cyrilzakka/clinical-trials huggingface dataset:
ST Segment Detection Study

The purpose of ST Detect study is to evaluate whether naturally occurring spontaneous coronary events and exercise induced cardiac ischemia, give rise to detectable changes on intracardiac electrogram (EGM) signals in patients that are indicated for an Implantable Cardioverter Defibrillator (ICD) who have coronary artery disease.


Eligibility Criteria:
Inclusion Criteria:

* Subject is indicated for an ICD implantation
* AND subject must meet ONE of the following:

  * Prior acute coronary event
  * Previously underwent Percutaneous Coronary Intervention (PCI) or stent procedure
  * Multivessel disease
  * Positive stress test completed with evidence of ischemic heart disease, as determined by physician, and no subsequent successful revascularization

Exclusion Criteria:

* Subject is currently dependent on ventricular pacing
* Subject has Left Bundle Brunch Block (LBBB) and/or wide QRS
* Subject has chronic Atrial Fibrillation (AF)
* Subject has dementia
* Subject is indicated for a single chamber device
* Subject requires a right sided or abdominal ICD implant
* Subject is pregnant or in fertile age without secure birth control
* Subject has New York Heart Association (NYHA) class IV or refractory heart failure
* Subject is not expected to survive greater than 12 months
* Subject is participating in other confounding research studies
Transcutaneous Electrical Acupoint Stimulation on Gastrointestinal Function After Cesarean Section

To determine whether treating by transcutaneous electrical acupoint stimulation (TEAS) during perioperative could alleviate the postoperative gastrointestinal complications after cesarean section under combined spinal epidural anesthesia compared with control and non-acupoint group.

Acupuncture is a traditional Chinese medical technique that involves the insertion of needles at acupoints to treat diseases.Clinical evidence supports the efficacy of acupuncture treatment in many applications. Some previous studies reported that stimulation at some acupoint exerted good effects on the digestive system.Compared with acupuncture, transcutaneous electric acupoint stimulation(TEAS) is a non-invasive technique that has similar effects to acupuncture.We hypothesize that TEAS before anesthesia and during surgery would decrease the morbidity and mortality of postoperative complications in 30 days after Cesarean section.

Eligibility Criteria:
Inclusion Criteria:

1. ASA physical status 1or2, scheduled for elective cesarean section under combined spinal epidural anesthesia
2. Gestational age ≥38 weeks
3. Provide written informed consent

Exclusion Criteria:

1. ASA status≥Ⅲ
2. Patients undergoing surgery within 12 h of admission to hospital
3. Patients with fetal anomaly，medical or obstetric complications such as Diabetes mellitus、Hypertension、Obesity(BMW≥35)
4. Patients suffered from drug addiction or impaired mental state
5. Patients who have a history of gastrointestinal surgery or chronic gastrointestinal disease.
6. Patients with contraindications to the use of electro-acupuncture, such as skin damage or infection at the acupoints
7. Patients with experience of transcutaneous electrical stimulation treatment
8. Participate in the other clinical trial 3 months before the enrollment
9. Not suitable to participate in this experiment
Light Therapy Intervention in Individuals With Parkinson's Disease

The study looks to investigate the effects that light therapy delivered to the frontal cortex could have on Parkinson's disease related symptoms ( both cognitive and motor). The therapy is a non invasive technique that deliverers low level wavelength light to the front part of the head for 12 minutes. for this study the therapy will be done 3 times a week for 6 weeks. To measure the potential effects on the therapy in Parkinson symptoms, we will do a set of cognitive and motor test before and after the intervention to measure any changes as well as control for any potential markers such as age, sex, disease level, medication and exercise.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Parkinson disease

Exclusion Criteria:

1. Participants who are unable to comply with study visit/testing requirements (e.g.

   participants who cannot go off PD medication for the pre-, post-, and 3-month assessments).
2. Participants who are unable to provide consent.
3. Participants with a Deep Brain Stimulation (DBS) device.
4. Participants who have a history of a psychiatric disorder
5. Participants with PD who have other concurrent movement/neurological conditions, including dystonia, dementia, epilepsy etc.
6. Participants with a clinical diagnosis of PD that is not considered primary (e.g.

