cyrilzakka/clinical-trials huggingface dataset:
LIFE Study - Limiting Chronotropic Incompetence for Pacemaker Recipients

This study will compare how two different sensors inside the pacemaker may affect patients' quality of life.

The LIFE Study will estimate the prevalence of CI among a general sample of pacemaker patients and compare changes in quality of life and physical activity between patients randomized to receive rate response driven by either blended sensor or accelerometer. Changes in chronotropic response between CI patients randomized to either blended sensor or accelerometer will be compared. A sub-study will evaluate changes in functional capacity between CI patients randomized to either blended sensor or accelerometer.

Eligibility Criteria:
Inclusion Criteria:

* Patients who meet current INSIGNIATM Plus pacemaker indications
* Patients who sign and date a Patient Informed Consent prior to device implant
* Patients who remain in the clinical care of the enrolling physician

Exclusion Criteria:

* Patients whose previous pacemaker had a minute ventilation sensor
* Patients who have neuromuscular, orthopedic, or vascular disability that prevents normal walking (e.g., intermittent claudication, arthritis, residual stroke weakness, need for a wheelchair or walker)
* Patients in whom a symptom-limited exercise protocol is thought to be dangerous because of coronary artery disease or other cardiac disease
* Uncontrolled arrhythmias (e.g., chronic atrial fibrillation, frequent/persistent atrial fibrillation, ventricular arrhythmias, or patients with ablate and pace whose arrhythmia continues to be uncontrolled)
* Patients whose medical condition is expected to preclude the use of the protocol-required primary pacing mode (i.e., DDD or DDDR)
* Patients whose life expectancy is less than 12-months due to other medical conditions
* Patients who have or who are indicated for an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy-defibrillator (CRT-D)
* Patients who have active chronic leads that are either single-pass VDD, unipolar ventricular and atrial, non-IS-1, and non-3.2mm UNLESS the leads are replaced with bipolar leads that are IS-1/3.2mm compatible
* Patients who are currently enrolled in another investigational study that would directly impact the treatment or outcome of the current study. Each instance should be brought to the attention of Guidant's Clinical Application Research Studies (CARS) group to determine eligibility
* Patients who are younger than 18 years of age
* Patients who are pregnant
* Patients who are mentally incompetent and cannot sign a Patient Informed Consent or participate in the study
Incidence of Difficult Airway and Difficult Neuraxial Placement in Obstetric Patients

Anesthesiologists commonly administer pain relief during labor or providing anesthesia for cesarean delivery. Two main methods are used to achieve these goal: "Regional anesthesia" where the mother is given medication through a needle or catheter in her back and the mother is kept awake, or "General anesthesia", where the mother is given intravenous medication and is kept asleep.

Regional anesthesia uses a needle to enter a narrow space in the mother's back where medications can be given. In some patients, it takes longer to find this target space in the back. In emergency situation, however, there is often little time to find this space, and the backup method would be the general anesthesia technique.

If general anesthesia is required, a breathing tube needs to be inserted to help support the mother's breathing. In some patients, it is harder to insert the breathing tubes, so knowing this in advanced helps anesthesiologists create a safe plan for the patients. A lot of research has been done to determine factors that would predict which patients would need more time and preparation for general anesthesia and regional anesthesia.

The purpose of this study is to study how common it is for the pregnant patients who have a difficult regional and general anesthesia.

Anesthesiologists commonly administer pain relief during labor or providing anesthesia for cesarean delivery. Two main methods are used to achieve these goal: "Regional anesthesia" where the mother is given medication through a needle or catheter in her back and the mother is kept awake, or "General anesthesia", where the mother is given intravenous medication and is kept asleep.

Regional anesthesia uses a needle to enter a narrow space in the mother's back where medications can be given. In some patients, it takes longer to find this target space in the back. In emergency situation, however, there is often little time to find this space, and the backup method would be the general anesthesia technique.

If general anesthesia is required, a breathing tube needs to be inserted to help support the mother's breathing. In some patients, it is harder to insert the breathing tubes, so knowing this in advanced helps anesthesiologists create a safe plan for the patients. A lot of research has been done to determine factors that would predict which patients would need more time and preparation for general anesthesia and regional anesthesia.

