cyrilzakka/clinical-trials huggingface dataset:
A Study to Identify and Characterize LAL-D Patients in High-risk Populations

The objective of this study is to determine the frequency of Lysosomal Acid Lipase Deficiency (LAL D) by lysosomal acid lipase (LAL) enzyme activity assay in patients who are considered to be at risk.


Eligibility Criteria:
Inclusion Criteria:

1. Non-obese\*\* patients with elevated low-density lipoprotein (LDL)
2. Non-obese\*\* patients with low high-density lipoprotein (HDL)
3. Non-obese\*\* patients with unexplained and persistently elevated liver transaminases,
4. Non-obese\*\* patients with hepatomegaly
5. Patients with cryptogenic cirrhosis
6. Patients with biopsy-proven microvesicular or mixed micro/macrovesicular steatosis without a known etiology
7. Patients with presumed Familial Hypercholesterolemia (FH) in which genetic analysis was performed for the genes encoding the low-density lipoprotein receptor (LDLR), Apo-B and PCSK9 genes and no disease-causing mutations were identified
8. Patients with presumed FH with unclear family history
9. Patients with autosomal recessive hypercholesterolemia (other than homozygous FH)
10. Patients with autosomal recessive low HDL of unknown etiology

Also, patient must meet the following:

* Patient or patient's parent or legal guardian (if applicable) consents to participate in the study and provides informed consent prior to any study procedures being performed. If the patient is of minor age; he/she is willing to provide assent where required per local regulations, and if deemed able to do so.
* Patient is willing and able to comply with protocol requirements.
* Patients who do not fall into one of the aforementioned categories (cohorts) but are considered highly suspicious for LAL D should be tested to rule out the disorder outside of the study at the discretion of the Investigator.

Exclusion Criteria:

* Active viral hepatitis;
* Other confirmed genetic liver diseases (e.g., Wilson's disease, hemochromatosis, alpha 1-antitrypsin).
Effectiveness of a 6-week Hippotherapy Program in Children With Autism Spectrum Disorder

The prevalence of autism spectrum disorders (ASD) has increased dramatically in the last decade. The increasing occurrence of ASD creates an imperative need to test the effectiveness and efficacy mechanisms of appropriate interventions. Hippotherapy (HPOT) is a treatment option that has been show beneficial for children with ASD as well as other children with developmental disorders. The current projects focuses on understanding the mechanisms of HPOT efficacy and evaluating a short-term HPOT program for children with ASD.

The incidence of autism spectrum disorders (ASD) has increased dramatically in the last decade. The latest report from the Centers for Disease Control and Prevention state that 1 in 59 children are being diagnosed with ASD and it is four times more prevalent in boys than girls. Common treatments for children with ASD are applied behavioral therapy, occupational and speech therapy, which are used solely or in combination. Hippotherapy (HPOT) is another treatment option that has been shown to positively impact various aspects of behavior. This pilot project aims to determine the effects of a 6-week HPOT program on movement and social behavior of children with ASD and to investigate the underlying mechanisms of why HPOT is successful for ASD through the coupling of physiological and temperamental responses between horse and rider. The approach involves examining these skills pre, during, and post HPOT intervention in children diagnosed with ASD. A group of aged matched children with typical development will serve as the control group. Innovative measures of physiological coupling and temperament between horse and rider as well as objective and quantitative measures of movement and social behavior and caregiver perception will be collected. The investigators anticipate that following completion of the proposed study, they will provide the necessary foundation to understand the mechanisms of HPOT, and thus provide a new framework to test clinical trials of HPOT and human-animal interaction, and ultimately improve the lives of those diagnosed with ASD and their families.

Eligibility Criteria:
For the children with Autism Spectrum Disorders:

Inclusion Criteria:

1. diagnosis of ASD based upon the Autism Diagnostic Observation Schedule and parent interview,
2. medical approval for participation in the HPOT activity,
3. no other medical or psychiatric diagnoses besides ASD
4. tolerate helmet on head and attachments of the movement and heart rate sensors.

