tubules occlusion

Eligibility Criteria:
Inclusion Criteria:

* Patients complaining of hypersensitive areas on facial surfaces of the teeth (incisors, cuspids, bicuspids, and first molars with exposed cervical dentin)

  * Teeth scoring pain (VAS score: greater than or equal to 5) during application of stimulus (air blast, thermal and tactile sensitivity test).
  * Patients with good oral hygiene.
  * Co-operative patients who show interest to participate in the study accept the 2-months follow-up period.

Exclusion Criteria:

* Patients participating in another dental study that may alter the results of this study.
* A medical condition that could hinder the accuracy of pain reporting (e.g., pain disorders).
* Any chronic medical condition that requires the regular use of anti-inflammatory pain medications.
* Patients used or applied a desensitizing varnish within the last four weeks.
* Patients with dental problems; chipped teeth, defective restorations, fractured Un-displaced cuspids or deep dental caries.
* Patients with orthodontic appliances, or bridge work that might interfere with evaluation
* Lack of patient's approval and compliance.
* Patients who are allergic to any ingredients will be used in the study.