cyrilzakka/clinical-trials huggingface dataset:
Effect of Citalopram on Chest Pain in Patients With Functional Chest Pain

Non-cardiac chest pain (NCCP) in the absence of musculoskeletal abnormalities, major esophageal motor disorders, gastroesophageal reflux or eosinophilic esophagitis is called functional chest pain (FCP). Most likely multiple factors play a role, such as esophageal hypersensitivity and enhanced perception. Citalopram and other antidepressants are proven to be effective in the treatment of functional gastrointestinal disorders such as irritable bowel syndrome. With this trial the investigators want to assess the effect of citalopram on symptoms of chest pain in patients with functional chest pain.

Chest pain can be divided in cardiac or non-cardiac chest pain (NCCP). To establish the diagnosis NCCP, acute coronary disease has to be ruled out first. NCCP can be caused by functional chest pain (FCP). NCCP in the absence of musculoskeletal abnormalities, major esophageal motor disorders, gastroesophageal reflux or eosinophilic esophagitis is called FCP. The pathophysiology is not fully understood. Most likely multiple factors play a role, such as esophageal hypersensitivity and enhanced perception. Citalopram and other antidepressants are proven to be effective in the treatment of functional gastrointestinal disorders such as irritable bowel syndrome. However, available data regarding low dose antidepressants in functional chest pain is inconclusive. Moreover, all current evidence concerning the effect of low dose antidepressants in patients with functional chest pain is extracted from trials that pooled patients with different functional esophageal disorders. With this trial the investigators want to assess the effect of citalopram on symptoms of chest pain in patients with functional chest pain.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Minimum age: 18 years
* Functional chest pain according to Rome IV criteria
* Ruled out cardiac origin of chest pain
* ECG with corrected QT interval (QTc) within the normal range (\<450ms male, \<460ms female)
* Symptoms of chest pain for at least 6 months
* Frequency of symptoms at least once a week
* Gastroduodenoscopy, high-resolution manometry and 24-hour pH-impedance monitoring need to have been performed recently.

Exclusion Criteria:

* Currently using antidepressants
* Contraindication for the use of SSRI
* Already tried antidepressants off-label to treat chest pain
* Known allergy to citalopram
* Severe and clinically unstable concomitant disease
* Pregnant, lactating or fertile women (without contraception)
A Study of Durvalumab as Consolidation Therapy in Non-Small Cell Lung Cancer Patients

This is a Phase III, randomised, double-blind, placebo-controlled, multicentre study assessing the efficacy and safety of durvalumab compared with placebo, as consolidation therapy in patients with locally advanced, unresectable, non-small cell lung cancer (Stage III), who have not progressed following definitive, platinum-based, chemoradiation therapy.

Approximately 400 patients will be randomized in a 2:1 to receive treatment with durvalumab or placebo therapy. The primary objective of this study is to assess the efficacy of durvalumab treatment compared with placebo in terms of PFS.

Eligibility Criteria:
Inclusion Criteria:

1. Age≥18 years
2. Documented NSCLC and present with locally advanced, unresectable (Stage III) disease;
3. Receipt of concurrent or sequential chemoradiation therapy,
4. No progression following definitive, platinum-based, concurrent or sequential chemoradiation therapy
5. World Health Organization (WHO) PS of 0 or 1;
6. No prior exposure to any anti CTLA-4, anti-PD-1, anti-PD-L1, or anti PD L2 antibodies, excluding therapeutic anticancer vaccines
7. Adequate organ and marrow function required
8. Life expectancy of at least 12 weeks
9. Tumor PD-L1 status, with the Ventana SP263 PD-L1 IHC assay determined by a reference laboratory, must be known prior to randomization.
10. Tumour sample requirements are as follows: Provision of a tumour tissue sample (newly acquired sample \<=3 months old is preferred, but an archived sample \<=6 months old is acceptable) in a quantity sufficient to allow for analysis.

