cyrilzakka/clinical-trials huggingface dataset:
Effect of Physical Training Combined Cardiac Resynchronization Therapy in Heart Failure Patients

The investigators hypothesis that exercise training would potentiate the effects of cardiac resynchronization therapy in heart failure patients.


Eligibility Criteria:
Inclusion Criteria:

* QRS\> 150 ms or 120-150ms associated dyssynchrony
* The etiology can be idiopathic, ischemic, hypertensive and Chagas' disease
* Ejection fraction \<35%
* The optimal pharmacological treatment for heart failureExclusion Criteria:

Exclusion Criteria:

* Patients with pulmonary diseases, neurological diseases, renal, skeletal muscle diseases
* Patients with contraindications to implant a cardiac pacemaker
* Pregnancy
* New York Heart Association functional class IV
* Atrial fibrillation
Understanding the Role of Sleep in Complicated Grief

The purpose of this study is to learn more about the causes of Complicated Grief (CG) in those who experience the loss of a loved one. This study aims at learning more about the sleep patterns and emotions in participants with CG as compared to those who have lost a loved one but do not have CG.

This study will consist of two aims:

Aim 1: Approximately 10 complicated grief (CG) patients and 10 controls (without a current psychiatric diagnosis) will complete a 3-day home polysomnography (PSG) sleep assessment in addition to several self-report sleep and psychiatric measures.

Aim 2: Approximately 10 CG patients (subsample from Aim 1) will complete 16 weekly sessions of complicated grief therapy (CGT) in addition to completion of repeated PSG assessments and self-report sleep and psychiatric measures.


Eligibility Criteria:
Inclusion Criteria:

* Bereaved due to death of a loved one \>= 6 months prior (for both CG and control groups)
* For CG participants: grief is primary psychiatric problem with ICG \>= 30 (threshold symptoms; for CG group only). Controls will be free of current psychiatric disorders with the exception of specific phobia.
* Normal or corrected vision

Exclusion Criteria:

* Psychiatric or sleep medications in the past 4 weeks (past 6 weeks for fluoxetine)
* Concurrent grief or exposure based therapy
* Lifetime bipolar, psychosis, significant neurological disorders
* Past 6 months of alcohol/substance use disorder
* Unstable medical illness
* Serious safety concerns of suicide or homicide
* Pregnant or nursing
* Overnight shift work
* \> 4 caffeinated or \> 11 alcoholic beverages per week
* Screening reveals OSA defined as an apnea hypopnea index with 4% desaturation (AHI4%) ≥15 or an AHI4% ≥ with an Epworth \>10
Echocardiographic Markers of Atrial Fibrillation Recurrence Post Radiofrequency Ablation

Determine echocardiographic predictors of atrial fibrillation recurrence post radiofrequency Ablation and evaluate markers of low voltage areas on 3D mapping.


Eligibility Criteria:
Inclusion Criteria:

* paroxysmal or persistent ablation

Exclusion Criteria:

* previous AF ablation
* previous left atrial ablation
* refusal to give informed consent
* congenital cradiomiopathy
An Open-label Extension Study of Canakinumab in Patients With Systemic Juvenile Idiopathic Arthritis and Active Systemic Manifestations Manifestations and Response Characterization Study in Canakinumab Treatment-naïve Patients With Active SJIA With and Without Fever.

This open-label extension study will permit patients with Systemic Juvenile Idiopathic Arthritis (SJIA) who previously were responsive to treatment with canakinumab and canakinumab treatment-naïve patients with active SJIA with and without fever to be retreated with 4 mg/kg s.c. every 4 weeks and assessed for continued efficacy and safety until discontinuation or when study CACZ885G2402 is in place at their study center or around March 2013, whichever occurs first. Patients who are steroid-free will be able to taper their canakinumab dose to 2 mg/kg s.c. every 4 weeks.