The purpose of this study is to study how common it is for the pregnant patients who have a difficult regional and general anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant woman presenting for vaginal or cesarean delivery

Exclusion Criteria:

* Pregnant woman presenting for vaginal or cesarean delivery requiring urgent or emergent delivery
A Trial to Evaluate Safety and Efficacy of RP-L401-0120 in Subjects With Infantile Malignant Osteopetrosis

The primary objective of this Phase 1 study is to evaluate the therapeutic safety and feasibility of the investigational product (IP), RP-L401.

This is a non-randomized Phase 1 study to evaluate the preliminary safety and efficacy of hematopoietic gene therapy consisting of autologous CD34+ enriched hematopoietic cells transduced with the lentiviral vector (LV) carrying the human TCIRG1 transgene (RP-L401) in pediatric patients with IMO. Following myeloablative conditioning patients will receive an infusion of the genetically modified hematopoietic stem and progenitor cells (HSPCs).

Eligibility Criteria:
Inclusion Criteria:

1. A confirmed diagnosis of IMO with documented TCIRG1 mutation.
2. Age at least 1 month with minimum weight of 4 kg
3. Absence of debilitating hydrocephalus (defined as hydrocephalus at NCI CTCAE v5.0 Grade 3 or higher persisting despite shunt or similar procedural intervention).
4. Lansky Play Scale of at least 60%
5. Preserved hepatic function (AST/ALT ≤3.0 ULN; bilirubin ≤1.5 ULN; to minimize potential for excessive toxicity from busulfan conditioning)
6. No concomitant medical or other conditions that would represent a contraindication to autologous hematopoietic stem cell transplant.
7. Absolute neutrophil count of ≥500/mm3 and platelet count of ≥25,000/mm3
8. No prior allogeneic or other hematopoietic stem cell transplant.
9. Availability of a non-autologous rescue (back-up) hematopoietic stem cell donor/source

Exclusion Criteria:

1. Availability of medically-feasible HLA-matched sibling donor for allogeneic HSCT.
2. Any medical or other contraindication for either apheresis or autologous transplant as determined by the Investigator.
3. Participation in another clinical trial with an investigational drug within 14 days before the informed consent signature. Participation in observational studies is allowed.
4. Active hematologic or solid organ malignancy, not including non-melanoma skin cancer or another carcinoma in situ.
5. Uncontrolled seizure disorder.
6. Renal dysfunction as defined by a glomerular filtration rate \<30 mL/min/1.73m2 or dialysis dependence.
7. Serious infections with persistent bloodstream pathogens at time of trial entry
8. Pulmonary dysfunction as defined by either:

   * Need for supplemental oxygen during the prior 2 weeks (in absence of acute infection) or
   * Oxygen saturation (by pulse oximetry) \<90% resulting from pulmonary conditions (intermittent hypoxia secondary to IMO-related choanal atresia will not be considered exclusionary)
Latin American Survey of Nutrition and Health / Estudio Latinoamericano de Nutrición y Salud

This study aims to make a proper scientific assessment on the dietary intake and physical activity levels of a representative sample of the urban population of 8 Latin American countries (Argentina, Brazil, Chile, Colombia, Costa Rica, Ecuador, Perú and Venezuela). The study was based on complex, multistage sample design, stratified by conglomerates, being all regions of each country represented, and random selection of main cities within each region according to probability proportional to size method. Sample will be stratified by gender, age (15 to 65 years old), and socioeconomic level. Socioeconomic levels will be balanced and divided in three strata (high, medium and low) based on national indexes used in each country. All the study sites are university-based and will adhere to a common study protocol for training, implementation of fieldwork, data collection and management, and quality control procedures to be performed simultaneously. All participants will be required to provide a written informed consent. A pilot study at small scale will be performed in each country in order to test procedures and tools involved in ELANS. Anthropometric variables, including body weight, height, waist, hip and neck circumferences will be measured according to a standardized protocol. Nutritional intake evaluation will be performed using two 24-hour dietary recalls, with 'multiple pass' procedure and a food frequency questionnaire. Nutritional data will be entered in Nutrition Data System for Research (NDS-R, Minnesota University) after a harmonization process between local foods and NDSR database. Physical activity and energy expenditure will be assessed by IPAQ-long version questionnaire and 7-day accelerometry.


