cyrilzakka/clinical-trials huggingface dataset:
Transdermal Lidocaine for Pain Control During Diagnostic Office Hysteroscopy

To compare the effectiveness of Transdermal Lidocaine for Pain Control During Diagnostic Office Hysteroscopy

hysteroscopy is commonly used in the diagnosis and treatment of intrauterine lesions such as polyps, ﬁbroids, septa, and adhesions, and in the presence of abnormal bleeding and during the removal of an intrauterine device or foreign body. Cervical ripening is made possible by the use of medication through different routes.

Eligibility Criteria:
Inclusion Criteria:

* patients with an indication for ofﬁce hysteroscopy

Exclusion Criteria:

* patient refuse to participant
* contraindication for lidocaine patch
Evaluation of the Diagnostic Performance of a Bra Prototype to Detect Breast Cancer

Phi-Bra is a prospective and monocentric pilot study to assess the diagnostic capability of an innovative bra prototype to detect breast cancer, compared to the current standard of care: the mammography.

The Phi-Bra prototype is designed with sensors measuring different parameters simultaneously such as impedance and temperature.

The bra will be tested on patients without breast lump (American College of Radiology (ACR) 1 et 2 Birads classification) and with breast lump (ACR 4b, c ou ACR 5 Birads classification).

The aim of this pilot study is to compare the results obtained by Phi-Bra to the ones obtained by mammography.

The Phi-Bra study is classified as clinical investigation category 4.4 based on the European Union (EU) regulation (DM 2017/745).


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 75.
* No breast cancer surgery background
* Bra size : S/M or M/L

Specific criteria for the "no breast lump" cohort:

- Negative mammography result (ACR 1 a 2).

Specific criteria for the "breast lump" cohort:

- Suspicious breast lump discovered during the mammography (ACR 4b ou c ou ACR 5) and for which there is an indication of microbiopsy.

Exclusion Criteria:

* Breast cancer background (surgery or radiotherapy)
* Breast lump classified as ACR 3 ou ACR 4a during the mammography
Evaluation of ACCS100 to Reduce Aflatoxin Exposure in Kenya

The purpose of this study is to pilot test the effectiveness, acceptability, and palatability of ACCS100 in a high-risk Kenyan population.

Aflatoxins are harmful by-products of the molds Aspergillus flavus and A. parasiticus and are major contaminants of agricultural produce such as maize. Acute aflatoxin exposure (i.e., aflatoxicosis) can lead to jaundice, vomiting, abdominal pain, and liver failure, with documented fatality rates as high as 40%. Kenya experiences extreme aflatoxin exposure and fatal, recurring aflatoxicosis outbreaks. Numerous clinical trials have found heat processed calcium dioctahedral smectite clay \[i.e., Air Classified Calcium Silicate (ACCS100)\] to be safe and effective in binding to aflatoxin to decrease bioavailability and subsequently reduce toxin-induced effects. The investigators propose to pilot test the effectiveness, acceptability, and palatability of ACCS100 in a high-risk Kenyan population. If successful, ACCS100 could be scaled-up for use in Kenya to prevent aflatoxin-associated mortality during high-risk periods. To accomplish this objective, the investigators will recruit fifty health adults into a crossover study. Each participant will spend one week consuming ACCS100 and one week consuming a calcium carbonate placebo. Daily first morning void urine samples will monitor effectiveness in reducing aflatoxin bioavailability, and periodic questionnaires will assess acceptance and palatability.

Eligibility Criteria:
Inclusion Criteria:

* Adult ≥18 years of age
* Consumes corn- and/or peanut-derived foods at least four times per week
* No plans to travel away from the household for more than one day in the next month

Exclusion Criteria:

* Women who may be pregnant
* History of medical illnesses
* Presence of protein or glucose in urine using chemstrip
* Does not provide informed consent
The Effectiveness of Adopting Humanized Service Program on Transabdominal Ultrasound About Pregnant Women's Service Quality and Satisfaction

The Effectiveness of Adopting Humanized Service Program on Transabdominal Ultrasound About Pregnant Women's Service Quality and Satisfaction


Eligibility Criteria:
Inclusion Criteria:

1. Adult over the age of 20 pregnant women.
2. Clear consciousness, those without severe cognitive impairment, such as dementia, mental retardation or mental illness.
3. Literacy and the use of Chinese or Taiwanese.
4. Willingness to participate in the research.