Eligibility Criteria:
Inclusion criteria:

* Patients from study CACZ885G2305 or CACZ885G2301 who achieved an adapted ACR pediatric 30 response 15 days after their initial dose of canakinumab but clinically deteriorated afterwards or a minimum ACR Pediatric 30 response was not maintained after Day 15 and intervention is deemed necessary by the investigator, or Patients in study CACZ885G2301 who are not eligible to enter Part II (withdrawal part) because they were not able to meet the corticosteroid entry criteria , or Responder patients in Part I or Part II who had not flared when CACZ885G2301 was stopped, or CACZ885G2301 patients who were responders in Part I but experienced a flare in Part II.
* Treatment-naïve patients need to meet the following criteria:

  * Confirmed diagnosis of systemic juvenile idiopathic arthritis as per ILAR definition that must have occurred at least 2 months prior to enrollment with onset of disease \< 16 years of age
  * Male and female patients aged ≥ 2 to \< 20 years of age
  * Active disease at the time of enrollment defined as having 2 or more of the following:

    * Documented spiking, intermittent fever (body temperature \> 38°C) for at least 1 day during the screening period and within 1 week before first canakinumab dose
    * At least 2 joints with active arthritis
    * AND C-reactive protein (CRP) \> 30 mg/L (normal range \< 10 mg/L) Rash Serositis Lymphadenopathy Hepatosplenomegaly
  * Naïve to canakinumab

Other protocol-defined inclusion criteria may apply

Exclusion criteria:

* History of allergy or hypersensitivity to study drug
* With active or recurrent bacterial, fungal or viral infections at time of enrollment

Other protocol inclusion/exclusion criteria may apply
A Comparison of High-dose Dual Therapy and Half-dose Clarithromycin-containing Bismuth Quadruple Therapy for H.P Eradication in Elderly Patients

The purpose of this study is to assess and compare the effectiveness and safety of high-dose dual therapy and half-dose clarithromycin-containing bismuth quadruple therapy in elderly patients for eradicating H.pylori.

Helicobacter pylori plays an important role in many diseases such as peptic ulcer disease and MALT lymphomas. And the prevalence of H. pylori remains high in developing countries,including China.

Clarithromycin-containing bismuth quadruple therapy has been recommended as the first-line therapy for H pylori infection in China. However, its expensive cost and high antibiotic-related adverse reactions are always haunting us. In 2018,a research from NanFang hospital(China）revealed that 250mg clarithromycin is as effective as 500mg clarithromycin，at the same time，causes less adverse reactions. On the othe hand,previous studies reported a new regimen called large dose dual therapy（generally contains a PPI and amoxicillin),while some of them have achieved very good results,especially in Taiwan.

However, specific data on anti-H.pylori treatments in elderly people are very lacking.So,we aim to assess and compare the effectiveness and tolerability of high-dose dual therapy and half-dose clarithromycin-containing bismuth quadruple therapy in elderly patients.Considering the difference of drug metabolism between eldery and young people，a satisfactory result may be obtained.

Eligibility Criteria:
Inclusion Criteria:

* Patients, aged greater than 65 , with positive H. pylori infection that was not eradicated by previous therapies are included. The H. pylori infection is confirmed by the positive rapid urease test or 13C-breath test.

Exclusion Criteria:

* Patients with significant underlying disease including liver, cardiac, pulmonary, and renal diseases, neoplasia, coagulopathy and genetic diseases, history of gastric surgery, pregnancy, breast-feeding, active gastrointestinal bleeding, the use of PPI, NSAID or antibiotics during the 4 weeks prior to enrolment, and previous history of allergic reactions to any of the medications used in this protocol. Patients previously treated with H. pylori eradication regimens or those unwilling to participate in the study were also excluded.
Safety/Efficacy of Nepafenac Punctal Plug Delivery System Compared to Placebo to Control Ocular Pain/Inflammation After Cataract

This is a Phase 2, multi-center, randomized, parallel-arm, double-masked, placebo-controlled study. One (1) to 2 days prior to their scheduled cataract surgery, each study subject will be randomized (2:1) in to one of two treatment groups: N-PPDS or p-PPDS, which are inserted in the lower punctum of the subject's scheduled surgical eye. All plugs will remain in the study subject's lower punctum for a period of 2 weeks following cataract surgery.

This is a Phase 2, multi-center, randomized, parallel-arm, double-masked, placebo-controlled study. One (1) to 2 days prior to their scheduled cataract surgery, each study subject will be randomized (2:1) in to one of two treatment groups:

Group A: A total of 50 study subjects (50 eyes) will have an N-PPDS inserted in the lower punctum of their scheduled surgical eye.

Group B: A total of 25 study subjects (25 eyes) will have a p-PPDS inserted in the lower punctum of their scheduled surgical eye.

All plugs will remain in the study subject's lower punctum for a period of 2 weeks following cataract surgery.