   vascular parkinsonism) or participants where an atypical form of parkinsonism is suspected (e.g., progressive supranuclear palsy, multiple system atrophy).
7. Participants with a history of cancer (whether treated with chemotherapy and/or radiotherapy or not).
8. Participants with a history of a recent concussion or any facial, neck, or head injury within the last 6 months. UD IRB Approved: 03/12/2025 IRBNet ID#: 2277769-2 I/C from Rev. 01/2024 Page 3 of 10 Participant's Initial's ________
9. Known injury or disease that might interfere with motor function in the proposed experiments (e.g., stroke, traumatic brain injury, extrapyramidal dysfunction, neuromuscular disease, orthopedic problems that impair movement).
10. Participants with a history of photosensitivity.
11. Participants who are not able to walk unassisted for 2 minutes
The Effect of Beta-blocker on Chronotropic Response and Cardiorespiratory Fitness in Patients With Atrial Fibrillation

This is a prospective study to evaluate changes in exercise capacity and chronotropic response to exercise before and after beta-blocker dosage reduction in patients with atrial fibrillation (AF).

Rate control therapy is the first-line treatment for atrial fibrillation (AF). Resting heart rate(HR) is the treatment target of rate control therapy in current clinical practice; However, the optimal value for resting heart rate in AF remained unclear. Beta-blocker(BB) is widely used as rate-control agent. It is concerned that excessive use of BB might lead to a negative effect on exercise capacity in patients with AF. The aim of this study is to explore the effect of Beta-blocker on hemodynamic parameters and peak oxygen uptake during cardiopulmonary exercise test (CPET).

Eligibility Criteria:
Inclusion Criteria:

1. \> 20 years of age.
2. Clinically stable patients with persistent atrial fibrillation using beta-blocker as rate-control agent without dosage adjustment for at least 3 months.
3. Resting heart rate \< 80 bpm.
4. Left ventricular ejection fraction \> 50%.

Exclusion Criteria:

1. Beta-blocker usage due to indications other than rate control for atrial fibrillation.
2. Inability to perform a cardiopulmonary exercise testing.
3. Presence of contraindications for cardiopulmonary exercise testing according to the American College of Sports Medicine's Guidelines for Exercise Testing and Prescription.
4. Patients with implantable cardioverter defibrillator or pacemaker.
5. Pregnancy.
6. Inability to provide informed consent.
A Study of MK0663 and an Approved Drug in the Treatment of Osteoarthritis (0663-077)(COMPLETED)

The purpose of this study is to compare the safety and effectiveness of an investigational drug and an approved drug in the treatment of osteoarthritis of the knee and hip.

The duration of treatment is 26 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Osteoarthritis of the knee or hip which requires treatment with medication for pain relief

Exclusion Criteria:

* Any known allergies to the study drugs
Adjuvant Entecavir or Tenofovir for Postoperative HBV-HCC

This study aims to compare the effect of antiviral therapy with entecavir or tenofovir for hepatitis B virus-related hepatocellular carcinoma after radical hepatectomy. Included patients will randomly divide into two groups.

Hepatocellular carcinoma (HCC) is associated with a poor prognosis, and its incidence has increased dramatically in many countries. Hepatectomy is a radical therapy for early-stage HCC. However, even after radical resection, the prognosis for HCC patients remains discouraging because of the high recurrence rate and frequent incidence of intrahepatic metastasis. Therefore, preventing HCC recurrence is very important.

Hepatitis B virus (HBV) infection is the major risk factor for HCC development in China. Some retrospective studies have shown that tenofovir or entecavir treatment for HBV-related HCC patients can effectively reduce the HCC recurrence rate and increase the survival rate after hepatectomy. However, which drug has more efficacy has not been addressed.

Eligibility Criteria:
Inclusion Criteria:

* Underwent hepatic resection.
* Diagnosis of HCC was confirmed by postoperative histopathology.
* Positive of HBsAg, HBeAg, or HBV DNA.
* Child-Pugh A or B liver function.

Exclusion Criteria:

* Anti-HCV(+)
* Diagnosis of HCC was not confirmed by postoperative histopathology of surgical samples after surgery.
Anxiety Intervention for Preschool Children With ASD

This study evaluates the feasibility, acceptability, and preliminary efficacy of a treatment program for anxiety in preschool children with autism spectrum disorder.