Exclusion Criteria:

Refused to participate in the research
Efficacy and Safety of Milnacipran in the Treatment of Fibromyalgia in an Elderly Population

Participants will undertake a 12-week, open-label study of milnacipran in a well-characterized cohort of patients with fibromyalgia syndrome (FMS) who are 65 years and older to investigate the short-term efficacy and safety of this drug in the elderly population. The investigators hypothesize that milnacipran will be effective in treating fibromyalgia syndrome (FMS), and will be prove to be safe when patients are selected for the absence of pre-existing blood pressure abnormalities and other serious medical conditions.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients.
* Age 65 years or older.
* Fibromyalgia diagnosed according to ACR 1990 criteria.
* Pain Score ≥ 10 on Gracely scale at screening and baseline assessments.
* Discontinuation of other dual-acting antidepressant medications, including duloxetine, venlafaxine, and tricyclic antidepressants for a period not less than 4.5 times the drug half-life as of the baseline evaluation.

Exclusion Criteria:

* Uncontrolled hypertension (BP ≥ 140/90) at screening or baseline evaluations.
* Baseline orthostasis (documented drop in SBP ≥ 20 mmHg or in DBP ≥ 10 mmHg within 3 minutes after standing) at screening or baseline evaluations.
* Psychosis, active suicidality, current episode of major depression or other severe psychiatric illness, or current alcohol/substance abuse or dependence as assessed by the MINI.
* Significant cardiovascular disease, including atrial fibrillation or other dysrhythmia, congestive heart failure, valvular heart disease, or QTc prolongation on baseline EKG (\> 450 msec).
* Uncontrolled narrow angle glaucoma.
* History of seizures.
* Use of MAO inhibitor drugs within the last 14 days.
* Abnormal baseline liver or renal function tests.
* Dementia or other syndrome of cognitive impairment that could interfere with the subject's ability to participate fully in the assessment protocol.
* Obstructive uropathy in males.
Biventricular Tachycardias Outcome Trial

This clinical investigation is a device-based open, prospective, multicenter two-arm randomized trial, comparing patients who are treated in the slow VT zone versus patients who are not treated in that zone.

The device intended to be used is the OVATIOTM CRT model 6750 but future generation of Sorin Group/ ELA Medical devices may be used provided they are CE marked. Ethics committees and health authorities will be informed prior to any use of a newer device if applicable.

All patients will have a 3-zone detection configuration programmed. The slow VT zone will be defined by programming the detection parameters as follows:

* Slow VT detection rate: 100 bpm (or if the resting rate is higher than 80 bpm, we recommend to adjust this parameter to: resting rate + 30 bpm)
* VT detection rate: 150 bpm

PARAD+ will be the first choice for SVT/ST and VT discrimination in the VT zones.

The Fast VT and VF limits are left to investigator's judgment. Therapy on VT, fast VT and VF are also left to the investigator's judgment.

Patients will be randomized at implant to have the slow VT zone programmed as a monitoring zone (monitoring arm) or to have therapies programmed within the slow VT zone (therapy arm). The randomization table will be generated by Sorin Group/ELA Medical.


Eligibility Criteria:
Inclusion Criteria:

* Patient has been prescribed the implantation or replacement of a CRT-ICD system accordingly to the relevant currently-approved ACC/AHA15 (August 2005, Appendix §M.10) or ESC 16 (Update 2005, Appendix § M.11) guidelines or any relevant currently-approved local guidelines for the implantation or replacement of CRT-ICD.
* Patient has signed a consent form after he/she received the appropriate and mandatory information.