Exclusion Criteria:

1. History of allogeneic organ transplantation, or another primary malignancy, or active primary immunodeficiency.
2. Active or prior documented autoimmune or inflammatory disorders
3. Uncontrolled intercurrent illness that would limit compliance with study requirement, substantially increase risk of incurring AEs, or compromise the ability of the patient to give written informed consent
4. Active infection including tuberculosis hepatitis B hepatitis C (HCV), or human immunodeficiency virus (positive human immunodeficiency virus \[HIV\] 1/2 antibodies).
5. Mixed small cell and NSCLC histology, sarcomatoid variant
6. Any unresolved toxicity National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥2 from the prior chemoradiation therapy.
7. Receipt of live attenuated vaccine within 30 days prior to the first dose of IP.
8. Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP.
Physiology of GERD and Treatment Response

This study is designed to assess the physiologic and behavioral mechanisms associated with enhanced medication effects in adult patients with functional GERD-related symptoms.

Subjects will complete questionnaires regarding their GERD-related symptoms and have a visit with a study clinician regarding their symptoms. Heart rate variability and galvanic skin response will be measured in the patient-provider dyads and the visits video recorded. Subjects will receive a two-month supply of amitriptyline (10 mg/day), along with instructions for taking it. Subjects will complete a daily GERD symptom diary during the first and eighth weeks of the study. At the end of the 8-week observation period, subjects will complete follow-up measures of GERD symptom severity and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Adults ages 24-64 years old
* Functional heartburn (defined as \<4% of time with reflux on 24 hour pH manometry) symptoms 3 or more days per week with an average daily symptom severity of 3 or more on a 7-day baseline symptom diary
* English language proficiency
* Willingness to be videotaped and connected to physiologic monitoring devices during the visit
* Willingness to take amitriptyline daily for 8 weeks following study visit 1

Exclusion Criteria:

* Diagnosis of Crohn's disease, systemic sclerosis, known active ulcer disease, gastric cancer, or untreated/active Barrett's esophagitis based on subject self-report and/or medical record review
* Heavy alcohol use (\> 6 drinks/week for women and \> 13 drinks/week for men) based on subject self-report
* Pregnant, attempting to become pregnant, or breast-feeding
* Dementia or significant memory difficulties as determined by the study team and medical record review
* Severe, unstable psychiatric disease based on subject self-report, study team determination, and/or medical record review
* Bipolar disorder, concurrent treatment with a SSRI or another antidepressant that interacts with tricyclic antidepressants
* Prolonged QTc or severe heart disease
* History of seizure disorder
* Severe liver impairment - e.g., cirrhosis, hepatocellular carcinoma, hepatitis
* Currently taking a tricyclic antidepressant, allergy to tricyclic antidepressants, or another medical contraindication to taking amitriptyline or related medications
* Greater than 15 doses of nonsteroidal anti-inflammatory drugs (NSAIDS) within the prior 30 days (aspirin ≤ 325 mg daily permitted) or ongoing NSAID use at a level deemed likely to interfere with the study
* Failure to complete the baseline symptom diary for at least 6 of 7 days
* Change in GERD treatment regimen within the last 2 weeks (subjects may use antacids, H2 receptor blockers, and/or proton pump inhibitors as long as they are symptomatic on a stable regimen)
* Allergy to adhesives
* Inability to provide informed consent
* In the opinion of the investigator, unable to comply with the study protocol or has a condition that would likely interfere with the study
Efficiency of an Educational Program for Informal Caregivers of Hospitalized, Dependent Patients: Cluster Randomised Trial

The aim was to assess whether nursing interventions based on Health Educational Programs for primary informal caregivers of dependent patients may improve their quality of life, decreasing emotional burden and increasing caregiving knowledge, in order to better meet patients' basic needs.


Eligibility Criteria:
Inclusion Criteria:

* Primary informal caregivers of dependent patients, admitted in 30 hospital units, with expected hospital stays of at least one week. A dependent patient is understood to require the aid of someone else in order to carry out basic daily activities.

Exclusion Criteria:

* caregivers with cognitive deficits that could be an obstacle for adequate verbal understanding, illiteracy, persons taking part in other clinical trials or who had taken part in similar workshops in the previous two years, as well as health professionals.
Mobile Health Self-Management and Support System for Chronic and Complex Health Conditions

This study will assess the benefits of using mobile health system designed for individuals with chronic and complex health conditions (such as those with Spinal Cord Injury,Cerebral Palsy, Spina Bifida, and Traumatic Brain Injury) to improve their wellness and self-management skills compared to those who receive standard of care only.