The inclusion criteria for the TD children will be:

1. no diagnosis or family history of ASD
2. no other neurodevelopmental or musculoskeletal disorder
3. tolerate helmet on head and attachments of the movement and heart rate sensors.
4. medical approval for participation in the HPOT activity,

Exclusion Criteria:

1. under 5 years of age or over 10 years of age
2. has a serious comorbid medical diagnosis
3. major vision or hearing impairments
4. severe behavioral problems
5. an orthopedic or genetic diagnosis
Rate of Gastric Emptying in Term Parturients Undergoing Elective Cesarean Section

The aim of the study is to use sequential ultrasound evaluation of the gastric volume to determine how long it takes for the stomach of a fasting pregnant woman at term, admitted for elective cesarean section, to empty after ingesting a 400ml carbohydrate drink (Nutricia preOp).

Recent research suggests that attention to nutrition before operation leads to a speedier recovery through moderating the metabolic responses to surgery, improving well-being, decreasing post-operative insulin resistance and attenuation loss of lean body mass. On other hand there are fasting guidelines in place to prevent from pulmonary aspiration. The current fasting guidelines of 2hrs for clear fluids come from some small studies performed in healthy non-pregnant adults and consensus agreement.

The aim of the study is to use sequential ultrasound evaluation of the gastric volume to determine how long it takes for the stomach of a fasting pregnant woman at term, admitted for elective cesarean section, to empty after ingesting a 400ml carbohydrate drink (Nutricia preOp - a clear, non-carbonated, lemon flavoured, carbohydrate drink that provides 0.5kcal/ml).

Patients who are fasting according to the current guidelines and agree to partake in the study will, on the day of their elective LSCS, be given a 400ml carbohydrate drink at least 2hours before their scheduled theatre time. Patients will then have their gastric volume assessed at 15minutes intervals for 2 hours to determine how long it takes for the ingested fluid to leave the stomach. The results of the study will give us more information regarding gastric emptying in the investigator's patient population and may lead to reduced fasting times, increasing patient comfort and improving the patient experience.

Eligibility Criteria:
Inclusion Criteria:

* Elective LSCS
* 18yrs
* gestation \>38 gestation weeks

Exclusion Criteria:

* Multiple pregnancy
* Previous upper GI surgery
* Known disorder of gastric emptying
* Hiatus Hernia
* BMI \>40
* Diabetes Mellitus, Gestational Diabetes
Phase I Study of OPC-61815

To investigate the effects of intravenous administration of OPC-61815 at 16 and 32 mg on QT/QTc interval in healthy male subjects


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) \[body weight in kg / (height in m)2\] of at least 18.5 kg/m2 and less than 25.0 kg/m2 as a result of at the screening examination
* Judged by the investigator or subinvestigator to be capable of providing written informed consent prior to start of any trial-related procedures and capable of complying with the procedures for this trial

Exclusion Criteria:

* Subjects with a medical history of convulsive disorder, long QT syndrome (including family history), syncope during swimming, or any other type of syncope or cryptogenic loss of consciousness
* Subjects with a serum electrolyte abnormality (hypokalemia, hypomagnesemia, hypocalcemia, etc)
* Subjects with a family history of sudden death
Precision-MRD: Prospective Observational Study of Biomarker-directed Systemic Therapy for Colorectal Cancer Patients With Minimal Residual Disease

The goal of this clinical research study is to learn about the effects of biomarkertargeted therapy on ctDNA in patrticipants with CRC and MRD.

This is an observational study. Participants will be monitored while receiving biomarker-directed therapy that is determined by your treating oncologist (cancer doctor) per standard of care, independent of this study.

Primary Objective

• To estimate the rate of ctDNA clearance at 6 months following initiation of biomarker-directed targeted therapy in colorectal cancer (CRC) participants with minimal residual disease (MRD).

Secondary Objectives

* To evaluate dynamics of ctDNA mutant allele fractions following initiation of biomarker-directed targeted therapy in MRD-positive CRC participants.
* To estimate the rate of disease recurrence at 1 year following initiation of biomarker-directed targeted therapy in MRD-positive CRC participants.