Exclusion Criteria:

* Clinical history of symptomatic or not symptomatic slow VT;
* Permanent Atrial Fibrillation (AF);
* Any contraindication to the implant or replacement of CRT-ICD;
* Pt is unable to attend the scheduled f-up visits at the implanting Centre;
* Pt is already included in another ongoing clinical study;
* Pt is unable to understand the objectives of the ITAC04 study;
* Pt refuses to cooperate;
* Pt is unable or refuses to provide informed consent;
* Pt is minor (less than 18-year old);
* Pt has life expectancy of less than 1 year;
* Pt is pregnant.
Case Management Study for Postpartum Depression and Intimate Partner Violence

The objective of the study was to assess the prevalence, timing, and co-occurrence of positive screens for maternal postpartum depression (PPD) and intimate partner violence (IPV) for women bringing their young infants for pediatric primary care and examine relationships between PPD, IPV and children's healthcare utilization from birth to 2 years.

Post-partum depression (PPD) and intimate partner violence (IPV) negatively affect the health and well-being of millions of women each year. In turn, PPD and IPV frequently compromise women's ability to form a strong mother-infant bond, which potentially impacts their children's health and well-being. Limited information exists regarding the prevalence of PPD, IPV, and the co-occurrence of the two. Similarly, empirically tested interventions designed to improve outcomes for these women and their infants are lacking.

The objective of the research was to assess the prevalence, timing, and co-occurrence of positive screens for maternal postpartum depression and intimate partner violence and examine their relationships with children's healthcare utilization from birth to 2 years.

As per routine protocol in the Harriet Lane Clinic (HLC), all mothers bringing their infants for a well baby visit (birth to 6 month visit) are screened for PPD and IPV using a brief, self-administered paper-based questionnaire at the start of the visit. Appropriate resource and referral materials will be provided by a Family Support Counselor (FSC) in the clinic. Between February and March 2008, mothers bringing newborn, 2-, 4-, or 6-month-old children to an urban primary care clinic were screened for postpartum depression and intimate partner violence. A retrospective chart review abstracted demographic data, maternal responses on the postpartum depression/intimate partner violence screen at the initial and subsequent visits, and, from the child's birth to second birthday, adherence with well-child care and use of pediatric acute care and emergency department visits. Descriptive, bivariate, and multivariate analyses were conducted.

Eligibility Criteria:
Inclusion Criteria:

* English-speaking mothers of infants presenting for their newborn, two, four or six month visits to their primary care provider in the Harriet Lane Clinic

Exclusion Criteria:

* none
Study Evaluating Premarin and Bazedoxifene Potential Interaction

The purpose of this study is to evaluate the pharmacokinetics (absorption, distribution, breakdown and elimination in the body) of a single dose of bazedoxifene (BZA) 20 mg tablet when administered together with multiple doses of Premarin (conjugated estrogens or CE) to healthy postmenopausal women.

Information will also be obtained regarding the safety and tolerability of this combination in healthy, postmenopausal women.


Eligibility Criteria:
Inclusion Criteria:

* For inclusion into the study, women must be healthy and postmenopausal (either naturally or surgically) between the ages of 35 and 70, inclusive.
* Blood hormone levels must be consistent with a postmenopausal state (for specified subjects).
* They can either be a non-smoker or smoke less than 10 cigarettes per day, and be able to abstain from smoking during clinic confinements

Exclusion Criteria:

* A subject will be excluded from participation if they :
* Have participated in a clinical drug study within 30 days prior to study medication administration;
* Have a history of drug or alcohol abuse within 1 year or consume more than 2 standard units per day of alcohol (a standard unit equals 12 ounces of beer, 1 ½ ounces of 80-proof alcohol or 6 ounces of wine);
* Donate any other plasma or blood during the total study.
Autologous Muscle Stem Cell Therapy for Treatment of Congenital Urinary Incontinence in Epispadias Patients

The aim of this trial is to evaluate the safety and efficacy of an autologous muscle stem cell therapy in the treatment of congenital urinary incontinence in isolated epispadias.

Epispadias is the mildest form of exstrophy-epispadias complex (EEC); a congenital malformation disorder involving the midline abdominal and genitourinary structures. Patients with epispadias have a defect in the urethral sphincter resulting in urinary incontinence. This trial investigates the injection of autologous primary human muscle stem cells into the urethral sphincter with the aim of repairing the defect and restore the anatomic ability for continence.

