cyrilzakka/clinical-trials huggingface dataset:
Phase III Long-Term Extension Study With Dexpramipexole

The goal of this clinical trial\] is to evaluate the long term safety of dexpramipexole treatment in participants with severe asthma, aged ≥12 years, on Global Initiative for Asthma (GINA) 2021 \[GINA, 2021\] Step 4 or 5 therapy and who completed either of the Phase III studies EXHALE-2 or EXHALE-3.


Eligibility Criteria:
Inclusion Criteria:

1. Participants who completed the double-blind study intervention treatment period during either of the Phase III studies EXHALE-2 or EXHALE-3.
2. Participants capable of giving signed informed consent/assent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
3. Negative urine pregnancy test for women of childbearing potential (WOCBP; after menarche) at the Baseline Visit/Day 1.
4. WOCBP (after menarche) must use either of the following methods of birth control, from the Baseline Visit/Day 1 through the End of Study Visit:

   1. A highly effective form of birth control (confirmed by the investigator). Highly effective forms of birth control include: true sexual abstinence, a vasectomized sexual partner, Implanon, female sterilization by tubal occlusion, any effective intrauterine device (IUD), IUD/intrauterine system, levonorgestrel intrauterine system, or oral contraceptive. -OR-
   2. Two protocol acceptable methods of contraception in tandem. Women not of childbearing potential are defined as women who are either permanently sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who are postmenopausal. Women will be considered postmenopausal if they have been amenorrheic for ≥12 months prior to the planned date of the Baseline Visit/Day 1 without an alternative medical cause. The following age specific requirements apply:
   3. Women \<50 years old will be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatment and follicle stimulating hormone levels in the postmenopausal range.
   4. Women ≥50 years old will be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatment.

Exclusion Criteria:

1. Clinically significant change in health status during either of the Phase III studies EXHALE-2 or EXHALE-3 which in the opinion of the investigator would make the participant unsuitable for participation in this study.
2. Participants with allergy/intolerance to dexpramipexole or any of its excipients.
3. Participants who met permanent discontinuation criteria or permanently discontinued study treatment for any reason in either of the Phase III studies EXHALE-2 or EXHALE-3..
4. Treatment with selected drugs known to have a substantial risk of neutropenia in the past 30 days.
5. Pregnant or breastfeeding women.
6. Males who are unwilling to use an acceptable method of birth control during the entire study period (ie, condom with spermicide).
Review of Enteral Formulas in Children

Retrospective review of nutrition enteral formula data documented in medical records.

This is a retrospective review to assess nutrition (calorie and protein) intake of enteral formula data documented in medical records of patients that consumed enteral tube feeding formulas at home.

Eligibility Criteria:
Inclusion Criteria:

* Minimum 12 months enteral feeding
* History of enteral feeding with intact or semi-elemental formula

Exclusion Criteria:

* Medical records lacking enteral nutrition feeding use
Novel MRI Sequence- MR Fingerprinting

Magnetic Resonance Imaging (MRI) has become one of most important medical imaging tools over the past 30 years because it is non-invasive, requires no ionizing radiation, and provides exquisite images of soft tissues and anatomic structures with many tissue/disease specific contrasts. While MRI has served the community well for many years, it is increasingly clear that it also has significant limitations.

One of the principle limitations is the lack of quantitative information for tissue/structure characterization. The current paradigm of MRI is to use a set of scanner settings to generate an image "weighted" by a specific MR contrast mechanism (physical parameter), where it is hoped that variations in the parameter will be accentuated. However, without quantitative knowledge of the parameters, the final image contrast may depend on many factors, which complicates image interpretation and diagnostic performance. Quantitative measurement can provide a great deal of information about tissue properties and pathological conditions, since these parameters ultimately determine the contrast that is observed in conventional images.

The purpose of this study is to evaluate novel quantitative MRI techniques in clinical studies to determine whether they can provide better, faster and more useful information for clinical diagnosis. In this study, the investigators propose to apply MR Fingerprinting and evaluate its performance for different diseases. These include, but are not limited to, diseases in the liver, kidney, cardiac, pancreas etc. The investigators hypothesize that the quantitative MR Fingerprinting imaging technique will lead to improved tissue characterization and diagnosis.

Eligibility Criteria:
Inclusion Criteria:

* The study will include English-speaking patients that are already scheduled to undergo a clinical MRI for diagnostic purposes.

Exclusion Criteria:

* Pregnant women will be excluded.
* Women will be excluded from the healthy volunteers, due to a lack of funding for pregnancy testing. Funding for this will be considered for the future.
Short-term Effects of Transdermal Estradiol on Female COVID-19 Patients

The goal of this randomized placebo-controlled study is to investigate the short-term effects of transdermal estrogen therapy on postmenopausal women with COVID-19 disease.