Eligibility Criteria:
Inclusion Criteria:

1. A male or female subject in good general health, ≥ 22 years of age at the time of the screening visit
2. A subject with a cataract for which routine phacoemulsification extraction and implantation of an intraocular lens has been planned
3. A subject has a lower puncta that can be dilated to 1.0 mm in their scheduled surgical eye

Exclusion Criteria:

1. A subject with a history of complications, adverse events, trauma or disease in the nasolacrimal area, whether or not it was due to punctal plug wear, including but not limited to dacryocystitis, inflammation or canaliculitis in either eye
2. A subject with structural lid abnormalities (e.g., ectropion, entropion) in their schedule surgical eye
3. A subject with a puncta \>0.9 mm prior to dilation in their scheduled surgical eye
4. A subject with any signs of intraocular inflammation (cells/flare) in either eye at the screening visit
5. A subject with a known sensitivity to nepafenac or any inactive ingredient of the punctum plug, silicone, fluorescein, topical anesthetic, or any other products required for study procedures or cataract surgery
6. A subject with a history of chronic/recurrent inflammatory eye disease (e.g., scleritis, uveitis, herpes keratitis) in either eye
Can Lifestyle Changes Reverse Early-Stage Alzheimer's Disease

The objective of this study is to determine if comprehensive lifestyle changes may slow, stop, or reverse the progression of early-stage Alzheimer's disease.

51 patients who have early Alzheimer's disease (MoCA above 17) in the San Francisco Bay area were enrolled over time and are randomly assigned to one of two groups.

After baseline testing, the first group then receives this lifestyle medicine program for 20 weeks, four hours/day, three days/week (all done virtually via Zoom since March 2020 due to COVID-19).

The second group will not receive the lifestyle program for 20 weeks and will serve as a randomized control group during this phase of the study.

Both groups will be re-tested after 20 weeks.

Then, the second group will "cross over" and receive this lifestyle medicine program for 20 weeks and the first group will continue the lifestyle program for 20 additional weeks. After a total of 40 weeks, both groups will be re-tested again and compared. Those initially randomly assigned to the control group will receive the intervention for 40 weeks and then be re-tested at that time.

Eligibility Criteria:
Inclusion Criteria:

* Current diagnosis of mild dementia or mild cognitive impairment due to Alzheimer's disease/process (McKhann and Albert criteria), with MoCA score above 17 (i.e., 18 or higher)
* Willingness and ability to participate in all aspects of the intervention
* Availability of spouse or caregiver who can provide collateral information and assist with study adherence

Exclusion Criteria:

* severe dementia
* physical disability that precludes regular exercise
* clear evidence for other causes of neurodegeneration or dementia, e.g., severe cerebrovascular disease, Parkinson's disease
* significant ongoing psychiatric or substance abuse problems
Protein Supplements in Association With Prehabilitation Program for Cancer Patients Before Surgery

The aim of study is to analyse the feasibility of the use of nutritionnal complements after exercices before surgery for cancer.

Body composition, muscle function and muscle mass will be analyse too.

A prospective study will be carried out including adult patients with neoplasia who should benefit in their therapeutic strategy from oncological surgery. About fifty patients will be recruited in the oncology / surgery department at the Saint-Luc University Clinics in Brussels. Patients will be assessed at the initial consultation and after the pre-habilitation period, ie the day before the operation.

Dietary monitoring will be carried out in parallel with a physical and respiratory preparation program (prehabilitation) and the intake of protein nutritional supplements in the form of powder to be diluted will be carried out after each exercise session.

Eligibility Criteria:
Inclusion Criteria:

* patient with operable cancer
* patient inform consent
* min 18 years old
* french or english speaking

Exclusion Criteria:

* neuromuscular pathology
* cardiorespiratory or orthopedic pathology that prevents physical activity
* cognitive or psychiatric disorders
ACE1702 in Subjects With Advanced or Metastatic HER2-expressing Solid Tumors

ACE1702 (anti-HER2 oNK cells) is an off-the-shelf Natural Killer (NK) cell product that targets human HER2-expressing solid tumors. The ACE1702-001 phase I study aims to evaluate the safety and tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of ACE1702 in patients with advanced or metastatic HER2-expressing tumors, and to determine the phase Ib/II starting dose for ACE1702.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Subjects must be ≥ 18 years of age ( ≥ 20 years of age for Taiwan site)
* Subject with advanced or metastatic solid tumors that is not amenable to surgical resection and is not eligible or has refused other approved therapeutic options that have demonstrated clinical benefit.
* Histologically confirmed HER2 expression.
* Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1
* Measurable or non-measurable evaluable disease according to RECIST 1.1
* Adequate hematologic and end-organ function at baseline
* Oxygen saturation via pulse oxygenation ≥ 90% at rest on room air