Eligibility Criteria:
Inclusion Criteria:

* males and females
* 15 to 65 years old

Exclusion Criteria:

* Adolescents without assent and parent´s or legal guardian´s permission will be excluded
* Any adolescent or adult with mental and/or physical disability will be excluded.
* Any adolescent or adult with a chronic or acute illness that may affect normal eating behavior or energy expenditure will be excluded.
* Pregnant and nursing women of a child younger than 6 months will be excluded.
* Any adolescent or adult who is not able to read will be excluded.
* Any adolescent or adult who is not present at or refuses to accept the second visit will be excluded.
* Any adolescent or adult living in any residential settings different from a household (hospitals, regiments, homes, such as old-age homes, etc.) and mobile homes or trailers are excluded.
Non-Interventional Study to Examine Rituximab Treatment in Follicular Lymphoma Participants

It is a non-interventional study with a duration of approximately 24 months per participant to investigate the therapeutic efficiency, safety and treatment regimens of Rituximab maintenance therapy in daily routine in participants with previously untreated, relapsed or refractory cluster of differentiation 20 (CD20)-positive follicular lymphoma (FL) in clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years
* Previously untreated, relapsed or refractory CD 20-positive FL
* Responding to rituximab containing induction therapy (complete response \[CR\] or partial response \[PR\])
* To receive rituximab maintenance therapy (decision taken by doctor prior to and independent of this non-interventional study)
* No ineligibility for rituximab

Exclusion Criteria:

Not Applicable (NA)
Mobile Health Technology for Palliative Care Patients

To test the potential and acceptance of wireless activity tracking in palliative care patients leaving hospital care. Explorative study, collaboration project of the Clinic of Radiation-Oncology, University Hospital Zurich and the Wearable Computing Laboratory, Swiss Federal Institut of Technology. Patients receive a tracking bracelet and a smart phone in order to gather objective physical activity parameters as step count, sleep duration, heart rate, social activity patterns (e.g. making calls) as well as subjective ratings of pain and distress. Quality of life (QoL) will be captured by paper questionnaire. Correlations between patients' physical activity patterns and the pain and distress level assessed from electronic scales as well as QoL-questionnaire will be performed. Acceptance will be evaluated by quantitative questionnaires and interviews. The proposed study is meant to be preparatory work for an intervention study to test the effect of wireless monitoring of palliative care patients on fostering early interventions for symptom relief and support of QoL.


Eligibility Criteria:
Inclusion Criteria:

* established diagnosis of metastatic cancer or other severe illness with limited life-expectancy (physicians guess \<12 months, \> 8 weeks)
* Karnofsky Index ≥50%
* ECOG≤ 2
* aged \> 18 years
* passed a short handling test with devices (tracking bracelet, smart phone)

Exclusion Criteria:

* relevant cognitive impairment
* insufficient knowledge of German language.
Results of Suprachoroidal Steroids Injections in Two Chorioretinal Diseases

Suprachoroidal injection is a safe way for intraocular drug delivery. It was used to treat various retinal conditions.

Suprachoroidal triamcinolone acetonide injection is used to treat various retinal diseases, higher concentration of the injected material is found when the suprachoroidal space is used as an intraocular delivery pathway when compared to the conventional intravitreal pathway.

Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed as central serous chorioretinopathy and patients with cystoid macular edema due to irvine-gass syndrome after cataract surgery.

Exclusion Criteria:

* other retinal diseases that may affect CMT and final visual outcome.
* Patients with dense corneal opacity.
Bupivacaine 0.125% Versus Bupivacaine 0.25% in Superficial Cervical Plexus Block for Tympanomastoid Surgeries in Adults

Bleeding is one of the most common complications in tympanomastoid surgery that could prolong the time of operation and also might lead to morbidity. Pain is also one of the most annoying complications of tympanomastoid surgeries. Thus, adequate surgical field visualization is utmost important. A bloodless field allows optimal exposure and identification of vital neurovascular structures. Even small bleeding, inconsequential for the patient's volume status, can create great technical difficulty in the confined space of the tympan, leading to prolonged surgery, incomplete procedures, and increased complications.