Individuals with chronic and complex conditions such as those with spinal cord injury (SCI),Cerebral Palsy (CP), Spina Bifida (SB), and Traumatic Brain Injury (TBI), often require complex self-management routines to manage various needs such as bowel and bladder, skin integrity, and general health and wellness. Tasks such as self-catheterization, bowel regimens, skin checks, and routine administration of medications require consistent follow-through to prevent complications. Early detection and treatment of problems such as urinary tract infections (UTIs) or wounds, can prevent serious complications like osteomyelitis and sepsis which can result in hospitalization, death, and expensive medical care. The investigators have developed an innovative mobile health (mHealth) system aimed at improving self-management skills and preventing and detecting early signs of secondary medical complications. The system consist of a mobile health applications (apps), a clinician portal and a two-way secure communication system between the two. People with complex care regimens can use the apps to get reminders or cues to carry out their self care routines such as bowel/bladder routines, take medications, report success with their activities or new problems (e.g. new wound, UTI symptoms etc.), and track symptoms of depression. A clinician can use the portal to view the report and communicate with the users through a secure communication system that is embedded in the apps.

This study will assess the benefits of using the system in improving users' wellness and self-management skills compared to those who receive standard of care only.

Eligibility Criteria:
Inclusion Criteria:

1. 12 years or older.
2. have a diagnosis of a chronic and complex condition such as Spina Bifida, Spinal Cord Injury, Cerebral Palsy and Traumatic Brain Injury, etc.
3. live in a community setting (not within a residential facility that provides care to them).
4. pass all the functional screening tests which include basic usage of a smart phone, and impairment severity assessments

Exclusion Criteria:

1. Diagnosis of severe intellectual disability or severe and persistent psychiatric illness.
2. Failing all the screening tests due to severe impairments that cannot be accommodated by the mHealth system (for patient participants)
Double-Blind Study of Topical WBI-1001 Cream on Patients With Psoriasis

The purpose of this study is to evaluate primarily the safety and tolerability and secondarily the efficacy of topically applied WBI-1001 cream in patients with mild to moderate psoriasis. Double-blind, randomized, placebo controlled study of 36 patients, treated for 28 days plus a 7 day follow-up.in which the patients were divided into six cohorts: Cohort 1 at 0.5% QD;Cohort 2 at 0.5% BID; Cohort 3 at 1.0% QD; Cohort 4 at 1.0% BID; Cohort 5 at 2.0% QD; Cohort 6 at 2.0% BID.Efficacy assessed by PGA,target lesion assessment and BSA. Safety assessed through vital signs, ECG, AEs and Plasma PK via Cmin, Cmax,Tmax and AUCo-t.

Patients initiated screening within 4 weeks of commencing study treatment. Based on progression of the study, at day 0 patients were assigned to one of six treatment Cohorts. Patients were randomized to treat all areas except the face, scalp, groin and genital areas. Patients in Cohort 1 were treated on one side with a thin layer of active cream and the other with placebo; in the absence of significant AEs by 14 days after the last treatment in the Cohort escalation to the next Cohort was allowed, and each Cohort respectively.

During the treatment period patients visited the study centre weekly for safety, tolerability and efficacy assessment. On these study visit days blood draws were done between 7.00 and 10.00am prior to that morning's application of cream.

The study enrolled healthy male and female patients aged 18-65 y.o. with clinical diagnosis of stable plaque psoriasis for \>months affecting a maximum of 6% of BSA with a minimum of 0.5% BSA on each side of the body and a minimum of one plaque at least 2x2 cm on each side excluding elbow and knee.

Eligibility Criteria:
Inclusion Criteria:

* PGA score at day 0 must be 2,3 or 4.
* In good overall health.
* Women of child bearing potential to have negative serum beta-human chorionic gonadotropin pregnancy test before randomization
* Must be prepared to use adequate means of contraception
* Must not be lactating.
* Male partners of females in the study must be prepared to use adequate means of contraception.
* Must comply with study protocol and attend all visits.
* Provide written consent prior to participating in the study.

