cyrilzakka/clinical-trials huggingface dataset:
S.K.A.T.E.: Safety of Keppra as Adjunctive Therapy in Epilepsy

The purposes of the study were to obtain further information about the optimal dose and the efficacy of Keppra in daily clinical practice, and to confirm the favorable safety and tolerability profiles of the drug observed during clinical development.


Eligibility Criteria:
Inclusion Criteria:

* Partial onset seizures, whether or not secondarily generalized;
* at least 1 partial seizure and no more than 14 partial seizures per month as measured by historic baseline;
* using 1, but no more than 2 concomitant marketed antiepileptic drugs (AEDs) at the time of study entry.

Exclusion Criteria:

* Presence of known pseudoseizures within the last year;
* presence or history of allergy to the components of Keppra (levetiracetam, lactose, cornstarch, and excipients) or other pyrrolidine derivatives;
* on felbamate with less than 18 months exposure;
* on vigabatrin, but visual field had not been assessed as per recommendation of the manufacturer, i.e., every 6 months;
* uncountable seizures (clusters) or history of convulsive status epilepticus within the last 5 years.
Follow-up With Preimplantation Genetic Testing Patients

The main purpose of this study is to perform longitudinal evaluations of clinical outcomes and personal perspectives following utilization of preimplantation genetic testing (PGT). Patients indicating willingness to participate in research during informed consent to perform PGT will be eligible for inclusion. A licensed genetic counselor will conduct a recorded interview.

Purpose: To perform longitudinal studies of clinical outcomes and personal perspectives following utilization of PGT.

Background: Preimplantation Genetic Testing (PGT) is a commercially available adjunct to in vitro fertilization (IVF) and is now performed in over 40% of treatment cycles in the United Sates (Society for Assisted Reproductive Technology Annual Report, 2018). Several clinical genetics entities offer PGT services, including Genomic Prediction Clinical Laboratory (CLIA# 31D2152380, CAP# 8488628). It is common practice to perform interviews with, and record reviews of patients following clinical interventions. Results may provide instrumental information for the scientific and medical community to improve clinical care. We would like to review medical records in order to recruit patients to participate in longitudinal studies of clinical outcomes and personal perspectives following utilization of PGT.

Study Design and Methods: Patients indicating willingness to participate in research during informed consent to perform PGT will be eligible for inclusion. Patients who opted out of participating in research during informed consent to perform PGT will be ineligible for inclusion. Clinical PGT consent forms will be reviewed to identify patients that indicated willingness to participate in research. Eligible patients will be counseled on the study and consented for participation by a licensed genetic counselor. A total of 10,000 patients will be recruited. Following patient recruitment and informed consent, patient records and results of patient interviews may be used for publication in peer-reviewed scientific journals, presentation at scientific conferences or company meetings. As it is in standard practice, all external communication of results will maintain de-identification of all protected health information of all subjects (HIPAA guidelines). A licensed genetic counselor will conduct a recorded interview. Patient PGT, family history, and ethnicity data and information may be included in cohort analyses.

Eligibility Criteria:
Inclusion Criteria:

* Patients indicating willingness to participate in research during informed consent to perform PGT

Exclusion Criteria:

* Patients who opted out of participating in research during informed consent to perform PGT
The Effect of Robot-assisted Gait Training on Gait Ability in Children With Cerebral Palsy Through Changing Gait Speed

Robot-assisted gait training (RAGT) improves the gait ability of children with cerebral palsy, and can provide treatment plans and guidelines through changed records of various gait variables. There is a lack of concrete explanations or arguments for gait speed, weight support ratio, support force, joint angle, etc. that can be set in the RAGT system, and intervention intensity for an appropriate intervention program has not been presented. Therefore, in this study, we would like to suggest clinically effective interventions for children with cerebral palsy in the second stage of the gross motor function classification system (GMFCS) by identifying gait variables according to differences in gait speed during RAGT.


