cyrilzakka/clinical-trials huggingface dataset:
Reduction of Myopotential Interference With Smart Pass in S-ICD Patients

This study is enrolling participants who are already implanted with a S-ICD device ( subcutaneous ICD), and are undergoing a routine outpatient clinic follow up appointment to have their S-ICD checked. The aim of the study is to see if a feature in the device can recognize muscle movement and differentiate movement from irregular heart signals. The study involves doing some simple arm exercises while collecting device data, both with this feature turn on and then with it turned off. Participants will be randomized to either have the feature turned on or off initially then it will be programmed the alternative way and the same exercise testing will be repeated. The study will involve just one visit.

This study is enrolling participants who are already implanted with a S-ICD device ( subcutaneous ICD), and are undergoing a routine outpatient clinic follow up appointment to have their S-ICD checked. The aim of the study is to see if a feature in the device can recognize muscle movement and differentiate movement from irregular heart signals. The study involves doing some simple arm exercises while collecting device data, both with this feature turn on and then with it turned off. Participants will be randomized to either have the feature turned on or off initially, then it will be programmed the alternative way and the same exercise testing will be repeated. The study will involve just one visit. Following this visit study participation is complete.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Implanted EMBLEM S-ICD (Model A 209 and Model A 219, Boston Scientific, St Paul, MN, USA)

Exclusion Criteria:

* Less than 18 years of age
* Hemodynamically unstable
* Inability to preform TET due to orthopedic issues or cognitive impairment
Sex Differences in Gene Expression in Human Adipose Tissue

This project was created to assess sex differences in adipose tissue gene expression in different locations in the body. The primary objectives are to understand:

1. The mechanisms of differential body fat distribution in men and women
2. How body fat distribution is affected by reproductive hormones
3. The mechanisms linking fat distribution to health risks such as diabetes


Eligibility Criteria:
Inclusion Criteria:

* Caucasian men and women 20-35 years of age
* Lean (BMI less than 25)
* Obese (BMI 30-35)

Exclusion Criteria:

* Hormonal birth control
* Pregnancy
* Smokers
* History of diabetes, kidney, liver or thyroid disease
* History of cancer
Metformin to Treat Corticosteroids-induced Hyperglycemia

Antenatal corticosteroids, particularly, betamethasone is routinely administered to pregnant women at risk for preterm delivery to improve neonatal outcomes.

Although antenatal betamethasone was shown to induce both maternal hyperglycemia and neonatal hypoglycemia, to date, there is insufficient data to establish whether treatment for maternal hyperglycemia, particularly, metformin, will decrease the risk for neonatal hypoglycemia, particularly of preterm neonates.

In the present study the investigators will examine the effect of treatment with metformin on maternal glycemic control and hypoglycemia in preterm neonates following maternal betamethasone treatment.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women receiving betamethasone from 24 to 36.5 gestational weeks
* Before or within 24 hours following the first dose of betamethasone
* ≥18 years old

Exclusion Criteria:

* Women with pre-gestational and gestational diabetes mellitus (GDM)
* Known allergic sensitivity to metformin
* Known chronic heart failure
* Known chronic renal failure
* Refuse to participate
* Refuse to perform glucose challenge test/glucose tolerance test later on
Dose-Response Study of Recombinant Factor VIII Manufactured Protein-Free (rAHF-PFM) in Patients With Hemophilia A

The purpose of this study is to determine the effect of 3 doses of ADVATE rAHF-PFM on initial recovery (% increase \[IU/dL\] per IU/kg infused) and major single-infusion pharmacokinetic parameters. The 3 doses are 15, 30, and 50 IU/kg. Prior to each infusion, subjects will not have received treatment with a factor VIII concentrate for at least 3 days. Blood samples will be drawn within 30 minutes pre-infusion and at 0.25, 0.5, 1, 3, 6, 9, 24, 28, 32 and 48 hours post-infusion. A washout period of at least 3 days, but no more than 30 days between the last blood draw and the next infusion will be observed. During participation, subjects will maintain their preexisting treatment regimens with ADVATE rAHF-PFM or other factor VIII concentrate.