Eligibility Criteria:
Inclusion Criteria

1. Male or female subjects aged \> 18 years.
2. Histologically or cytologically confirmed diagnosis of colorectal adenocarcinoma.
3. Stage II-IV disease per current AJCC staging criteria with no definitive radiographic evidence of disease following locoregional treatment. Small indeterminate lesions measuring \< 10 mm may be permitted at the discretion of the principal investigator.
4. Presence of one of the following targetable biomarkers on tumor or blood molecular testing: BRAF V600E mutation (Cohort A), KRAS G12C mutation (Cohort B), MSI-H status (Cohort C), and HER2 amplification (Cohort D).
5. Positive ctDNA blood test obtained \> 21 days after surgery or last administration of adjuvant therapy.
6. Prescribed one of the following standard-of-care targeted therapy regimens: BRAF V600E Inhibitor + anti-EGFR antibody for BRAF V600E-mutated tumors, KRAS G12C Inhibitor + anti-EGFR antibody for KRAS G12C-mutated tumors, anti-PD-1 antibody +/- anti-CTLA-4 antibody for MMRd/MSI-H tumors, or anti-HER2 therapies for HER2 amplified tumors.

Exclusion Criteria

1. Prior exposure to the following classes of biomarker-directed therapies: BRAF V600E inhibitors, anti-EGFR antibodies, KRAS G12C inhibitors, anti-PD-1/PD-L1 antibodies, anti-CTLA-4 antibodies, or anti-HER2 therapies
2. Presence of a concurrent malignancy requiring active treatment
3. Inability to provide informed consent
4. Children will not be enrolled in this study
5. Pregnant women will not be enrolled in this study
6. Cognitively Impaired subjects will not be enrolled in this study
Enhancing Function Using the RF Microstimulator Gait System Following Stroke 2008

The purpose of the study is to investigate new Technology for recovery of ankle walking function after stroke.

Background and Purpose: Conventional rehabilitation does not restore normal, upper limb function or normal gait to many stroke survivors. Functional neuromuscular stimulation (FNS) has shown promise for functional enhancement of both upper and lower limb motor control following stroke. Gains included muscle activation latencies, strength, coordination, upper limb functional tasks, gait kinematics, walking endurance, and quality of life. The purpose of the proposed work is to test the radio frequency-controlled (RF) Microstimulator (RFM) Gait System regarding system performance and subject response to treatment.

Methods: This is a feasibility study in which up to four subjects will receive the (RFM) Gait System. Up to ten RFMs will be placed for a given subject. An RFM ankle muscle system will be used to train ankle gait components. A separate RFM system will be used to train knee gait components. Subjects will be treated for 6 months, four sessions/wk. Primary outcome measures for the RFM Gait System will be: kinematic swing phase gait components and walking endurance. Secondary outcome measures will include: strength, coordination, spasticity, function, and quality of life. Data collections will occur at months 1, 3 and 6, and for follow-up times up to a year after the end of treatment. The results of the RFM ankle system have the potential to provide a new technology for ankle muscle gait components.

Eligibility Criteria:
Inclusion Criteria:

* Sufficient endurance to participate in rehabilitation sessions.
* Medically Stable
* Age \>21 years.
* Inability to perform normal ankle coordinated gait components.
* Participants should be able to walk and keep balance without physical assistance from another person

Exclusion Criteria:

* Acute or progressive cardiac, renal, respiratory, neurological disorders or malignancy.
* Lower motor neuron damage or radiculopathy
* Allergy or contraindication to anesthesia, Versed, (or comparable substitute.
* Active implantable device (e.g. pacemaker, implantable cardiac defibrillator, neurostimulator, or drug infusion device.
* Pregnancy
Effects of Greenselect Phytosome® on Weight Maintenance After Weight Loss in Obese Women

This study evaluates whether supplementations with a highly bioavailable green tea extract may help obese women to counteract weight regain after a 3-month weight loss intervention.

Most obese subjects regain weight after weight loss due to compensatory adaptations finalized to maintain stable body energy stores. In lean or obese individuals, maintenance of a 10% or greater reduction in body weight is associated with a decline in 24-hour energy expenditure of approximately 20%-25%. The restraint of the energy expenditure decline during dieting by green tea (GT) preparations should be a useful strategy to facilitate weight maintenance. To increase absorption of GT, the investigators used a formulation with phospholipids (Greenselect Phytosome® ) added with piperine, a thermogenic agent and a booster of absorption for various phenolics.

At the end of a 3-month lifestyle intervention, all patients giving written informed consent were randomly assigned to two groups for the weight-maintenance phase: 20 of them were supplemented twice a day for 3 months with a dietary supplement (Globes®, Pharmextracta, Pontenure, Piacenza, Italy) and 20 with placebo.Women were blind to the supplementation throughout the whole trial. All women attended a monthly clinical visit during the supplementation period and 3 months after the end of supplementation.

