cyrilzakka/clinical-trials huggingface dataset:
Inherited Myokymia: A Clinical and Genetic Study of a Family

Neuromyotonia (NMT), so called Isaac's syndrome, is a rare disorder in which hyperexcitability of peripheral motor nerves leads to intermittent muscle contractions. It is characterized by muscle twitching at rest (visible myokymia), cramps, hyperhidrosis, paraesthesiae, mild muscle weakness. and impaired muscle relaxation, or pseudomyotonia. Electromyographic recording is a key diagnostic tool in detecting myokymia and neuromyotonia. Pathophysiology of neuromyotonia is claimed to be related immune disorder, autoimmune anti-voltage-gated potassium-channel antibodies and genetic mutation in potassium channel. KCNA1 (Kv1.1) mutation was mostly reported in a autosomal dominant trait. In the present study, we report a family affected with myokymia，worsening with elevated body temperature, febrile illness or spicy food. How the change in temperature influence clinical features of channelopathies is an interesting topic. Variant clinical severity of family members are recorded. The index patient has possible autoimmune mechanism involvement because of his clinical feature of myasthenia gravis with thymoma and hyperthyroidism. Further analyzing the genetic mutation in potassium channelopathy may provide researchers some pathophysiological insight into the Isaac's syndrome.


Eligibility Criteria:
Inclusion Criteria:

* The disease was initially diagnosed of Isaacs syndrome by two neurologist(Dr Tsai and Dr Yang). We will recruit family members of diseased patient and normal subjects for clinical, electromyographic and genetic studies.

Exclusion Criteria:

* none
Observational Study to Investigate Resistant Hypertension Prevalence in Korean General Hospitals

Study Objectives The study is to identify prevalence, demography and clinical characteristics of patients with resistant hypertension among hypertensive patients who have been treated in general hospitals in Korea from Jan 2012 to Jun 2012.

* Diagnosis of resistant hypertension: In case of clinic blood pressure exceeding the boundary of systolic blood pressure at 140mmHg and diastolic blood pressure at 90mmHg (hereinafter refer to as 140/90mmHg) (130/80mmHg for patients with diabetes mellitus or chronic renal disease) despite triple antihypertensive therapy at optimal dose may be diagnosed as resistant hypertension. Antihypertensive medications used include diuretics. Resistant hypertension may also be diagnosed when clinic blood pressure has reached the target value but quadruple or more of antihypertensives are used.
* Diagnosis of controlled hypertension: Patients whose clinic blood pressure equals to 140/90mmHg (130/80mmHg for patients with diabetes mellitus or chronic renal disease) or less with the administration of antihypertensives at optimal dose may be diagnosed as controlled hypertension.

Primary Objective:

Prevalence in patients with resistant hypertension among hypertensive patients who have been treated in Korean general hospitals

Secondary Objectives:

Analysis of correlation in patients with resistant hypertension and patients with controlled hypertension who received triple antihypertensive therapy in terms of demography, clinical characteristics and other factors

1. Demographic data (age, sex, and body mass index)
2. Clinical characteristics

   * Vital signs
   * Lifestyles (history of drinking, smoking, and exercise)
   * Family history (hypertension, diabetes mellitus, dyslipidemia, cardiovascular disease, renal/adrenal disease, cerebrovascular disease, and respiratory disease)
   * Concurrent diseases (diabetes mellitus, dyslipidemia, cardiovascular disease, renal/adrenal disease, cerebrovascular disease, respiratory disease, and others)
   * History of antihypertensive therapy (past and present)
   * Medication compliance of antihypertensives
   * Concomitant medications

Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed of hypertension and in 20 years of age or older at the time of participating the study
2. Patients visiting the medical institution during the period of 01 2012 \~ 06 2012 and who have received triple or more of antihypertensive therapy including diuretics (all different classes one another) at the time of the investigation.
3. Patients who signed the informed consent form for data use before undergoing the study procedures.
4. Patients who have capability and are willing to understand and fill in the questionnaire used in this study or who have a representative to fill in the questionnaire in case of lacking the capability.