The use of regional nerve blocks as an alternative to hypotensive anesthesia has gained popularity in recent years. The superficial cervical plexus block (SCPB) provides effective analgesia and reduces sympathetic activity, resulting in reduced bleeding and improved surgical conditions. The superficial cervical plexus (SCP) provides sensory innervation to the ear and surrounding structures, reducing pain perception during and after surgery.

This is the first randomized controlled clinical trial investigating the effect of combined general anesthesia with SCPB using 0.125% versus 0.25% bupivacaine during tympanomastoid surgery.

This study aims to compare the efficacy of two different concentrations of bupivacaine 0.125% \& 0.25% in Superficial Cervical Plexus Block in patients undergoing tympanomastoid surgery on operative field visualization, intraoperative hemodynamic stability, and postoperative analgesia.

The investigators hypothesize that bupivacaine 0.125% would be non-inferior to bupivacaine 0.25% in achieving optimal surgical field visualization, hemodynamic stability, surgeon satisfaction and postoperative analgesia.

This prospective double-blinded study will be carried out on 60 patients between 21 to 70 years, with ASA I-II and undergoing tympanomastoid surgery. Participants were equally divided into two groups: Group A: Patients received SCPB using 0.25% bupivacaine (5ml of bupivacaine 0.5% + 5ml normal saline). Group B: Patients received SCPB using 0.125% bupivacaine (2.5ml of bupivacaine 0.5% + 7.5ml normal saline).


Eligibility Criteria:
Inclusion Criteria:

1. Adults between 21 - 70 years.
2. Patients undergoing tympanomastoid surgery.
3. Both genders.
4. ASA physical class I and II.

Exclusion Criteria:

1. Patient refusal.
2. Uncooperative patients.
3. Allergy to the drug enrolled in the study.
4. Anatomical abnormality at injection site.
5. Infection at injection site.
6. Bleeding disorders.
7. ASA physical class III and IV patients.
8. Patients having significant chronic diseases as: uncontrolled asthma, cardiovascular disorders (significant arrhythmias, severe valvular diseases, congenital heart diseases, ischemic heart disease, or cardiomyopathy).
9. Renal impairment (creatinine level ≥ 2mg/dl), or uncompensated chronic liver disease.
ATEM (Alvesco Non-interventional Study)

The aim of the study is to evaluate the efficacy of Alvesco in patients with persistent asthma including or excluding allergic components over 3 months, especially in the spring season. Alvesco will be inhaled by a metered-dose inhaler. The study will provide further data on safety and tolerability of Alvesco .


Eligibility Criteria:
Main Inclusion Criteria:

* Asthma with or without allergic components

Main Exclusion Criteria:

* Hypersensitive to compounds of Alvesco
* Other criteria as defined in the Summary of Product Characteristics, Chapter 4.3
Effects of Two Doses of a Common Cold Treatment on Alertness

This study will investigate any improvement in alertness and performance based on cognitive function and mood assessment in subjects suffering the common cold, when taking a novel paracetamol and caffeine combination verses paracetamol alone.


Eligibility Criteria:
* Participants with symptoms of cold \< 96 hours, rating of at least '2' on malaise at least 4 other symptoms of cold.
* No history of clinically significant perennial rhinitis, no recent antibiotic, antihistamine or cold treatment, no caffeine in the previous 12 hours, no psychoactive medication in the 14 days prior to screening, no pregnancy, breastfeeding or participation in this trial, or another trial in the 30 days prior to screening.
Financial Incentives to Improve Asthma

The aim of this pilot randomised controlled trial is to assess the effectiveness of a short-term financial incentives intervention at bringing about behaviour change, namely short-medium term improvements in inhaled corticosteroid (ICS) adherence and asthma control in children and young people (CYP) with asthma.

After obtaining informed consent from parents (and assent from the CYP), CYP will be enrolled in a 24-week programme. All participants will receive an electronic monitoring device (EMD) which will be programmed with twice daily audio-visual reminders and will be required to download the EMD-associated App onto their smartphones. All participants will be required to attend 3 study visits at 0 weeks (baseline), 12-weeks and 24-weeks (follow-up).