Eligibility Criteria:
Inclusion Criteria:

* Patients 4-12 years old diagnosed with cerebral palsy
* Children who have not received botulinum toxin treatment or surgery within 3 months
* Children in stage 2 of the gross motor function system
* Children who can express pain, fear, or discomfort on their own

Exclusion Criteria:

* Severe lower extremity contracture and fracture
* Bone instability
* Osteoporosis
* Severe bones grow disproportionately
* Unhealed skin lesions on the lower extremities (thromboembolic disease)
* Thromboembolic disease
* Cardiovascular instability
* Mild scoliosis with a Cobb's angle of more than 20 degrees
Pacific Northwest Female Urinary Incontinence Treatment Digital Awareness Project

The investigators will compare whether advertisements on Google or Facebook are more effective to reach women in the Pacific Northwest about treatment options for urinary incontinence through the American Urogynecologic Society's patient education website, VoicesForPFD.org. The investigators hypothesize there is no difference in the overall population engagement between these two platforms due to anticipated higher reach through Facebook based on user characteristics but higher engagement through Google due to higher user interest on this platform.

The investigators will conduct a comparative ecological study to compare effectiveness of two different targeted digital outreach platforms to engage women at risk for urinary incontinence in the Pacific Northwest. Counties in Oregon, Washington, Idaho will be randomized to receive advertisements for the American Urogynecologic Society's patient education website (domain VoicesForPFD.org) via either Google or Facebook. The investigators will use advertising campaigns developed specifically for this purpose. Through website analytics measuring advertisement clicks and census population data, the investigators will estimate utilization rates of the website for each county among the target population of middle-aged women to determine if one platform is more effective than the other for this topic and population.

Eligibility Criteria:
Inclusion Criteria:

- Internet user in Idaho, Oregon, or Washington states

Exclusion Criteria:

* Identified geographic location outside Idaho, Oregon, or Washington states
* Users identified by the advertising platforms as male.
Intraocular Pressure Fluctuation in Patients With Glaucoma and in Healthy Patients During Standard Yoga Positions

The purpose of the study is to investigate the IOP difference between normal and glaucomatous eyes using standard ophthalmic tonometry devices while subjects are performing different standard yoga asanas. The IOP of participants will be measured prior, immediately at start of the asana, 2 minutes into the asana, and immediately after assuming a sitting position. The patient will wait 10 minutes and a final IOP will be taken. Four standard yoga asanas will be tested.


Eligibility Criteria:
Inclusion Criteria:

* Glaucoma or healthy control
* Practice yoga
* 18-80 years old
* Practice Yoga for a minimum of 12 months

Exclusion Criteria:

* Healthy subjects do not have normal ophthalmic exam
* Cannot maintain yoga positions
The Effect of Health Provider's Feedback on Physical Activity Surveillance Using Wearable Device-Smartphone Application for Resolution of Metabolic Syndrome

The Effect of Health Provider's Feedback on Physical Activity Surveillance using Wearable Device-Smartphone Application for Resolution of Metabolic Syndrome; a 12-Week Randomized Control Study

Patients diagnosed with metabolic syndrome were recruited and prescribed to live for 12 weeks using a wrist-wearable device (B.BAND, B Life Inc, Korea). The block randomization method was used to distribute the participants between an intervention group (n=35) and control group (n=32). In the intervention group, an experienced study coordinator provided feedback on physical activity to individuals through telephone counseling every other week.

Eligibility Criteria:
Inclusion Criteria:

* smart phone user

Exclusion Criteria:

-
A Study to Compare Efficacy and Safety of Trifarotene Cream When Used With an Oral Antibiotic for the Treatment of Severe Acne Vulgaris (AV)

The purpose of this study was to demonstrate that daily use of topical trifarotene (CD5789) 50 microgram per gram (mcg/g) cream when used in association with oral antibiotic is safe and effective for the treatment of severe AV.