Exclusion Criteria:

1. Patients who fail to meet the inclusion criteria.
Interactive AI-based Mental Health Service for the Patients With Cancer

The aims of this study are developments of mental health care services for cancer patients based on interactive artificial intelligence. To do these things, survey of unmet medical needs and data collection of clinical interviews will be done, and newly developed assessment and intervention scenarios will be simulated to cancer patients group.

A total of 20 people will be recruited from 3 institutions to investigate unmet medical needs. Based on the needs, we will develop scenarios to assess, classify, explain and conduct supportive interviews. We plan to develop a stress self-management scenario that helps manage lifestyle habits and provides meditation-based cognitive therapy. For moderate to severe distress, we plan to develop scenarios to link medical care and manage suicide risk. We plan to conduct interviews with a total of 300 people to collect clinical interview data for scenario development.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with malignant tumor and undergoing treatment, or patients undergoing follow-up after completing curative treatment

Exclusion Criteria:

* Patients unable to consent to research or be interviewed due to cognitive decline
Accuracy of Navigation in Placement of Sacroiliac Screw

The purpose of this study is to compare the precision of computer-assisted navigation for hip screw implantation to conventional fixation without navigation.

Standard treatment for sacroiliac dislocations and sacroiliac fractures is placement of two screws through the iliosacral joint into the sacral ala or the body of the S1 vertebra. Correct positioning is technically demanding. Screw displacement may reduce the strength of fixation and lead to neurological complications.

Secondary objectives of the study are to compare the fluoroscopy time, complications and surgery duration between the treatments.

Eligibility Criteria:
Inclusion Criteria:

* Radiologically confirmed sacroiliac dislocation or sacroiliac fracture
* Sacroiliac arthritis
* Age 18 years and more
* Written informed consent by patient or his/her legal representative

Exclusion Criteria:

* Poor life expectancy (\<3months)
* Fracture of pathologic origin
* History of substance abuse (recreational drugs, alcohol)within 12 months prior to screening
* Prisoner
* Currently involved in another study that precludes or complicates participation
* Disease or condition that would preclude accurate evaluation (e.g., significant psychiatric disease)
Drug Use Investigation Of Zyvox (Linezolid) (Regulatory Post Marketing Commitment Plan)

Drug use investigation of Zyvox for patients with Methicillin-resistant Staphylococcus aureus (MRSA) infection disease.

The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the Package Insert (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.

All the patients whom an investigator prescribes the first Linezolid should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.

Eligibility Criteria:
Inclusion Criteria:

* Patients need to be administered Linezolid in order to be enrolled in the surveillance.

Exclusion Criteria:

* Patients not administered Linezolid.
Electrical Stimulation for Critically Ill Post-Covid-19 Patients

Unfortunately, hospital-acquired weakness is highly prevalent among COVID-19 hospitalized patients, who often require prolonged bed-rest or paralytics for an extended period of time in order to maintain oxygenation. Prolonged bed rest has been associated with pronounced loss of muscle mass that can exceed 10% over the 1st week, which leads to functional impairment and complications post-hospital discharge. Physical therapy and in-hospital mobility program may reduce the incident of hospital-acquired weakness, but they are often impractical for COVID-19 patients. In particular, conventional mobility programs are challenging for those who are being treated in an intensive Care Unit. The purpose of this study is to test feasibility and proof-of-concept effectiveness of daily use of lower extremity electrical stimulation (EE) therapy, as a practical solution to address lower extremity muscle deconditioning, to address chronic consequences of COVID-19 including hospital-acquired weakness.

20 subjects that were hospitalized due to severe COVID-19 infection and present neuromuscular complications (i.e., hospital acquired weakness due to neuromyopathy) will be recruited after the first phase of this study is completed. Unlike Phase I (study for prevention), this is a proof of concept randomized control trial (RCT) study for recovery. The patients will be recruited from the COVID-19 Clinic at Baylor College of Medicine and will begin the study after being diagnosed with neuromyopathy due to prolonged hospitalization for COVID-19. This will be performed by a critical care and pulmonary specialist at the BCM COVID-19 Clinic. The entire cohort will receive daily electrical stimulation in lower extremity (e.g. Gastrocnemius, tibial anterior muscle) up to 1 hour to recover from Neuromyopathy complications and prolonged hospital stay. Participants will be randomized to intervention (IG) or control group (CG)). EE therapy will be provided using a bio-electric stimulation technology (BEST) platform (Tennant Biomodulator PRO®, AVAZZIA, Inc.). The EE device will be functional for IG and non-functional for CG. In addition to taking the device home to deliver electrical stimulation themselves, the patients will attend a weekly assessment at the McNair Campus for up to 4 weeks. The primary outcomes include between group difference and change from the baseline in muscle endurance, muscle strength, lower extremity tissue oxygen saturation, neuropathy, and muscle atrophy.