A secondary objective is to investigate the relationship between pharmacokinetic parameters at each dose level and the levels of von Willebrand factor ristocetin cofactor activity and von Willebrand factor antigen at baseline.


Eligibility Criteria:
Inclusion Criteria:

* The subject has severe hemophilia A as defined by a baseline factor VIII activity \<1% of normal; tested at screening. (A minimum washout period of 3 days is required before the blood sample can be drawn to determine baseline factor VIII levels.)
* The subject has a documented history of at least 150 exposure days to factor VIII concentrates (either plasma-derived or recombinant).
* The subject is within 12 to 65 years of age.
* The subject has a Karnofsky performance score \>60.
* The subject is human immunodeficiency virus negative (HIV-) or HIV+ with CD4 count \>=400 cells/mm3 (CD4 count determined at screening, if necessary).
* The subject or subject´s legally authorized representative has provided written informed consent.

Exclusion Criteria:

* The subject has a known hypersensitivity to mouse or hamster proteins or to factor VIII concentrates.
* The subject has a history of factor VIII inhibitors with titer \>=0.8 BU (Bethesda Assay) or \>=0.4 BU (Nijmegen modification of the Bethesda Assay) any time prior to screening.
* The subject has a detectable factor VIII inhibitor at screening, \>=0.4 BU (Nijmegen modification of the Bethesda Assay), in the Baxter central laboratory.
* The subject has severe chronic liver disease as evidenced by, but not limited to, any of the following: International Normalized Ratio (INR) \>1.4, hypoalbuminemia, portal vein hypertension including presence of otherwise unexplained splenomegaly and history of esophageal varices.
* The subject has been diagnosed with an inherited or acquired hemostatic defect other than hemophilia A (e.g. qualitative platelet defect or von Willebrand´s Disease).
* The subject has participated in another investigational study within 30 days of enrollment.
* The subject´s clinical condition may require a major or moderate surgery (estimated blood loss \>500 mL) during the period of participation in the study.
The Effect of Floorball on Health and Performance in Subjects With Lifestyle Diseases

To investigate the effect of floorball on health and performance in subjects with either type 2 diabetes or cardiovascular diseases.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with type 2 diabetes
* Diagnosed with a cardiovascular disease (bp \>140/90mmHg)
* Physical activity \<2 hours pr. week.
* Not participating in any regular physical activity the last 2 years

Exclusion Criteria:

* age \<18 years
* Injuries that prevent the subject from playing floorball
* Type 1 diabetics
* Alcohol \>14 units pr. week.
* Pregnancy
* Participation in other scientific studies
* Abuse of illegal drugs
* other known serious diseases
A Study of AP-CD/LD in Fluctuating Parkinson's Disease Patients Who Completed IN 11 004

The purpose of this study is to allow evaluation of long-term clinical effect and safety outcome of treatment with AP-CD/LD, as well as to allow patients to benefit from extended treatment duration with AP-CD/LD after they have successfully completed the Phase 3 core study IN 11 004 ('core study', a phase III, multicenter, randomized, double-blind, double-dummy, active-controlled Phase 3 study to assess the safety and efficacy of AP CD/LD versus IR CD/LD in fluctuating PD patients).

This will be a multi-center, global, open-label study in adult suffering from fluctuating Parkinson's disease subjects who have successfully completed the core study IN 11 004.

After signing informed consent and meeting inclusion/exclusion criteria, eligible subjects will be enrolled into a 12-month open-label extension and receive the AP-CD/LD as needed.

Efficacy and safety will be assessed throughout the study period.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects who successfully completed the core study IN 11 004 and, in the opinion of the Investigator, would benefit from long-term treatment with AP-CD/LD
2. Continue to carry the diagnosis of Parkinson's disease consistent with UK brain bank criteria
3. Has a good response to Levodopa in the opinion of the investigator
4. Subjects able and willing to give written (signed and dated) informed consent to participate in the study

Exclusion Criteria:

1. Participation in another clinical trial other than IN 11 004 and receipt of an investigational medication other than that administered in the context of IN 11 004 within 28 days prior to the planned start of treatment
2. Previous or planned neurosurgical or Duodopa treatment for Parkinson's Disease (e.g., procedures including ablation or deep brain stimulation)
3. Non-selective monoamine oxidase (MAO) inhibitors within 28 days prior to Baseline Visit or planned administration during study participation
4. If, in the opinion of the Investigator, subject should not participate in the study
5. Women who are pregnant or nursing. Women of childbearing potential who are not willing to use a medically acceptable method of contraception.
A Study of Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Treated With Lisocabtagene Maraleucel in the Post-Marketing Setting

The purpose of this study is to characterize the long-term safety of lisocabtagene maraleucel (liso-cel), focusing on patients treated in the chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) indication, and will be part of post-marketing liso-cel pharmacovigilance activities


Eligibility Criteria:
Inclusion Criteria:

• Participants must have been treated in the post-marketing setting with ≥1 infusion of lisocabtagene maraleucel used for the treatment of relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) within the approved indication and dosage per the United States Prescribing Information (USPI) and product specifications approved for commercial release in the USA

Exclusion Criteria:

* Participants known to be participating in investigational studies at the time of lisocabtagene maraleucel infusion
* Patients treated with non-conforming CAR T-cell product
Internet-Based CBT for Children With Anxiety Disorders: Implementation in Clinical Settings

The primary objective of this study is to test the effectiveness of internet-delivered and therapist-guided internet-based cognitive behavior therapy (ICBT) for children with anxiety disorders (including social anxiety disorder, separation anxiety disorder, generalized anxiety disorder, panic disorder and specific phobia) in a randomized trial where participants will be allocated to either ICBT or to a supportive control condition. Non-responders (defined as those participants who still uphold their primary anxiety disorder after the ICBT treatment) will be offered traditional (face-to-face) CBT. Follow-ups are conducted at 3 and 12 months after treatment completion.


Eligibility Criteria:
Inclusion Criteria:

* A primary diagnosis of any of the following anxiety disorders, as defined by DSM-V (social anxiety disorder, separation anxiety disorder, generalized anxiety disorder, panic disorder or specific phobia)
* Age between 8 and 12 years
* Ability to read and write Swedish
* Daily access to the internet
* A parent that is able to co-participate in the treatment
* Participants on psychotropic medication must have been on a stable dose for the last 6 weeks prior to baseline assessment

Exclusion Criteria:

* Diagnosed with autism spectrum disorder, psychosis, bipolar disorder or severe eating disorder
* Present risk of suicide
* Ongoing substance dependence
* Completed CBT for any anxiety disorder within the last 6 months (defined as at least 5 sessions of CBT including in vivo exposure sessions)
Safety, Pharmacokinetics and Efficacy of PP405 in Adults With AGA

The study is a two part study, designed to validate safety results from the Phase 1 PP405-001 trial while also characterizing longer term safety and PK. Part 1 of the trial is the randomized controlled portion that will focus on safety and PK following 28 days of blinded treatment administration with either PP405 or vehicle control. Part 2 of the trial is an open-label extension that will validate the results of Part 1 with 3 months of treatment administration.

Safety, Pharmacokinetics, and Efficacy Study of PP405 in subjects with Androgenetic Alopecia.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects aged 18 to 55 years.
2. Able and willing to provide written informed consent.
3. Males must have an AGA modified Norwood-Hamilton Classification score of Type III vertex, Type IV or Type V. Females must have a Savin classification score of I-2, I-3 or I-4.
4. Agree to comply with protocol procedures

Exclusion Criteria:

1. Concomitant diagnosis of non-AGA forms of alopecia.
2. Use of other hair loss treatments within periods specified in protocol.
3. Use of excluded medications as specified in protocol.
4. Diagnosis of other medical conditions as specified in protocol.
5. Any disease or medical condition that, in the opinion of the Investigator, would prevent the subject from participating in the study or might confound study results.
Prospective Investigation of Pulmonary Embolism Diagnosis (PIOPED II)

To determine the value of contrast enhanced spiral computed tomography (spiral CT) for the diagnosis of acute pulmonary embolism (PE).