Anxiety is highly prevalent in individuals with ASD with lifelong impact. In this population, anxiety often emerges when children are very young, yet there are no evidence-based treatments for this age group. Cognitive-behavioral treatment (CBT) successfully reduces anxiety levels in young, typically developing children and older children with ASD. This study pilots the DINO Strategies for Anxiety and fear of Uncertainty Reduction (DINOSAUR) program, which is an integrated treatment program that utilizes CBT modified for young children with ASD. The treatment includes heavy doses of parent training to reduce accommodation of the child's anxiety symptoms and interventions targeting fear of uncertainty, a common fear in children with ASD. The feasibility, acceptability, and preliminary efficacy of this treatment program will be studied.

Eligibility Criteria:
Inclusion Criteria:

* Age 4 years 0 months to 6 years 11 months
* NVIQ ≥ 85 based on Mullen Scales of Early Learning or Stanford Binet 5
* Expressive and Receptive Language scores ≥ 85 based on Preschool Language Scale - Fifth Edition or Orals or Written Language Scales, Second Edition
* DSM-5 diagnoses of Separation Anxiety, Social Anxiety, and/or Generalized Anxiety Disorder and/or the distinct diagnosis of Other Social Fear based on the results of the Anxiety Disorders Interview Schedule/ASA

Exclusion Criteria:

* History of psychological trauma
* History of neurologic illness
* Parent substance abuse, bipolar disorder, psychosis
* Parents require support from a medical interpreter
* Child displays severe behavior challenges
* Severe eyesight or hearing impairments that may interfere with the protocols
* Child's behavior prevents their ability to participate in a 1 hour group consisting of various activities (e.g., listening to a story, snacks, playing movement games, completing a craft)
The Effect of Contralateral Limb Training on Functional Outcomes in Patients With ACL Reconstruction

Quadriceps and hamstring muscle strenghts have important role in returning to sport after ACL reconstruction and one of the main focus of rehabilitation is to improve strenght of these muscles. With the strenghtening of the contralateral limb (cross-over training) we aimed to improve the strenght of the quadriceps

Returning to sport after ACL reconstruction is not at desired level among athletes. Quadriceps and hamstring muscle strenghts have important role in returning to sport after ACL reconstruction. Cross-over training is recomended during rehabilitation after ACL reconstrucion. Yet duration of the training, frequancy and type of exercise interention are not clear for the cross-over training. Ain of the study is to investigate the effects of cross-over training on muscle strenght

Eligibility Criteria:
Inclusion Criteria:

* having surgery of ACL reconstruction on one side
* having no problem at least six month on the nonsrgical side
* recieving the rehabilitation programme at hacettepe university, physiotherapy department

Exclusion Criteria:

* refusing to include to the study
* having revision ACL surgery
* addition of PCL or cartilage surgery addition to the ACL surgery
* not participating to the rehabilidation program regularly over 3 month after sugery
Medical and Psychiatric Co-Morbidity Among Treatment Resistant Patients With Major Depression Disorder

Assessing psychiatric and physiological co-morbidity in TRD and non-TRD patients


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of MDD
* Received at least one adequate treatment

Exclusion Criteria:

-
Safety Study of Peptide Cancer Vaccine To Treat HLA-A*24-positive Advanced Non-small Cell Lung Cancer

The purpose of this study is to evaluate the safety, tolerability, immune response and clinical efficacies of HLA-A\*2402 restricted epitope peptides URLC10, CDCA1, and KIF20A emulsified with Montanide ISA 51 for advanced non-small cell lung cancers.

The investigators previously identified three novel HLA-A\*2402-restricted epitope peptides, which were derived from three cancer-testis antigens, URLC10, CDCA1, and KIF20A, as targets for cancer vaccination against lung cancer. In this phase I trial, the investigators examine using a combination of these three peptides the safety, immunogenicity, and antitumor effect of vaccine treatment for HLA-A\*2402-positive advanced non-small cell lung cancer patients who failed to standard therapy.