Exclusion Criteria:

* Spontaneously improving or rapidly deteriorating psoriasis.
* Patients with other diseases (especially dermatological, immunodeficiency or neurological/psychiatric) that might interfere with assessment of plaque psoriasis.
* Systemic immunomodulatory therapy in past 36 weeks, phototherapy in past 4 weeks, various psoriatic chemotherapies and beta blockers in the past 2 weeks
The Immediate Effects of Applying Dynamic Tape, Kinesio Tape and Sport Tape With Chronic Ankle Instability

Injuries to the ankle joint account for 20% of the population that is afﬂicted with joint injury and the largest percentage of self-reported musculoskeletal injuries (\> 10%) are to the ankle. Ankle sprain has a large portion in ankle injuries and occurs not only in the sporting population but also in the general community. Although the acute symptom would be resolve quickly, but many people still report persisting problems, such as pain and instability. Chronic ankle instability (CAI) is one of the most common of these residual problems.

Kinesio Tape and White Duck Tape are often applied in patients with CAI, attempt to increase the ankle joint stability, and improve motor performance. However, the previous studies had controversial result to the effects of kinesio tape and white duck tape. The previous studies also showed the insufficient of supporting force and elasticity of kinesio tape and white duct tape. The Dynamic Tape was developed by Kendrick in 2009, which refined the characteristic of elasticity and supporting force.

Therefore the purpose of study is to comparison the effects of static and dynamic balance performance, weight shifting ability and functional movement between kinesio tape, white duck tape and dynamic tape when applied on patients with CAI. With the result may provide an optical method to increase the movement performance of patients with CAI.

The study suspected to recruit 90 volunteers with CAI, and randomly divided to three different groups: Kinesio tape group, White duck tape group and Dynamic tape group. We make postural stability test and limit postural stability test with Biodex Balance System (SD), Y-balance test and single leg hop test to both affected side and sound side foot before applying the tape. After applying the tape according to the divided group, we will repeat the test above again. We will compare the results of the test between groups and within groups.


Eligibility Criteria:
Inclusion Criteria:

1. A history of at least one signiﬁcant ankle sprain

   * The initial sprain must have occurred at least 12 months prior to the study enrolment
   * Was associated with inﬂammatory symptoms (pain, swelling, etc)
   * Created at least one interrupted day of desired physical activity
2. A history of the previously injured ankle joint 'giving way' , and /or recurrent sprain and/or 'feelings of instability'.

Exclusion Criteria:

1. A history of previous surgeries to the musculoskeletal structures (ie, bones, joint structures and nerves) in either lower extremity.
2. A history of a fracture in either lower extremity requiring realignment.
3. Acute injury to the musculoskeletal structures of other joints of the lower extremity in the previous 1 months, which impacted joint integrity and function (ie, sprains, fractures) resulting in at least 1 interrupted day of desired physical activity.
A Study Comparing Implant Provision by Community Health Extension Workers With Nurses and Midwives in Nigeria

This proposed study, to be run by Marie Stopes International Organisation Nigeria (MSION) will investigate whether Community Health Extension Workers (CHEWs) in Nigeria can insert and remove contraceptive implants to the same level of safety and quality as a nurse or midwife, and whether this is acceptable to their clients and colleagues. The study will also document feasibility issues which would be relevant to any future national programmatic scale-up.


Eligibility Criteria:
Inclusion Criteria:

* facilities are located with 20km of a referral facility
* facilities - facility staff are willing to participate, e.g. willingness to conduct family planning awareness-raising activities, willing to maintain project records
* facilities - selected provider at each facility expects to be in the facility for the 12-month period of client recruitment
* clients - women present to attending facilities and request a contraceptive implant

Exclusion Criteria:

* facilities - involved in overlapping interventions
Neoadjuvant Chemotherapy Followed by Chemoradiation Versus Chemoradiation for Stage IIIC Cervical Cancer Patients: A Randomized Phase III Trial

Evaluate the efficacy and safety of neoadjuvant chemotherapy (NAC) with albumin-bound paclitaxel and carboplatin followed by chemoradiation therapy (CRT) for stage IIIC cervical cancer patients with carcinoma \>4 cm in greatest dimension and/or lymph node \>2cm in short axis.

in this phase III tiral , stage IIIC cervical cancer patients with carcinoma \>4 cm in greatest dimension and/or lymph node \>2cm in short axis will be randomly assigned to two circles of NAC with albumin-bound paclitaxel and carboplatin followed by standard CRT with weekly cisplatin plus pelvic radiotherapy or to standard CRT alone.

The primary end point was 3-year progression-free survival (PFS). Secondary end points were response rate, 3-year locoregional control, 3-year overall survival (OS), safety, and quality of life.