BACKGROUND:

Approximately 600,000 Americans sustain pulmonary embolism each year; one-third of these episodes are fatal. Unfortunately, pulmonary embolism is underdiagnosed and, therefore, under-treated. A substantial body of evidence suggests that the diagnosis of pulmonary embolism is not made in the majority of patients in whom it causes or contributes to death.

In the main, there are two explanations for the failure to diagnose pulmonary embolism: pulmonary embolism may be clinically silent, and there is no definitive, noninvasive diagnostic test. Indeed, ventilation perfusion lung scans are nondiagnostic in the majority of patients with suspected acute pulmonary embolism. Pulmonary angiography may be used to establish a diagnosis in such patients, but it is underutilized because of a mortality risk around 1 percent.

Recently, relatively small studies have suggested that contrast enhanced spiral computed tomography (CT) scanning is a useful diagnostic test for pulmonary embolism, with sensitivity as high as 80 percent and specificity as high as 95 percent. Spiral CT is widely available and much less invasive than pulmonary angiography. If spiral CT could be established as a useful diagnostic test, pulmonary embolism would be diagnosed more effectively and more patients would receive proper treatment.

DESIGN NARRATIVE:

The study evaluates the role of spiral CT scan in the diagnosis of PE by comparison with a composite reference test, including pulmonary angiography, V/Q lung scan in patients without prior PE and compression ultrasound of the lower extremities in patients with no prior deep venous thrombosis (DVT).

Eligibility Criteria:
\> 18% normal kidney function, no dye allergies, suspected of acute pulmonary embolism
Projected Peripheral Defocus Using a Wearable Device

Acucela Inc. intends to develop a medical device to significantly halt or reverse myopic progression, which is a significant public health concern across the world, especially in Asian demographics. Acucela is working towards a spectacle-like device (eSPECs), which will have a clear zone for unimpeded central visual tasks and a periphery that provides defocus in order to alter retinal physiology leading to myopia regulation. This study will establish the changes seen during a proof-of-concept that projected defocus in the periphery utilizing a wearable device will stimulate physiological changes similar to those in the literature.


Eligibility Criteria:
Inclusion Criteria:

* Spherical equivalent +2.00 to -4.00 diopters
* Refractive cylinder ≤ 0.75 diopters
* Visual acuity 20/20 -3 or better

Exclusion Criteria:

* Pregnant or lactating
* Active ocular infection
* History of dry eye, strabismus, or amblyopia
* Previous or planned ocular surgery
* Use of medication known to affect vision or accommodation
Specific Modified Exercise Program for Low Back Pain in Racketlon Players

To compare the effects of conventional exercise protocol and specific modified exercise program to prevent low back pain in racketlon players.

Racketlon is a combination sport in which competitors play a sequence of the four most popular racket sports: Table Tennis, Badminton, squash and tennis. Squash (racquet sport) is an intermittent high-intensity competitive racquet sport that requires quick movements as maintaining control over the placement of the ball with the greatest spatial awareness that is played globally through racquet sports are enjoyed throughout the world and are increasing in their popularity. Since this game encumbers a high level of fitness from the players, who are usually active for the majority of the playing time. Squash players are physically challenged as they are engaged in continuous repetitive training and frequent participation in game to improve their fitness and skills.

The purpose of this study is to find the effects of modified exercise program on LBP in racketlon players. The modified exercise program is a 5-Week Linear Periodization Program, which had effects on Maximal Strength and Speed on elite squash players. This study will find whether this 5-week linear periodization program has an effect to prevent low back pain in racketlon players.

Eligibility Criteria:
Inclusion Criteria:

* Active Male Racketlon player involved in sport activities for at least 3 times per week
* Age between 20-30 years.
* Players having ≥ 2 episodes of mechanical low back pain in past 6 months.

Exclusion Criteria:

Any upper and lower limb injury.

* History of metabolic diseases.
* History of recent fractures.
* History of spinal radiculopathy
A Phase 1 Crossover Study of Blood Pressure and Heart Rate Response

This is a randomized, double-blinded, placebo-controlled, crossover study to evaluate the pressor effects of pseudoephedrine when administered with TR-701 FA in healthy adult volunteers.