At baseline participants will be assessed for inhaler technique and given an asthma action plan (if they do not have one already) and will be randomised to either the control group or the intervention group. Intervention period will run between study visit 1 (0-weeks) and study visit 2 (12-weeks). Over the intervention period, participants in the intervention group will use their EMD with reminders, but will also be given financial incentives dependent upon their daily adherence and will have access to some additional EMD-associated app features (including notifications, a reward totaliser and a traffic light calendar to monitor progress). Control group participants will receive their usual care plus the use of EMD with reminders over the intervention period.

After the intervention period (at study visit 2), intervention participants will no longer receive rewards or be able to access the additional app features. All participants (control and intervention) will be able to use their EMD with reminders for the final 12-week follow-up period.

After completion of the 24-week programme, all participants will be required to return their EMD devices and will be invited to a focus group to share experiences and feedback of the trial.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained from parent/guardian and assent from child.
* CYP with doctor diagnosed asthma presenting to Emergency Department (ED) with a severe asthma exacerbation (as defined by ERS/ATS guidelines).
* Aged between 11 and 17 years old
* Prescribed maintenance inhaled corticosteroids (ICS) (which can include maintenance and reliever therapy MART) for at least 6-months.
* Own their own mobile smartphone (running Android 8 or higher, or iOS 13 or higher)
* Prescribed the following inhalers: Clenil, Flixotide, Symbicort, Seretide

Exclusion Criteria:

* Parent/guardian / CYP unable to provide consent / assent
* CYP with other, co-existing respiratory conditions
* Parent/guardian/CYP who are not fluent or able to understand the information provided in English.
* CYP who are involved in other intervention research studies (including CTIMPs)
Ejaculatory and Orgasmic Dysfunction Registry

The goal of this observational study is to evaluate the safety and efficacy of various therapies used to treat ejaculatory and/or orgasmic dysfunctions in men. The objective is to create a large, national registry designed to capture key outcomes for men being treated for ejaculatory and/or orgasmic dysfunction.

Participants will submit questionnaires about their diagnosis and treatment efficacy and multiple time intervals.

The objective of the current study is to create a large, national registry designed to capture key outcomes for men being treated for ejaculatory and/or orgasmic dysfunction. To accomplish this registry, CURE PD has partnered with the Sexual Medicine Society of North America (SMSNA) to help inform sexual medicine providers of the existence of the study and to help encourage patients to enroll.

Subjects meeting criteria will be offered study entry by their local provider who will refer them to an email address to indicate their interest. Participants will then be administered questionnaires at baseline and every 3 months x 1 year, followed by every 6 months x 2 years. Patient partners will also be allowed to enroll and will receive questionnaires on the same schedule (baseline, q3 months x 1 year, q6 months x 2 years).

Eligibility Criteria:
Inclusion Criteria:

* Men being treated for either ejaculatory and/or orgasmic dysfunction
* For partners, inclusion is being a sexual partner of a man with ejaculatory and/or orgasmic dysfunction who is receiving treatment

Exclusion Criteria:

* None
12 Weeks of Resistance Band Exercise Impacts on Adiposity, Hormones, and Blood Pressure in Postmenopausal Women

The purpose of this study was to examine the impacts of a 12-week resistance band exercise program on body composition, aging-related hormones, and blood pressure in postmenopausal women with stage 1 hypertension. Twenty postmenopausal women with hypertension participated in this study. Participants were randomly allocated into the resistance band training group (EX, n = 10) or the control group (CON, n = 10). The EX group performed a resistance band exercise training program at jump rope training program at 40-70% of their heart rate reserve (HRR) 5 days/week for 12 weeks (sessions 60 minutes in duration). The CON group did not participate in any exercise, dietary, or behavioral intervention. Body composition, aging-related hormones (growth hormone, insulin-like growth factor 1, dehydroepiandrosterone, and estradiol), and blood pressure were measured before and after the 12-weeks study.


Eligibility Criteria:
Inclusion Criteria:

* postmenopausal
* hypertensive
* sedentary (no regular exercise training or physical activity within previous year)

Exclusion Criteria:

* premenopausal
* renal, pulmonary, and/or heart disease
* regularly physically active