Exclusion Criteria:

* Untreated central nervous system (CNS) metastases
* Multiple primary malignancies
* Clinically significant cardiovascular disease such as New York Heart Association (NYHA) cardiac disease (class III or greater)
* Pregnant or lactating female
* Serious, uncontrolled medical disorder that, in the opinion of the Investigator, would impair the ability of the subject to receive study treatment
* History of autoimmune or immune mediated symptomatic disease
* Any anti-cancer chemotherapy or targeted small molecule therapy, or experimental therapy/device within 4 weeks or 5 half-lives of the drug prior to planned start of the study
Da-vinci sp Versus xi Thyroid Surgery

One year comparative analysis between SPRA\* versus BABA\*\* thyroid surgery. \* SPRA: da-Vinci SP Robotic Areolar approach thyroid surgery

\*\* BABA: da-Vinci Xi robotic Bilateral. Axillary Breast Approach thyroid surgery

Study design: retrospective data analysis Study period: December 2022 to December 2023 Candidate: Patients who received robot thyroid surgery during study period Numbers of candidates: total of 270 patients Group : SPRA (n=111) versus BABA (n=159) Statistic analysis: t-test for continuous variable, fisher's exact test for categorical variable

Eligibility Criteria:
Inclusion Criteria:

* Patients who received robot thyroid surgery in our institution
* Retrospective review

Exclusion Criteria:

* N/A
A Study of the Safety and Efficacy of Bimatoprost Ophthalmic Solution in Paediatric Patients With Glaucoma

The purpose of this study is to assess the safety and efficacy of a new formulation of bimatoprost ophthalmic solution compared to timolol ophthalmic solution in the treatment of paediatric patients with glaucoma.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of congenital, juvenile glaucoma
* Requires treatment with IOP-lowering medication in one or both eyes

Exclusion Criteria:

* Surgical intervention is indicated or planned to lower IOP
* Abnormally low body weight (below 5th percentile)
* Any active eye infection or disease
* Anticipated use of contact lenses during the study
* Topical ocular steroid use within 2 months
* History of ocular trauma in either eye
* Required chronic use of ocular medications (other than study medication) during the study (intermittent use of artificial tears permitted)
Programs To Support You During Chemotherapy

This randomized pilot trial studies how well two supportive programs work for improving fatigue and depressive symptoms in patients with GI undergoing chemotherapy. Possible mediators such as psychological stress, circadian disruption, and inflammation, will also be explored.

PRIMARY OBJECTIVES:

I. To conduct a pilot randomized controlled trial of the yoga skills training (YST) versus a caring attention control (AC) group among adults with colorectal cancer (CRC) receiving chemotherapy to determine preliminary efficacy for the primary outcome of fatigue, secondary outcome of depressive symptoms, and possible mediators (i.e., psychological stress, circadian disruption, inflammation) as assessed by standard measures.

SECONDARY OBJECTIVES:

I. To measure the impact of the YST versus the AC on daily assessments of fatigue, depressive symptoms, and proposed mediators in the same trial and explore relationships among daily and standard assessments.

II. To qualitatively assess perceived efficacy of the YST and AC and acceptability of new methodology through semi-structured interviews in a subset of 20-40 participants.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I (YST): Patients participate in YST consisting of four 30 minute in-person yoga sessions at weeks 2, 4, 6, and 8 that instructs skills to enhance mindfulness and promote relaxation, through instruction of awareness, movement, breathing practices, and meditation.

GROUP II (AC): Patients participate in four 30 minute in-person sessions of supportive conversation at weeks 2, 4, 6, and 8.