Eligible subjects will be randomized to 1 of 2 possible treatment sequences (N=9 per sequence) on Study Day 1. Subjects will receive oral 200 mg TR 701 FA or Placebo for TR 701 FA once daily for 5 days during each treatment period, with a 2 day washout between periods (72 hours between doses). On Study Day 5 of each treatment period, subjects will also receive oral 60 mg PSE.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects between 18 and 45 years of age, inclusive
* Healthy males and females with no clinically significant abnormalities identified by a detailed medical history
* Body mass index ≥ 19.0 kg/m2 and ≤ 31.0 kg/m2

Exclusion Criteria:

* Systolic blood pressure \> 130 mmHg or \< 90 mmHg measured after 10 minutes supine at the Screening Visit and Study Day 1
* Diastolic blood pressure \> 90 mmHg or \< 60 mmHg measured after 10 minutes supine at the Screening Visit and Study Day 1
* Heart rate \> 90 bpm or \< 50 bpm measured after 10 minutes supine at the Screening Visit and Study Day
* Known allergy or hypersensitivity to PSE
Hemostatic and Analgesic Effect of Gel Foam and Gauze With Bosmin After Anal Surgery

To evaluate the hemostatic and analgesic effect of using gauze with Bosmin or Gelfoam after anal surgery.

Hemorrhoidectomy and fistulotomy these two types of anal surgery are common surgeries in colon and rectal surgery division in Shuang Ho hospital. For these patients underwent surgical treatment, some surgeons used gauze with Bosmin for hemostasis and analgesia after surgery, and other surgeons used Gelfoam. These choices were often determined by surgeon's personal preference according to their experiences. Shuang Ho hospital has top three quantity of hemorrhoidectomy in Taiwan. So, a randomized controlled trial is conducted to evaluate the difference between hemostatic agents use after anal surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients who undergo conventional hemorrhoidectomy or stapled hemorrhonidpexy are include.
* Patients who undergo fistulectomy or fistulotomy are include.

Exclusion Criteria:

* Emergency operation
* Patients with colorectal cancer
* Liver cirrhosis
* Patients with coagulopathy
* Patients with HIV infection
Dexmedetomidine and Propofol As Sole Sedative Agent for Patients Undergoing Arteriovenous Fistula Surgery

The investigators designed a prospective randomized study to compare the conventionally used sedative drug propofol with a latest alternative dexmedetomidine (DEX), in patients with end-stage renal disease undergoing arteriovenous fistula (AVF) surgery.


Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria were patients undergoing arteriovenous fistula (AVF) surgery aged between 20-70 with end stage renal failure on dialysis treatment.

Exclusion Criteria:

* Exclusion criteria were decompensated respiratory or heart failure, liver failure, obesity (body mass index\>30), severe obstructive sleep apnea, need for additional different drugs for sedation, chronic use of alcohol, opioids or other sedative drugs,mental disorders, cognitive disorders, language problems and history of allergy to any medications used in this study.
The Bronchiolitis Follow-up Intervention Trial

This study evaluates the value of routine follow-up with a child's pediatrician after hospitalization for bronchiolitis. Parents of half of participants will be instructed to follow-up with the child's pediatrician regardless of symptom resolution, while the other half will be instructed to follow-up on an as-needed basis (only if the child worsens, doesn't improve, or other concerns develop).

Bronchiolitis is highly prevalent and burdensome among children less than 2 years of age. For this reason, many therapies have been tried by providers and studied by researchers. Unfortunately, interventions have largely been shown to be ineffective, prompting campaigns to reduce use of ineffective therapies. One commonly prescribed but thus far unstudied intervention often provided to children discharged after hospitalization for bronchiolitis is routine follow up with their pediatrician. Whether the costs and time spent for these visits are worthwhile depends on the extent to which the child and the child's parents benefit.

Eligibility Criteria:
Inclusion Criteria:

* Children less than two years of age who are hospitalized with an attending physician diagnosis of bronchiolitis.

Exclusion Criteria:

* Chronic lung disease
* Complex or hemodynamically significant heart disease
* Immunodeficiency
* Neuromuscular disease
* Discharged home with medication for withdrawal
* Inpatient team believes the child should follow up with their PCP