Eligibility Criteria:
Inclusion Criteria:

* outpatient
* ≥18 years of age
* body mass index (BMI) ≥ 30 kg/m2
* a sufficient level of education to understand study procedures and be able to communicate with site personnel

Exclusion Criteria:

* breast feeding or pregnancy
* history of cardiovascular or cerebrovascular events
* uncontrolled hypertension
The Difference in Presentation Level of Variant Receptors in Female Breast Tissue in Macromastia and Micromastia

There are more and more macromastic women in Taiwan, which may due to the high cholesterol foods. Patients with macromastia not only suffered from physical problems but also psychological discomforts.

Large breasts cause neck and back pain, irritating grooves, cut in the skin of the shoulders by the pressure of brassiere straps, breast pain, and maceration and dermatoses in the inframammary region. From a psychological point of view, excessively large breasts can be troublesome focus of embarrassment for the teenager as well as the woman in her senior years. Unilateral hypertrophy with asymmetry heightens embarrassment. Thus, patients seek to reduce the size of their breasts.

In the human female, variant receptors were detected in epithelial cells in normal breast tissue, benign breast lesions, breast carcinoma tissue, and breast cancer cell lines2-11. The cause of the difference in breast development status is still unclear. Abnormalities at the tissue receptor level may be important in the pathophysiology of macromastia. This study aimed to make clear the difference in variant receptor levels between breast hypertrophy patients and macromastia ones by examining the receptor levels in breast tissue. Then, we could explore the possible etiology of mammary hypertrophy and macromastia.

Eligibility Criteria:
Inclusion Criteria:

* patients receiving reduction mammoplasty

Exclusion Criteria:

-
The Effect of Sumatriptan and Placebo on Cilostazol Induced Headache

To develop a pragmatic migraine model the investigators will induce headache in healthy volunteers and in patients with migraine without aura with a phosphodiesterase inhibitor (cilostazol). If the headache responds to sumatriptan, the model can be used to test new drug candidates.

There remains a great need for more effective anti-migraine drugs with fewer side effects. Human experimental models are valuable in early phase development of new anti-migraine drugs but useful models have not yet been developed. The investigators' group has shown that Cilostazol, a phosphodiesterase inhibitor induce headache/migraine in both healthy volunteers and in patients with migraine without aura (MO). To validate this model, the headache must respond to specific migraine treatment with sumatriptan.

Hypothesis: Cilostazol induces a migraine-like headache in both healthy subjects and in MO-patients and induced headache responds to a specific anti migraine drug; sumatriptan.

Aim: Developing a pragmatic and valid model for the testing of new anti-migraine drugs.

Eligibility Criteria:
Inclusion criteria:

Healthy:

* Healthy subjects of both sexes
* Age 18-70 years
* Weight 50-90 kg.
* Females were requested to use effective contraception.

Migraine patients:

* Migraine patients who meet IHS criteria for migraine with or without aura of both sexes
* 18-70 years
* 45-95 kg.

Exclusion Criteria:

Healthy:

* Any type of headache (except episodic tension-type headache \< 1 day per week)
* Serious somatic or psychiatric disease
* Pregnancy
* Intake of daily medication (except oral contraceptives).

Migraine patients:

* Any other type of headache then migraine without aura (except episodic tension-type headache \< 1 day per week)
* Serious somatic or psychiatric disease
* Pregnancy
* Intake of daily medication (except oral contraceptives)
TRIP-patch vs Duplex

To measure saturation and desaturation of the cavernosal tissue with a cutaneous placed penile sensor, before and during full rigidity. To validate discriminating sensor-readings between flaccid state and full rigidity of the penis

To measure saturation and desaturation of the cavernosal tissue with a cutaneous placed penile sensor, before and during full rigidity. To validate discriminating sensor-readings between flaccid state and full rigidity of the penis

Eligibility Criteria:
Inclusion Criteria:

* Indication for a penile duplex in our andrology clinic Signed informed consent Male Between 18-60 year

Exclusion Criteria:

* Patients who are unwilling to sign written informed consent
* Patients unable to undergo a duplex of the penis
* Patients with sickle cell anemia because this could affect the accuracy of the measurements
Effectivenes of Erector Spinae Plane Block in Percutaneous Nephrolithotomy?

This study investigates the effectiveness of the erector spinae plane block (ESPB) in pain management of patients undergoing PNL.