Eligibility Criteria:
Inclusion Criteria:

* Post-COVID-19 patients who required hospitalization due to COVID-19 severe infection.
* Post-COVID-19 patients who required hospitalization and present neuromuscular sequelae due to COVID-19 severe infection.

Exclusion Criteria:

* Patient has a demand-type cardiac pacemaker, implanted defibrillator or other implanted electronic device.
* Active wound infection.
* Below the knee amputations.
* Based on the clinicians decision whether the patient is eligible for the study.
Immediate Post-placental Insertion of IUCD During Cesarean Delivery Versus 6 Week Post-Cesarean Insertion

The aim of current study is to compare the rates of IUCD expulsion and complications in immediate post-placental insertion versus delayed IUCD insertion (6-weeks after cesarean delivery)

Intrauterine devices (IUDs) are among the most effective forms of contraception, offering greater than 99% efficacy per year of use and are completely reversible .

Post-placental intrauterine device (IUD) insertion is a safe, convenient, and effective option for postpartum contraception. "Post-placental" refers to insertion within 10-15 minutes of placental delivery, after vaginal or cesarean delivery.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18 -45
* Singleton pregnancy at ≥32 weeks gestation at time of enrollment
* Voluntarily requesting to IUD placement for postpartum contraception
* Able to give consent and agree to the terms of the study

Exclusion Criteria:

1. Uterine anomaly that preventing replacement of IUD.
2. Chorioamnionitis (such as prolonged rupture of membranes \>18 hours, prolonged labor \>24 hours, fever \>38C).
3. Puerperal sepsis and unresolved postpartum hemorrhage.
4. IUD allergy (copper).
5. Systemic lupus erythematosus with severe thrombocytopenia
Efﬁcacy and Safety of Weight-Based Insulin Titration Regimen in Hospitalized Patients With Type 2 Diabetes

The investigators propose to use a weight-based regimen consisting of basal-bolus insulin and preprandial rapid-acting insulin and to test its efficacy and safety in controlling blood glucose in hospitalized patients with type 2 diabetes.

Patients with type 2 diabetes are randomly assigned by computer-generated block randomization to receive either weight-based or glucose level-based titration regimen. All antidiabetic drugs are discontinued on admission.

Starting dose:

Total daily insulin is 0.4U/kg. Half is given as glargine and the remainder as aspart which is divided into three equal parts used for three pre-meal boluses.

Titration:

1. Weight-based insulin titration regimen:

   Glargine titration: 0.1U/kg per day when fasting blood glucose (FBG) is over 8.0 mmol/L.

   Aspart titration: total dose 0.1U/kg per day when next pre-meal blood glucose (BG) is over 8.0 mmol/L, which is divided into three equal parts adding to three pre-meal boluses.
2. Glucose level- based titration regimen:

Glargine titration: 4, 6, or 8 U when FBG is, respectively, within the following ranges: 8.0-8.9, 9.0-9.9, \>10.0 mmol/L.

Aspart titration: 1, 3, 5, 7 or 8 U when next pre-meal BG is, respectively, within the following ranges: 8.0-10.9, 11.0-13.9, 14.0-16.9, 17.0-19.9, \> 20 mmol/L.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 to 80 years with type 2 diabetes admitted to Endocrinology wards.