The main question\[s\] it aims to answer are:

* the clinical outcomes with adding estrogen treatment to conventional therapy of Covid-19 disease
* the biochemical outcomes with adding estrogen treatment to conventional therapy of Covid-19 disease

All participants received favipiravir for a week according to the national guidelines published by the Health Ministry of Turkish Republic at that time.

As an intervention, transdermal estradiol patch (7.8 mg patch/week) was applied for 14 days on the upper buttock of the patients in experimental arm. As a placebo, hydrogel patch (adhesive hydrogel patch/week) was applied to the female patients for 14 days.

Researchers compared experimental and control groups to see if the impact of adding estrogen on the clinical course of Covid-19 disease

The risk of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, morbidity and mortality from Covid-19 disease were higher among men compared to women. This is caused by the differences in immunological response and viral pathogenesis between men and women. It is theoretically assumed that estrogen has a positive impact on female COVID-19 patients. In this randomized placebo-controlled study, we aimed to investigate the short-term effects of transdermal estrogen therapy on postmenopausal women with COVID-19 disease. Female patients diagnosed with Covid-19 disease were examined and only postmenopausal women were included into the study. The COVID-19 diagnosis was made with a positive reverse transcription-polymerase chain reaction (RT-PCR) test given with nasal and oral swabs. All participants received favipiravir for a week according to the national guidelines published by the Health Ministry of Turkish Republic at that time.

As an intervention, transdermal estradiol patch (7.8 mg patch/week) was applied for 14 days on the upper buttock of the patients in experimental arm. As a placebo, hydrogel patch (adhesive hydrogel patch/week) was applied to the female patients for 14 days.

Our primary outcome was to achieve better clinical and biochemical outcomes with adding estrogen treatment to conventional therapy of Covid-19 disease. The epidemiological and clinical data, the results of biochemical analysis, the information regarding the treatment and outcomes and serum estradiol levels were determined.

Eligibility Criteria:
Inclusion Criteria:

* Female patients diagnosed with Covid-19 disease
* Postmenopausal women (who had 12 months of amenorrhea after their final menstrual period)
* Positive reverse transcription-polymerase chain reaction (RT-PCR) test given with nasal and oral swabs

Exclusion Criteria:

* Negative RT-PCR test
* Female patients at reproductive stage
Over-night Effect of Dietary Fiber on Glucose Metabolism and Satiety

The experimental model is a semi-acute, over-night, study where the purpose is to evaluate food factors related to colonially derived regulation and satiety in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Normal fasting blood glucose
* BMI 19-25 kg/m2

Exclusion Criteria:

* Gastrointestinal diseases
* Food allergies e.g. lactose-, gluten intolerance
* Metabolic disorder e.g. diabetes
* Tobacco/snuff users
* No antibiotic or probiotic intake 2 weeks prior and during study.
* Vegetarians
A Study of DWJ1248 in Prevention of COVID-19 Infection After the Exposure of SARS-COV-2

To evaluate the prevention of SARS-COV-2 infection after administration of DWJ1248 in person who contact from COVID-19 confirmed patient compared to the placebo.


Eligibility Criteria:
Inclusion Criteria:

* Adults over the age of 19 as of the signed date in written consent
* Subjects in self-quarantine who contact from COVID-19 confirmed patient
* Subjects who have COVID-19 negative RT-PCR result
* Subjects with no symptoms of COVID-19

Exclusion Criteria:

* Subjects who cannot orally administer the investigational products
* Subjects who need administration of immunosuppressants
* Subjects who are allergic or sensitive to investigational products or its ingredients
* Subjects who have a history of drug and/or alcohol abuse within 12 months before screening
* Subjects who have been identified with uncontrolled concomitant diseases or conditions, including significant mental illness and social conditions, that may affect compliance with clinical trial procedures according to the determination of the investigators
Development of a Reference Interval Database With the NeuroCatch™ Platform

The NeuroCatch Platform™, an investigational medical device system developed by NeuroCatch Inc., consists of software and hardware that captures brain health information. The platform intends to provide a quick, portable and easy to use solution for the acquisition, display, analysis, storage, reporting and management of electroencephalograph (EEG) and event-related potential (ERP; brain response to a stimulus) information.

The purpose of the study is to understand how the brain responds to sounds and words, and how this response varies between individuals of different age groups. Interindividual variation reflects the many different factors which cause results to vary from one individual to another within a population. The current clinical study aims to establish a reference interval database of ERPs. These reference intervals will characterize the expected range of interindividual variability between groups. Reference interval databases provide a tool for comparing the results from one individual with those from other members of the same age group.