Eligibility Criteria:
Inclusion Criteria:

1. NSCLC that can not undergo curative surgery and treatment, and is refractory to standard chemotherapy and radiotherapy
2. ECOG performance status 0-2
3. Age between 20 to 85
4. Clinical efficacy can be evaluated by some methods
5. No prior chemotherapy, radiation therapy, hyperthermia or immunotherapy within 4 weeks
6. Life expectancy \> 3 months
7. Laboratory values as follows 1500/mm3 \< WBC \< 15000/mm3 Platelet count \> 75000/mm3 Asparate transaminase \< 3 X cutoff value Alanine transaminase \< 3 X cutoff value Total bilirubin \< 3 X cutoff value Serum creatinine \< 2X cutoff value
8. HLA-A\*2402
9. Able and willing to give valid written informed consent

Exclusion Criteria:

1. Active and uncontrolled cardiac disease (i.e. coronary syndromes, arrhythmia)
2. Myocardial infarction within six months before entry
3. Breastfeeding and Pregnancy (woman of child bearing potential)
4. Active and uncontrolled infectious disease
5. Concurrent treatment with steroids or immunosuppressing agent
6. Other malignancy requiring treatment
7. Non-cured traumatic wound
8. Decision of unsuitableness by principal investigator or physician-in-charge
Compare Efficacy/Safety of Repeat Doses of Ferumoxytol With Iron Sucrose in CKD Subjects With IDA and on Hemodialysis

The objectives of this study are to compare the efficacy and safety of repeat doses of intravenous (IV) ferumoxytol with IV iron sucrose for the treatment of IDA in subjects with hemodialysis-dependent CKD.

This was a Phase IV, randomized, open-label, active-controlled, multicenter clinical trial designed to evaluate the safety, efficacy, and frequency of use of ferumoxytol compared to iron sucrose for the episodic treatment of IDA in hemodialysis subjects with CKD over a 1-year period. As part of this Main Study, an Oxidative Stress Substudy and an MRI Substudy were conducted. The Oxidative Stress Substudy, to be run concurrently with the initial TP of the Main Study, was to examine the varying degrees to which iron sucrose and ferumoxytol may or may not induce oxidative stress in vitro in subjects undergoing hemodialysis. The MRI Substudy, to be run concurrently with the Main Study and continue for an additional 11 months, was to assess the potential for deposition of iron in cardiac, hepatic, and pancreatic tissues and changes in laboratory parameters over a 2-year period.

Eligibility Criteria:
Key Inclusion Criteria include:

1. Males and females ≥18 years of age
2. Diagnosis of CKD
3. Subjects on dialysis must have been on dialysis for at least 3 months prior to screening
4. Female subjects of childbearing potential who are sexually active must be on an effective method of birth control for at least 1 month prior to screening and agree to remain on birth control until completion of participation in the study

Key Exclusion Criteria include:

1. History of allergy to either oral or IV iron
2. Female subjects who are pregnant or intend to become pregnant, breastfeeding, within 3 months postpartum, or have a positive serum or urine pregnancy test
3. Parenteral iron therapy within 30 days prior to screening or red blood cell (RBC)/whole blood transfusion within 14 days prior to screening or planned during the study
Safety and Efficacy of Rotational Atherectomy (RA) in Coronary Dissection

This study is aimed at examining the safety and efficacy of rotational atherectomy (RA) in nondilatable calcified lesion complicated by coronary dissection during percutaneous coronary intervention (PCI) procedure.

Coronary artery dissection is a contraindication for the use of rotational atherectomy, since rotational atherectomy may propagate coronary dissection. In the presence of coronary dissection, conservative management is suggested for approximately 4 weeks to permit the dissection to heal prior to treatment with rotational atherectomy. However, a lot of patients have frequent angina attacks and some patients develop serious complications including abrupt vessel closure during this period. Thus, immediate strategies cope with coronary dissection induced by balloon dilation is needed for the early recovery of those patients. The present study was performed to compare the safety and efficacy of immediate RA and delayed RA in the treatment with nondilatable calcified lesion complicated by coronary dissection.

Eligibility Criteria:
Inclusion Criteria:

* age between 30 and 85 years old
* nondilatable calcified lesion complicated by coronary dissection during percutaneous coronary intervention (PCI) procedure
* Coronary artery dissection type A, B and type C according to the National Heart, Lung and Blood Institute (NHLBI) coronary dissection criteria

Exclusion Criteria:

* acute myocardial infarction
* unprotected left main stenosis
* chronic total occlusion
* saphenous vein graft lesion
* cardiomyopathy
* severe valvular heart disease
* NYHA functional class IV heart failure at baseline
* chronic renal failure on hemodialysis
* severe lung and liver disease or cancer
Pilot Study of Dexmedetomidine Sublingual Film for the Ambulatory Treatment of Hyperadrenergic Autonomic Crisis in Patients With Familial Dysautonomia

This is a pilot open-label study to evaluate the feasibility of conducting a clinical trial using sublingual dexmedetomidine sublingual film to treat hyperadrenergic autonomic crises in patients with Familial Dysautonomia at home. The primary aims are to examine the feasibility of performing a clinical trial using dexmedetomidine at home to terminate autonomic crisis, and refine the interventions and assessments used to evaluate autonomic crisis termination.