Eligibility Criteria:
Inclusion Criteria:

* Participants with clinical diagnosis of acne vulgaris, defined by IGA score of 4 (Severe)
* Participants with at least 20 inflammatory lesions (papules and pustules) and 30 to 120 non-inflammatory lesions (open comedones and closed comedones) and no more than 2 nodules (less than \[\<\]1 centimeter \[cm\] in diameter) on the face, excluding the nose
* Agrees to provide written informed consent
* Participant is a female of non-childbearing potential (premenarchal or postmenopausal \[absence of menstrual bleeding for 1 year prior to Screening, without any other medical reason\], hysterectomy or bilateral oophorectomy)

Exclusion Criteria:

* Participant with any acne cyst on the face
* Participants with nodulocystic or conglobate acne, acne fulminans, or secondary acne (chloracne, drug-induced acne, etc.)
* Participants with facial dermal conditions (example \[e.g.\] tattoo, skin abrasion, eczema, sunburned skin, scars, nevi, etc.) that may interfere with study assessments in the opinion of the investigator
* Participants who is at risk in terms of precautions, warnings, and contraindications for trifarotene or doxycycline hyclate
* Currently receiving any prescription testosterone therapy (e.g., testosterone cypionate, testosterone enanthate, testosterone pellet, testosterone undecanoate) or on a testosterone booster or prescription testosterone (e.g., dehydroepiandrosterone \[DHEA\], Omnadren, Sustanon, testosterone cypionate, testosterone enanthate, testosterone propionate, testosterone phenylpropionate) or testosterone supplements (e.g., Tribulus).
Maxillary Sinus Elevation and Perioperative Complications

This study aims to investigate the effects of various external sinus lifting techniques on patient comfort and perioperative complications.

Patients who met the inclusion criteria and were admitted for posterior maxilla rehabilitation participated in this prospective, randomized, controlled clinical trial. The three methods used to lift the sinuses were randomized: piezosurgery using a surgical guide, a drill specifically made for lateral sinus lift, and traditional drills. Recorded were the duration of the procedure, accessibility, and intraoperative complications. During the first week following surgery, analgesic intake and pain using a visual analog scale (VAS) were assessed assessed. Preoperatively and on the second and seventh postoperative days, edema was assessed. Preoperatively and on the seventh postoperative day, the patient\&#39;s quality of life using the OHIP-14 questionnaire, experiences, and expectations were evaluated.

Eligibility Criteria:
Inclusion Criteria:

1. Severe resorption or sinus pneumatization in the posterior maxilla that prevents standard implant treatment; class V or VI according to Cawood and Howell classification, patients with residual bone height less than 6 mm
2. Patients over 18 years of age
3. Patients without a history of reconstructive pre-prosthetic surgery or previous implant surgery
4. Patients with partial edentulism who have applied to our center for implant treatment and need sinus lifting
5. Patients with cone beam computed tomography (CBCT) taken within the last 1 month

Exclusion Criteria:

1. Patients with a history of systemic diseases (hematologic, neurologic, etc.) that may be contraindicated surgery
2. Patients who are pregnant or in lactation period
3. Patients with a history of immune system disorders and substance abuse
4. Patients with a history of radiotherapy in the head and neck region
5. Patients with existing maxillary sinus pathology or who have undergone surgery
6. Patients who smoke \&gt;10 cigarettes per day
7. Patients using antibiotics or steroids in the 30 days before surgery
8. Uncooperative patients who do not comply with the study protocol or follow-up regimen
9. Patients with perforation of the Schneiderian membrane
Effects of Prebiotics on GLP-1 in Type 2 Diabetes

The aim of the study is to compare the effects of prebiotics versus placebo on blood concentrations of glucagon-like peptide-1 in subjects with diabetes type 2.

We looked at 6 weeks supplementation with a prebiotic fibre mix of inulin and FOS. Cross over design compared to maltodextrin as placebo. Additional outcome measures: blood glucose, insulin, GLP-2, ghrelin, PYY and leptin after a standardized mixed meal test. Also measured changes in microbiota composition and SCFA in feces before and after intervention/placebo periods, and subjective measures of appetite.