Eligibility Criteria:
Inclusion Criteria:

1. Any sex, at least 8 years of age or older
2. Able to understand the informed consent/assent form, study procedures and willing to participate in study
3. Able to remain seated and focused for 6 minutes
4. Normal hearing capabilities

Exclusion Criteria:

1. Clinically documented hearing issues (e.g. tinnitus, in-ear hearing problems or punctured ear drum)
2. Implanted pacemaker or implanted electrical stimulators
3. Metal or plastic implants in skull
4. Exposed to an investigational drug or device 30 days prior to start in this study, or concurrent or planned use of investigational drug or device while enrolled in this study
5. Not proficient in English language
6. Previous exposure to the NeuroCatch™ Platform audio sequences in the last 6 months
7. If female and of child-bearing potential: pregnant, suspected or planning to become pregnant or breast-feeding
8. History of seizures
9. Allergy to rubbing alcohol or EEG gel
10. Unhealthy scalp (apparent open wounds and/or bruised or weakened skin)
Effects of Timing of Cord Clamping on Serum Calcium Levels in Neonates

Title: Effect of timing of cord clamping of serum calcium levels in neonates Background: Hypocalcemia is a common metabolic problem in neonatal period. Most cases of hypocalcemia are asymptomatic however, the symptomatic cases require prompt management.

Objective: The objective is to determine the effects of early and delayed cord on serum calcium level in neonates Study Design: Randomized Controlled Trial

Place and Duration of Study: PEMH Rawalpindi and CMH Rawalpindi from January 2024 to July 2024.

Patients and Methods: Total sample size of 200 neonates will be included in the study divided into four groups with cord clamping at 15s, 30s, 60s, 120s each group will have a total of 50 neonates. Blood sampling for CBC / CRP / S. Electrolytes (Na, K, Total Ca, Ionized Ca, Mg), S Calcitonin, ABGs (HCO3 Levels) samples will be collected at 6 hours of life.

* Inclusion Criteria: Neonates born at gestational age 37 weeks to 41 weeks with no maternal complication. Parents who give consent for inclusion in the study
* Exclusion Criteria: Mothers with evidence of clinical disease (diabetes, preeclampsia, hypertension). Babies with congenital malformations and intrauterine growth restriction.

Expected Results: Research data on serum Calcium levels in neonates have shown no correlation to timing of cord clamping. Same results are expected in this study.

Eligibility Criteria:
Inclusion Criteria:

* Neonates born at gestational age 37 weeks to 41 weeks with no maternal complication. Parents who give consent for inclusion in the study

Exclusion Criteria:

* Mothers with evidence of clinical disease (diabetes, preeclampsia, hypertension). Babies with congenital malformations and intrauterine growth restriction.
Celecoxib Versus Hyoscine Butyl-bromide in Reducing Pain Associated With IUD.

Many oral analgesic drugs such as the nonsteroidal anti-inflammatory drug (NSAID) are used to relieve pain from gynaecological procedures and dysmenorrhea. Hyoscine-N-butyl bromide, an antispasmodic drug is commonly used for relief of smooth muscle spasms and can be used to alleviate genito-urinary spasm. Some studies reported hyoscine couldn't relieve pain in minor gynaecological procedures. So the efficacy of Hyoscine-N-butyl bromide use is still controversial, and no previous studies investigated its effectiveness for pain relief in IUD insertion procedure.

The study objective is to compare the effectiveness and side effects of oral Celecoxib 200mg versus oral hyoscine butyl bromide 10 mg in reducing pain associated with IUD insertion. the study is an attempt to find the most effective drug with the least possible side effects to be used before IUD insertion.

Eligibility Criteria:
Inclusion Criteria:

* Non-pregnant nulliparous and parous menstruating women.
* Women who Did not receive any analgesics or misoprostol in the 24 hours prior to insertion.
* Presenting for insertion of CuT380A intrauterine device.
* the absence of contraindication for IUD insertion including positive cultures for gonorrhoea or chlamydia
* the absence of sedative or long-acting narcotics use 48 h before IUD insertion
* No history of severe mental stress in the past two months.

Exclusion Criteria:

* • Allergy to HYOSCINE BUTYLBROMIDE or celecoxib or contraindication to it as paralytic ileus, myasthenia gravis, pyloric stenosis and narrow-angle glaucoma.