Exclusion Criteria:

* Patients with hepatic or renal dysfunction, cancer, or diabetic ketoacidosis;
* Patients who are pregnant or lactating.
Serp-1 for the Treatment of Acute Coronary Syndrome

Males and females aged 18-80 years who present with ACS (unstable angina and non ST-elevation MI) defined as one or more episodes of angina lasting at least 5 minutes in the last 24 hours before admission and greater than 0.05 mV of presumed new ST-segment depression in at least 2 contiguous ECG leads OR, angina and per confirmatory angiogram, has been scheduled for percutaneous coronary angioplasty. The primary objective of this study is to evaluate the safety of Serp-1 injection when administered in 3 daily doses to patients undergoing conventional therapy for Acute Coronary Syndrome (ACS) requiring early intervention.

A total of 72 subjects will be enrolled, separated into 3 dose groups and centrally randomized in a 3:1 ratio of Serp-1 injection to placebo control.Subjects will receive Serp-1 by intravenous (IV) bolus injection daily for 3 days, at dose levels of 5.0, 15, and 50 ug/kg/dose or placebo (0.9% normal saline) added to any prescribed therapy for ACS. Serp-1 will be administered as a single IV bolus injection. The initial IV bolus dose is administered immediately preceding the PCI procedure with subsequent doses administered 24 and 48 hours later.Subjects will be evaluated for adverse events, serum inflammatory markers and restenosis rates at 6 months post-dose.

Eligibility Criteria:
Inclusion Criteria:

* Established diagnosis of unstable angina or NSTEMI with one or more episodes of angina in the 24 hours before hospital admission
* Scheduled for PCI

Exclusion Criteria:

* CABG within 6 months
* Acute ST elevation, eligible for thrombolysis on initial examination
* Coronary lesions with total thrombotic occlusions
* Current immunosuppressant therapy
Wellness Intervention for Menstrual Mood Disorders

This study has been funded by National Institute of Mental Health (NIMH) to compare two behavioral interventions for Menstrual Mood Disorders, including premenstrual dysphoric disorder (PMDD). Both of these interventions will be run in a group format, meaning that you will be part of a group of other women who have a menstrual mood disorder. Both of these interventions will be run by experienced mental health professionals and both interventions have been shown to be effective in reducing mood symptoms, increasing a sense of well-being, and helping individuals cope with stress. While it is expected that both interventions to be associated with some benefit, this study is designed to see which is better for women with a menstrual mood disorder.


Eligibility Criteria:
Inclusion Criteria:

* Meets prospective criteria for a menstrual mood disorder, including PMDD
* Depression symptom severity and functional impairment based on prospective symptom ratings for 2-3 cycles using the Daily Record of Severity of Problems (DRSP)
* Clear remission of all symptoms during days 6-10
* 18 - 55 years of age
* Regular menstrual cycles
* Early life sexual or physical abuse (50% of sample) or no history of sexual or physical abuse (50% of sample)
* Absence of current PTSD symptoms using the 17-item PTSD checklist (PCL)
* 8th grade literacy level
* Ability to give informed consent

Exclusion Criteria:

* Current Axis I disorder or suicide ideation (histories of depression, anxiety, substance abuse, and eating disorders are allowed if in remission for \>2 years)
* Premenstrual exacerbation of chronic disorders
* In a current abusive relationship or residing with a former abuser
* A lifetime history of suicide attempt, or suicidal thoughts or gestures within 5 years of study enrollment
* Histories of bipolar or psychotic disorders
* Age \< 18 or \> 55 years
* Pregnancy or breastfeeding
* Use of psychotropic, hormonal or other agents that alter mood or biological mediators
* Current functional pain disorder
* A history of meditation practice (2+ times/week for 15+ min; some yoga allowed)
* Diabetes
* BMI \< 18.5
* Vigorous exercise
* Stage 2 Hypertension
* Any symptom item rated \>2 (moderate or higher) or a total score \> 24 on the PTSD checklist
Study of Desmoteplase (International Nonproprietary Name [INN]) in Acute Ischemic Stroke (DIAS-2)

The purpose of this study is to evaluate desmoteplase (which is a manufactured protein derived from the saliva of the vampire bat) in dissolving clots that are blocking the flow of blood through one (or more) of the blood vessels supplying the brain, thereby reopening the blocked blood vessel and allowing blood to flow again in individuals suffering from ischemic stroke.