After completion of study, patients are followed up at 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled to receive first-line Fluorouracil (5FU)-based intravenous chemotherapy treatment for a gastrointestinal cancer (stages II-IV)
* Have an Eastern Cooperative Oncology Group performance status of =\< 1
* Ability to understand and the willingness to sign and informed consent document in English

Exclusion Criteria:

* Has a self-reported history of diagnosed uncontrolled obstructive sleep apnea (ok if using CPAP), sleep-related seizures, sleep walking more than one time per week, restless leg syndrome, or a job with night shifts
Albumin for Hepatocellular Carcinoma

The rate of liver cirrhosis is about 40% to 75% among patients with hepatocellular carcinoma (HCC). Therefore, many patients with HCC were with low serum albumin before and after (especially) hepatic resection. Serum albumin level has been routinely used in clinical practice as a surrogate marker to evaluate nutritional status and liver function. Serum albumin concentration is used as an independent mortality risk predictor in a broad range of clinical and research settings. However, the role of albumin infusion in patients with hepatocellular carcinoma (HCC) after resection is unknown. The present study aimed to investigate the safety and clinical necessity of albumin infusion for HCC patients after hepatic resection.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index \>18.5;
* Patients with primary hepatocellular carcinoma without any treatments for tumors before resection;
* Hepatocellular carcinoma should be confirmed by histopathology;
* With preserved liver function (Child-Pugh score ≤7) before resection
* ECOG performance score 0 or 1;
* Preoperative serum albumin \>35g/L;
* The level of postoperative serum albumin is between 25-30g/L in the first day after resection.

Exclusion Criteria:

* Patients used albumin before liver resection (\<1 months);
* Plasma was used during or after liver resection;
* Surgery involving the extrahepatic bile duct or gastrointestinal tract.
Topical Morphine for Stomatitis-related Pain Induced by Chemotherapy

Stomatitis/oral mucositis is a common side effect to chemotherapy. Stomatitis is often associated with painful ulcers in the mouth. The study hypothesis is that morphine administrated as a mouthwash can relieve stomatitis-related pain by a local analgesic effect.

The purpose of this study is to test the analgesic effect of a morphine mouthwash versus morphine injections or placebo (no active drug) in children/adolescents with stomatitis related to chemotherapy. Besides the investigational drugs (morphine mouthwash and morphine injections) the children/adolescents receive a standardized analgesic treatment for stomatitis-related pain.


Eligibility Criteria:
Inclusion Criteria:

* Children and adolescents at The Juliane Marie Center at Copenhagen University Hospital (Rigshospitalet, Denmark) or at The University Hospital in Lund (Sweden)
* Receiving chemotherapy in relation to a cancer disease
* Pain score of minimum 3 (VAS-scale) at rest for mouth pain in combination with stomatitis of minimum grade 1 (WHO-scale) or a pain score of minimum 5 (VAS-scale) at activity for mouth pain in combination with stomatitis of minimum grade 1 (WHO-scale)
* Negative pregnancy test, when relevant (judged by physician)
* Patients and/or parents understand and speak danish (Denmark) / swedish (Sweden)
* Signed informed consent

Exclusion Criteria:

* Allergic to the investigational medical product
* Alcohol or drug abuse
Effects of Mid-Season Camp Period Loading on Sports Injury Anxiety and Physical Performance

The aim of this study is to investigate the effects of 3-week mid-season camp period loading on sports injury anxiety level and physical performances of professional male soccer players.

According to the periodization theory, the seasonal training process of soccer players is divided into four periods such as pre-season, early competition, late competition, and transition. In general, these periods aim to prepare soccer players for the competitive season, improve their fitness and physical performance, and reduce the risk of sports injuries. Therefore, the loading applied to soccer players during these camp periods are the key determinants of physical performance enhancement and the control of sports injury risks. In particular, the mid-season camp period loading is an important requirement to maintain the gains obtained in the pre-season training programs throughout the season. In this context, sports clubs prefer regions with different physical conditions (sea level, high altitude etc.) for the camp periods and allocate serious budgets for this periods.

Previous studies largely focused on effects of the pre-season camp period on psychological state and physical performance in soccer players. However, few studies in the current literature focused on the mid-season camp period. To the best of authors knowledge, sports injury anxiety and physical performance responses to the mid-season camp period loading in professional soccer players has not been very well discussed. Therefore the aim of this study is to investigate the effects of 3-week mid-season camp period loading on sports injury anxiety level and physical performances of professional male soccer players.

Eligibility Criteria:
Inclusion Criteria:

* volunteering to participate in study
* not have any musculoskeletal disease

Exclusion Criteria:

* using any drugs or supplements
* with a history of moderate to major injury within last 6 months
* having any systemic disease