  * Women who had been pregnant within the previous four weeks.
  * Women presenting for IUD removal and reinsertion
  * Any uterine abnormalities distorted uterine cavity as congenital anomalies, endometrial lesions, adenomyosis, and submucous myoma.
  * Enrollment in another study.
  * A psychological or neurological disorder associated with altered pain sensation.
  * a history of dysmenorrhea
  * a contraindication for IUD use such as a gynaecological malignancy, pelvic inflammatory disease or undiagnosed abnormal vaginal bleeding.
A Randomized Trial to Assess the Role of Imaging During Follow Up After Radical Surgery of High Risk Melanoma

It is not known whether radiological assessments during follow up after surgery for high risk melanoma improve survival. Since radiological examinations are resource demanding, could inflict worry and cause irradiation exposure it is an important question to address. With the introduction of effective medical treatments for malignant melanoma patients, there is a tendency to introduce radiological assessments despite the lack of evidence.

The patients are randomized 1:1 to routine follow up for 3 years with regular doctors´ appointments according to national guidelines and the same follow up but with the addition of whole body CT or Positron Emission Tomography (PET) scans and blood tests. An interim analysis will be conducted when 1000 patients have been included.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age.
* Radical surgery for Cutaneous Malignant Melanoma (CMM) stage IIb-c and III.
* Sufficient renal function for i.v. contrast scannings.

Exclusion Criteria:

* The patient is assessed as unfit to receive treatment in the case of recurrence.
* Life-expectancy less than 2 years due to concurrent disease (e.g., cardiac disease, terminal multiple sclerosis, liver cirrhosis).
* Inability to provide informed consent or refusal to do so.
* Inability to comply with the control or intense follow-up program.
* Participation in other clinical trials interfering with the control-program.
* Existing or previous malignancies within the past 5 years (except for in situ breast and cervical cancer, melanoma in situ and non-melanoma skin cancer).
* Pregnancy or currently planned pregnancy.
Homburg Cream & Sugar Study

The purpose of this study is to prospectivly analyze the correlation of triglyceride tolerance and glucose tolerance with cardiovascular morbidity and mortality in patients with stable coronary artery disease within 18 months and to determine, whether measurement of triglyceride tolerance can discriminate patients at risk for cardiovascular events.


Eligibility Criteria:
Inclusion Criteria:

* Stable CAD

Exclusion Criteria:

* Acute Coronary Syndrom
* Relevant Arrhythmias
* Severe valvular heart disease
* Decompensated heart failure
* Severe inflammtory disease (infectious, rheumatoid)
* Metabolic diseases (e.g. thyroid)
* Inability to swallow
* Liver or kidney failure
* Lactose intolerance
* Fat intolerance (e.g. chronic pancreatitis, gall stones)
* Malignant Disease
* Psychiatric Diseases (including alcohol / drug abuse)
* Pregnancy
SmartPICC-1 Feasibility Study Technical Feasibility Study

The primary objective of this study is to evaluate the safety and technical feasibility of the Piccolo Medical SmartPICC System, indicated for guidance and positioning of commercially available central venous catheters, for PICC placement in adults.

The primary objective of this study is to evaluate the safety and technical feasibility of the Piccolo Medical SmartPICC System for PICC placement in adults. The SmartPICC system is indicated for guidance and positioning of commercially available central venous catheters. In this prospective, single arm (non-randomized), safety and technical feasibility study, adult volunteers who meet the protocol entry criteria and are scheduled to undergo PICC placement will be recruited. Immediately following placement with use of the SmartPICC System, subjects will undergo an assessment of the PICC placement site, as technical feasibility will be evaluated as the ability of the SmartPICC System to provide venous navigation for PICC placement in the lower superior vena cava (L-SVC), cavoatrial junction (CAJ), or proximal right atrium (RA) as confirmed by radiologic review. Safety will be evaluated as freedom from serious adverse events (SAEs) directly attributable to the SmartPICC system. Subjects will be evaluated at 12-24 hours post-placement to ensure safety, in addition to a review of subject medical records 7 days post PICC placement.

Eligibility Criteria:
Inclusion Criteria:

* Subject has provided written informed consent, including authorization to release health information
* Subject between 22-85 years of age at the time of consent
* Subject is scheduled for PICC placement
* Subject understands and is able and willing to comply with the study requirements
* Subject has provided a negative pregnancy test (if subject is a woman of childbearing potential (WOCBP))

Exclusion Criteria:

* Contraindicated for PICC
* Subject is enrolled in another clinical study where the safety profile is not yet established or may otherwise confound the SmartPICC-1 Study results
* Subject is deemed ineligible for the study in the opinion of the investigator, physician, and/or PICC nurse
* Subject has single ventricle anatomy
* Subject has a BMI that, in the opinion of the investigator, physician, and/or PICC nurse, would interfere with successful PICC placement
* Subjects with known stenosis of the upper arm and right-side veins that may prevent successful PICC placement
* Subject has mechanical circulatory support device (e.g. ECMO, VAD)
* Subject is pregnant
* Subject has or is suspected to have COVID-19