Eligibility Criteria:
Inclusion Criteria:

* diabetes type 2
* BMI 18,5 - 40
* Not medicated with insulin, GLP-1 analogues or DPP4 inhibitors
* Moderate intake of alcohol
* Not excessive exercise
* Less than 3 kg weight change the last two months
* Intake of less than 30 g dietary fiber per day

Exclusion Criteria:

* IBD
* IBS
* Coeliac disease
* Have used antibiotics within the last two months
* Have used supplements with prebiotics or probiotics the last two months
* Pregnancy
Anxiety and Depression Levels in Cancer Patients After Self-Application of EFT (Emotional Freedom Techniques)

Anxiety and depression have been found to be significant co-occurring conditions in cancer patients. This study examines these and other psychological conditions in patients diagnosed with cholangiocarcinoma, a rare cancer of the bile duct, with an average survival time of three to six months post-diagnosis. Participants are taught EFT in telephone and internet group coaching sessions, and have access to an online support forum. They complete the Mini-Mental Adjustment to Cancer Scale (Mini-MAC), EORTC Quality of Life scale, the PTSD checklist, the Patient Health Questionnaire, and a brief health checklist. Participants also provide medical records confirming their diagnosis, and markers, both before and after the study. The study is expected to enroll 20-15 cholangiocarcinoma patients, and use a within-subjects, time series, repeated measures design. Symptoms are assessed prior to coaching, after four, and again after eight weekly coaching sessions. Follow-ups will occur in one month, three months, and one year. It is hypothesized that a drop in the severity of co-occurring psychological symptoms, pain and insomnia may occur after EFT coaching.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of cholangiocarcinoma
* Ability to complete forms and attend phone coaching sessions

Exclusion Criteria:

* None
Comparison of Ponseti Method Versus Older Treatments in Talipes Equinovarus Through Gait Analysis and Clinical Results

There are many different treatments of congenital talipes equinovarus. At our institution, the investigators use the Ponseti method with manipulation and immobilization of the foot. In this study the investigators should like to demonstrate the better outcome in clinical results and in gait analysis of patients treated with the Ponseti method, compared to the 'older' methods of taping and posteromedial release.

There are many different treatments of congenital talipes equinovarus. At our institution, the investigators use the Ponseti method with manipulation and immobilization of the foot. In this study the invistigators should like to demonstrate the better outcome in clinical results and in gait analysis of patients treated with the Ponseti method, compared to the 'older' methods of taping and posteromedial release. Trial objectives With this study the investigators would like to investigate whether clinical results and gait analysis in patients treated with Ponseti has better results compared to patients treated with the older methods.

Eligibility Criteria:
Inclusion Criteria:

* All patients with talipes equinovarus who have been treated at our institution

Exclusion Criteria:

* Patients with other disorders which may influence the clinical or gait analysis outcome
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IONIS ANGPTL3-LRx in Healthy Volunteers With Elevated Triglycerides and Participants With Familial Hypercholesterolemia

The purpose is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of IONIS ANGPTL3-LRx (ISIS 703802) given to healthy volunteer subjects with elevated triglycerides and subjects with familial hypercholesterolemia.


Eligibility Criteria:
Inclusion Criteria for All Cohorts:

* Must have given written informed consent and be able to comply with all study requirements
* Males or females 18 to 65 years, inclusive, at the time of informed consent
* Body Mass Index (BMI) ≤ 35.0 kg/m2
* Females must be non-pregnant and non-lactating, and either surgically sterile or postmenopausal.
* Males must be surgically sterile, abstinent or using an acceptable contraceptive method

Inclusion criteria for Cohorts, A, D, and AA to DD only:

* Fasting triglycerides (TG) ≥ 150 mg/dL at Screening
* Fasting low density lipoprotein cholesterol (LDL-C) \> 70 mg/dL at Screening

Inclusion criteria for Cohorts B and C only:

* Fasting TG 90 - 150 mg/dL at Screening
* Fasting LDL-C \> 70 mg/dL at Screening

Inclusion Criteria for Cohort EE Only:

* Homozygous FH diagnosis and fasting LDL-C ≥ 190 mg/dL (4.9 mmol/L)

Inclusion Criteria for Cohort FF Only:

* Heterozygous FH diagnosis and fasting LDL-C ≥ 160 mg/dL (4.1 mmol/L)

Inclusion Criteria for Cohorts EE and FF Only:

* Maximally tolerated stable LDL-C lowering agents (stable for at least 12 weeks)
* On stable low-fat diet
* Stable weight (± 4 kg) for ≥ 6 weeks prior to screening

Exclusion Criteria for All Cohorts:

* Known history or positive test for Human Immunodeficiency Virus (HIV), Hepatitis C (HCV), or Hepatitis B (HBV)
* Treatment with another Study Drug, biological agent, or device within one-month or 5-half-lives of screening
* Regular use of alcohol within 6 months of screening
* Use of concomitant drugs unless authorized by the Sponsor Medical Monitor
* Known contraindication and/or allergy to heparin
* Smoking \> 10 cigarettes a day
* Considered unsuitable for inclusion by the Principal Investigator

Exclusion Criteria for Cohorts EE and FF:

* Myocardial infarction, percutaneous transluminal coronary intervention, or coronary artery bypass graft surgery within 12 weeks prior to screening, or cerebrovascular accident within 24 weeks prior to screening. Participants with adequately treated stable angina, per Investigator assessment, may be included
* Congestive heart failure defined by NYHA Classes III or IV
* Type 2 diabetes mellitus (T2DM) with HbA1c \> 8.0%
* Prior treatment with gene therapy
* Currently receiving apheresis treatments or last apheresis treatment was within 8 weeks of screening
Genetic Risk Estimation of Breast Cancer Prior to Preventive Medication Uptake

The primary aim of this study is to determine if the addition of an individual polygenic risk score (PRS), in addition to the standard National Cancer Institute's Breast Cancer Risk Assessment Tool (BCRAT) or Tyrer-Cuzick (IBIS) score, will aid women at risk of breast cancer in making a decision to take (or not take) medications to prevent breast cancer

This trial is a prospective pilot study looking to integrate a novel and retrospectively validated polygenic risk score (PRS), based on 77 Single Nucleotide Polymorphisms (SNPs), into a standard breast cancer prevention consultation for non-BRCA women. In order to be eligible for trial participation, women will need to have a BCRAT estimate of ≥3% for the 5 year risk of developing breast cancer (which corresponds to the United States Preventative Services Task Force threshold for moderate to strong benefit from breast cancer preventing medications such as tamoxifen or raloxifene.

At the time of the breast cancer prevention consultation, women will be offered participation in this study by a clinical trials nurse and informed written consent will be obtained. For consenting patients, a single 7 to 10 ml blood sample will be taken and couriered to the MAYO clinic for sample analysis and several surveys will be administered. One of the surveys will assess the participants understanding and intention to take or not take breast cancer preventing medications. The decision to take or not take a breast cancer preventing medication will be deferred until a subsequent follow up visit.

On the second visit, the PRS test results will be reviewed with the patient and a recommendation regarding preventive medications will be made. The PRS score will risk stratify patients into one of three lifetime risk categories of developing breast cancer (low risk (\<15 % lifetime risk), above average risk (15 to \<40% risk) and high risk (\>40%)). Participants will then answer a second survey in which their understanding of their breast cancer risk and intention to take breast cancer preventing medications will be assessed.

Eligibility Criteria:
Inclusion Criteria:

1. Women \> 35 years old and \< 75 years old
2. Women with either of the following:

   A. a NCI-BCRAT 5 year risk of ≥ 3% which corresponds to the level in which there is moderate evidence of treatment benefit outweighing risk according to the US Preventative Services Task Force (32); or B. Women with a IBIS (Tyrer-Cuzik) score for the 10 year risk of breast cancer of ≥5%
3. Able to participate in all aspects of the study
4. Understand and signed the study informed consent

Exclusion Criteria:

1. Women whose BCRAT falls below the threshold (\<3 % 5 year risk) of moderate benefit according to the US Preventative Task Force AND Women whose IBIS score is \<5% for the 10 year risk
2. Women with known BRCA1 and BRCA2 mutations
3. Women with known contra-indications to Tamoxifen, raloxifene or exemestane
4. Unable to give informed consent
5. Prior history of invasive breast cancer or ductal carcinoma in situ
6. At risk due to prior radiation therapy to the chest