Eligibility Criteria:
Inclusion Criteria:

* Eligible for study treatment within 3-9 hours after onset of stroke symptoms.
* Score of 4-24 on the NIHSS with clinical signs of hemispheric infarction (i.e. hemiparesis) suggestive of ischemic stroke.

Inclusion Criteria from diagnostic imaging screening:

* Distinct penumbra (at least 20%), measured by MRI (PWI/DWI) or perfusion CT, related to middle cerebral artery (MCA), anterior cerebral artery (ACA), or posterior cerebral artery (PCA) territory in a hemispheric distribution.

Exclusion Criteria:

* History or clinical presentation of intracranial hemorrhage (ICH), subarachnoid hemorrhage, arteriovenous malformation, aneurysm, or cerebral neoplasm.
* Rapidly improving neurological symptoms.
* Pre-stroke MRS score of \> 1 (including previous disability).
* Suspected acute vertebral or basilar artery occlusion.
* Current use of anticoagulants and a prolonged prothrombin time.
* Uncontrolled hypertension.
* Baseline hematocrit of \< 0.25.
* Baseline platelet count \< 100,000/mm3.
Psoriasis Longitudinal Assessment and Registry

The purpose of this study is to further evaluate the safety of infliximab, ustekinumab, and guselkumab in patients with plaque and other forms of psoriasis. The study also includes patients receiving other therapies, such as non-biologic and other biologic agents. The registry also evaluates patient and disease characteristics, including patient-reported assessment of psoriatic arthritis (PsA); and clinical and quality of life outcomes.

PSOLAR is an ongoing voluntary observational study in which infliximab-exposed patients, ustekinumab-exposed patients, and patients treated with other biologic and non-biologic standard of care therapies have been enrolled internationally and are followed for up to 8 years. Additionally, enrollment is opened to include at least 2000 guselkumab-exposed patients and up to 2000 patients exposed to IL-17 inhibitors. The Registry does not require any study-specific testing, but may capture information collected as part of normal routine care. Patient information is collected at the enrollment visit and about every 6 months thereafter. At enrollment, information on demographics (e.g. gender, and race), medical history and family medical history, details of past and current psoriasis treatments, and current psoriasis medications is collected. At enrollment and each follow-up visit, data are collected regarding physical examination, clinical disease status, Quality of Life assessments, current psoriasis medications, patient-reported PsA assessments, and adverse events. No study agents are administered for the purpose of this registry; all patients receive standard of care treatment as prescribed by the patient's physician.

Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of psoriasis
* Incident or prevalent users of Tremfya or an IL-17 inhibitor (eg, secukinumab, ixekizumab, brodalumab, bimekizumab) at the time of their enrollment. Incident users are defined as those participants starting treatment within 30 days before or after the enrollment visit and prevalent users are defined as those who are on treatment greater than 30 days prior to the enrollment visit
* Ability to understand and sign an informed consent form
* Are willing to participate in regular follow-up visits

Exclusion Criteria:

* Refuse to consent or are unwilling to respond to requests for long term information within the required time frame
* Are participating or have already planned to participate in a clinical trial with non-marketed investigational agents or are participating in a Janssen-sponsored clinical trial with marketed agents
Medical Record Review of Hypohidrotic Ectodermal Dysplasia Clinical Phenotype

This study is being done to collect information about people who have or may have Hypohidrotic Ectodermal Dysplasia (HED) or X-linked Hypohidrotic Ectodermal Dysplasia (XLHED). This study will allow Edimer Pharmaceuticals to know more about HED/XLHED so that hopefully the investigators can develop a drug to treat this condition. In this study Edimer will retrospectively review and abstract (summarize) medical records of people that have or may have HED/XLHED in order to further understand the natural history and disease characteristics.


Eligibility Criteria:
Inclusion Criteria:

-Males or females with:

1. the clinical characteristics of HED, including at least two of the following characteristics: a history of decreased sweating;abnormal teeth (fewer permanent teeth, teeth are smaller than average and often have conical crowns);sparseness of scalp and body hair.

   -OR-
2. genetically confirmed HED or XLHED;