Eligibility Criteria:
Inclusion Criteria:

1. pathologically comfirmed : squamous cell, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix；
2. FIGO (2018 International Federation of Gynecology and Obstetrics) stage IIIC with carcinoma \>4 cm in greatest dimension and/or lymph node \>2 cm in short axis at initial diagnosis.
3. age 18 to 70 years；
4. Eastern Cooperative Oncology Group performance status 0 to 2；
5. adequate organ function.

Exclusion Criteria:

1. not at initial diagnosis; 2. with other kind of tumor.

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Effects of Holy-Comod and Tears Naturale Forte in Patients After Phaco+IOL

The purpose of the study it to compare the effects of Holy-Comod and Tears Naturale Forte on ocular surface and tear inflammatory mediators in patients after Phaco+IOL.


Eligibility Criteria:
Inclusion Criteria:

* 60-72 years old
* classification of lens nucleus is LOCS Ⅱ

Exclusion Criteria:

* patients with previous history of ocular surgery, corneal diseases,uveitis ,ocular hypertension or glaucoma ,systemic diseases.
Study Evaluating the Safety and Ability to Produce Immune Response of Prevenar and Meningitec Given at the Same Time

The purpose of this study is to evaluate the safety and immunogenicity of concomitant Prevenar and Meningitec compared to Prevenar alone and Meningitec alone when used as part of the routine vaccination series in healthy infants


Eligibility Criteria:
Inclusion Criteria:

* Healthy infants aged 6 to 9 weeks
Modulation of SERCA2a of Intra-myocytic Calcium Trafficking in Heart Failure With Preserved Ejection Fraction

The goal of this clinical trial is to test an experimental gene therapy in participants with heart failure with preserved ejection fraction, also known as diastolic heart failure. The main questions it aims to answer are:

* safety and tolerability of the gene therapy; and
* whether the gene therapy helps the heart ventricles relax during filling. Participants will undergo a one-time infusion of the gene therapy in the cardiac catheterization laboratory and then be followed for safety and effects on left-sided filling pressures while exercising. The first year will have multiple in-person visits followed by 4 years of biannual phone calls.

Eligible participants will undergo a one-time antegrade epicardial coronary artery infusion of gene therapy delivered to the 3 major cardiac territories of the left ventricle of the heart (anterior, lateral, inferior/posterior) or bypass grafts unless contraindicated. Post-procedure, the subject will be monitored continuously for a minimum of 4 hours and then discharged to home that same day if medically appropriate. Participants will be followed for 52 weeks as part of the main trial. On Day 2 and Week 1, subjects will be contacted by phone for a general safety assessment, and if clinically indicated, an in-person evaluation and assessment will be performed as soon as possible. On Weeks 2, 4, 12, 24 and 52, subjects will undergo general safety assessments. Additionally, at Weeks 24 and 52, subjects will undergo outpatient core resting and exercise transthoracic echocardiography, right heart catheterization with hemodynamic monitoring and gas exchange measurements, 6-minute wall test, cardiac biomarker testing and completion the Kansas City Cardiomyopathy Questionnaire. Upon completion of the active observation period, participants will continue to be followed for 4 years with bi-annual, semi-structured telephone or in-person questionnaires that collect information on overall status and other comorbid conditions of interest in gene therapy trials.

Eligibility Criteria:
Inclusion Criteria:

* Willing and able to provide informed consent
* Negative for anti-AAV1 neutralizing antibodies
* NYHA class II or III
* Left ventricular ejection fraction ≥ 50%
* Evidence of resting or exercise-induced left ventricle filling pressure
* On oral diuretic therapy
* Adequate birth control

Exclusion Criteria:

* NYHA class IV
* Heart failure requiring hospitalization in the past 3 months
* Manifested or provocable ischemic heart disease
* Atrial fibrillation
* History of congenital heart disease, restrictive or infiltrative cardiomyopathy, hypertrophic cardiomyopathy, acute myocarditis, pericardial disease, uncorrected thyroid disease or discrete left ventricular (LV) aneurysm
* History of amyloidosis
* Untreated left-sided valvular disease
* Severe COPD
* BMI \> 50 kg/m\^2
* Severe liver, kidney or hematologic dysfunction
* Cancer within the past 5 years
* Unstable concurrent conditions