Although percutaneous nephrolithotomy(PNL) is a minimally invasive procedure, it causes severe postoperative pain due to dilatation of the renal capsule and parenchymal duct and peritubal distension of the nephrostomy tube. PNL-related pain has a limited response to oral and intravenous treatments. The primary aim of our study is to investigate the effectiveness of the erector spinae plane block (ESPB) in pain management of patients undergoing PNL.

Our secondary aim is determining if any possible clinical effect of ESPB in terms of serial peak expiratory flow measurements, postoperative agitation score of the patient (Riker Score), ambulation time, length of hospital stay.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing PNL between 18-65 years old

Exclusion Criteria:

* serious cardiac, respiratory, hepatic, renal or haemotologic disease
* mental disorder and hearing problem
* anxiety, depression and / or other psychiatric disorders
* pregnancy
* refusal of patient
* Allergy or contraindications to drugs used in the study
* ASA \> 2 Inflammation or infection over injection site Obese patients BMI ≥35/
Efficacy and Safety of Donafenib in Patients With Advanced Hepatocellular Carcinoma

Donafenib versus sorafenib for advanced hepatocellular cancer.

This phase 3 study of donafenib, an oral multikinase inhibitor that targets Raf kinase and receptor tyrosine kinases, is to assess efficacy and safety in patients wiht advanced hepatocellular carcinoma (HCC).The study is a randomised,controlled,multicentre study.The controlled drug is sorafenib(Nexavar).The primary endpoint is overall survival.

Eligibility Criteria:
Inclusion Criteria:

* Above 18 years old;
* Patients with measurable, histologically or clinical proven, inoperable HCC;
* Patients wtih measurable lesion and proved by independent radiology committee(IRC);
* Child-Pugh (CP) score of 7 or less；
* Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less;
* Patients had not received prior systemic treatments for HCC;
* Life expectancy at least 3 months;
* Adequate hepatic and renal function;
* Adequate hematologic function (platelet count,≥75×109per liter;hemoglobin ≥9.0g per deciliter;neutrophil≥1.5×109per liter,);
* Prothrombin time international normal.

Exclusion Criteria:

* Patients received operate in 3 months;
* Patients received transcatheter arterial chemoembolization（TACE） in 4 weeks;
* Patients had received systemic therapy;
* Patients had prior treatment with sorafenib;
* Central nervous system(CNS) involvement;
* Severe or mild-degree ascitic fluid;
* Main portal vein tumor thrombus;
* Inferior venae cava tumor thrombus.
Comparison of Different Anterior Cruciate Ligament Surgery Techniques in Skeletally Immature Patients.

This cohort study compares to groups of patients with reconstruction of anterior cruciate ligament (ACL). Patients in group 1 had ACL-reconstruction in the years 2001-2010 with a transphyseal drilling technique. Patient in group 2 had ACL-reconstruction in the years 2013-2018 with a physeal sparing technique.

Data including: x-ray exam, patient reported questionnaires and clinical evaluation will be compared between the 2 groups.


Eligibility Criteria:
Inclusion Criteria:

* ACL reconstruction as skeletally immature

Exclusion Criteria:

* Other ligament injuries in index knee
* Other ligament injuries in opposite knee
* Revision ACL reconstruction
* Pregnant
* Not able to read or understand the danish languages
Popliteal Nerve Block for Postoperative Pain Control in Ankle and Hindfoot Reconstruction

The purpose of this study is to evaluate outcomes of popliteal nerve blocks for postoperative pain control in patients undergoing ankle and hindfoot reconstruction surgeries. The following outcomes will be analyzed: length of hospital stay, level of pain control, pain medication use, complications, and patient satisfaction.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients ≥ 18 years old
* Patients undergoing ankle, subtalar, pantalar, triple, or tibiotalocalcaneal arthrodesis (CPT codes 27870, 28715, 28725, or 28740)
* Patients undergoing total ankle arthroplasty (CPT code 27702)
* Patients with a preoperative surgical plan to receive a popliteal nerve block during the postoperative period
* Patients whom can be reasonably expected to understand and comply with patient-reported postoperative data collection and surveys

Exclusion Criteria:

* Patients undergoing an ankle or hindfoot reconstruction procedure whom are medically ineligible to receive a safe popliteal nerve block (i.e. patients with neuropathy)
* Patients with documented substance abuse (i.e. history of narcotic abuse could confound pain outcomes)