Eligibility Criteria:
Inclusion Criteria:

* Genetically confirmed diagnosis of Familial Dysautonomia.
* Evidence of autonomic crisis, previous treatment with IV dexmedetomidine without significant side effects, and registered medical data within the year preceding the study in our database.
* One or more autonomic crises during the last year.
* Age above 18 years.
* The patient has a responsible caretaker to communicate with the medical providers.
* Provision of signed and dated informed consent form from the patient and responsible caregiver.
* Able to state willingness to comply with all study procedures and availability for the duration of the study
* For males and females of reproductive potential: use condoms for contraception if sexually active.

Exclusion Criteria:

* At the consideration of the principal investigator, the caregiver cannot fully understand the protocol or communicate during the crisis with the Center.
* The patient during the crisis, before taking the medication, has any of the following:
* a. Oxygen saturation less than 92% on room air or baseline need for oxygen, change from baseline oxygen dependency.
* b. Respiratory rate \>20 breaths per minute.
* c. Supine blood pressure ≤ 90/60mmHg
* d. Febrile illness with temperature \>100.3 F.
* e. Serological signs of infection (WBC count \>10 g/dL, or CRP \>10 mg/L or ESR\>20, or above their steady historical baseline levels) in recent (less than one month) studies.
* The patient is a female and has a positive pregnancy test.
* MoCA score \<25 points.
Validation of the French Translation of the Scale HSCL25 in the Diagnosis of Depression in Primary Care

Depression has emotional consequences, social and important business. Reaching at least 7.5% of French aged 15 to 85 years. General Practitioners are the first professional consulted in terms of frequency of consultations. Indeed, in primary care, 10 to 25% of patients with depression that General Practitioners are often alone to support and follow. But General Practitioners are faced with diagnostic difficulties facing the diagnosis of depression, because if the patient does not engage itself, no tool is validated in France to help them in their diagnosis. However, standardized questionary exist that allow to overcome this difficulty. Questionary used in other european countries. Among them, the HSCL25 scale was selected by a systematic review of literature and a RAND UCLA type of consensus procedure. This HSCL25 scale is the most efficient for the diagnosis of depression in terms of efficiency tool, reproducibility and ergonomics. However, it remains necessary to confirm its validity in terms of the French translation and in terms of efficiency.


Eligibility Criteria:
Inclusion Criteria:

* Adult (18 and over) consultant in primary care

Exclusion Criteria:

* Child or young person under 18
* Women with a declared pregnancy to prevent puerperal depression whose support is different.
* Adult consultant to obtain a medical certificate
* Psychotic patients and\\or requiring immediate care
Pulmonary Embolism in Pregnancy: Biomarkers and Clinical Predictive Models

Objective: To evaluate whether trimester specific d-dimer levels and brain natriuretic protein (BNP), along with the modified Wells score (MWS), is a useful risk stratification tool to exclude pregnant women at low-risk of pulmonary embolism (PE) from diagnostic imaging with radiation exposure.

To account for all women meeting the study eligibility criteria, this study utilized a combined prospective and retrospective arm. Pregnant women who underwent diagnostic imaging to evaluate for suspected PE at our institution were prospectively enrolled from February 2014 to August 2015. Both d-dimer and BNP serum levels were drawn, and a MWS was assigned. All pregnant women diagnosed with a PE that underwent diagnostic imaging and had a d-dimer level drawn from January 2009 to June 2014 were retrospectively enrolled. Patient electronic records were used to apply the MWS and analyze their risk.

Eligibility Criteria:
Inclusion criteria:

* adult pregnant women \>= 18 years old
* d-dimer obtained and if the patient was pregnant at the time of PE diagnosis
* patient presented to the Emergency Department or Labor and Delivery unit
* patient presented with signs and symptoms suspicious for PE

Exclusion criteria:

* non-pregnant patients
* patients \< 18 years old