Eligible participants will undergo muscle biopsy during a routine cystoscopy. Acquired muscle tissue is used for the isolation and expansion of muscle stem cells ex-vivo. Muscle stem cells are injected into the urethral sphincter under visual control using cystoscopy. Participants are assessed for safety and efficacy for a minimum of 12 months post-intervention.

Eligibility Criteria:
Inclusion Criteria:

* Male
* Isolated epispadias
* Aged ≥ 3 years
* Urinary incontinence as defined according to the International Children´s Continence Society
* Informed consent

Exclusion Criteria:

* Acute or chronic inflammatory local or systemic disease
* Coagulation Disorder
* Previous adverse reaction to anesthesia
* Congenital heart defect, cardiac arrhythmia
Tackling Intrusive Traumatic Memories After a Difficult Birth

This proof-of-principle study aims to investigate the effects of a brief behavioural procedure including a computerized visuospatial task (the computer game "Tetris") preceded by a reactivation of the traumatic memory of childbirth, on birth-related intrusive traumatic memories and other postpartum posttraumatic stress symptoms. Women who report birth-related intrusive memories after 6 weeks postpartum will monitor their intrusive traumatic memories in a daily diary. After two weeks of diary, they will meet a psychologist to briefly evoke the memory of their birth, and receive a brief behavioural procedure including playing Tetris. Participants will then continue to complete an intrusive traumatic memory diary during two weeks. It is predicted that they will report fewer intrusive memories in the two weeks following the intervention, compared to the two weeks before. This will inform the potential future development of a simple computerized intervention procedure to reduce distressing psychological symptoms after traumatic childbirth.


Eligibility Criteria:
Inclusion Criteria:

* Gave birth at the Lausanne University Hospital
* Gave written consent
* Have at least 4 related-to-childbirth intrusions over the two weeks prior to recruitment, and at least 2 related-to-childbirth intrusions during the pre-intervention diary
* Gave birth more than 6 weeks ago
* Is able to distinguish intrusions linked to the traumatic childbirth from intrusions linked to other traumatic events

Exclusion Criteria:

* Gave birth to a stillborn child
* Not fluent in French
* Severe illness of mother or infant (e.g. cancer, cardiovascular disease, severe neurodevelopmental difficulties, malformations)
* Have an established intellectual disability, or psychiatric history such as psychotic illness
* Alcohol abuse and/or illegal drug use
* Currently receiving psychological care in relation with the traumatic birth experience
A Dose-finding Study of JMKX003142 in Treatment of Cardiac Edema

To Evaluate the Safety, Efficacy, and Pharmacokinetic/Pharmacodynamics Characteristics of JMKX003142 injection Administered Randomly,Double-blind, Placebo-controlled Study in Chinese Cardiacl Edema Patients.


Eligibility Criteria:
Inclusion Criteria:

1. Can fully understand the purpose and process of the study and voluntarily sign the informed consent form;
2. Age ≥ 18 years old when signing the informed consent form;
3. At the screening stage, it has been definitely diagnosed as heart failure, and it is combined with one of the following clinical manifestations related to body fluid retention: edema of both lower limbs, jugular vein engorgement, pulmonary congestion;
4. The screening phase is currently undergoing or preparing to use one of the following diuretic therapy as background treatment during the run-in period:

1) At least 40mg/day of furosemide equivalent loop diuretics; 2) Any dose of loop diuretics combined with thiazide diuretics; 3) Any dose of loop diuretics combined with aldosterone receptor antagonists or other potassium sparing diuretics.

5. After the background treatment in the run-in period, the subject still has the following two conditions:

1. One of the following clinical manifestations related to fluid retention still exists after the induction phase treatment: edema of both lower limbs, jugular vein dilatation, pulmonary congestion;
2. During the import phase, the weight of D-1 does not change by more than 1.0 kg compared to D-3.

Exclusion Criteria:

1. Edema caused by diseases other than heart failure；
2. Subjects with ventricular assist devices during screening;
3. Subjects diagnosed with active myocarditis, myocardial amyloidosis, hypertrophic cardiomyopathy (excluding dilated phase), or valve disease with obvious valve stenosis during screening;
4. Acute myocardial infarction occurred within 30 days prior to screening; subjects with a history of persistent ventricular tachycardia or ventricular fibrillation within the 30 days prior to screening (those without implantable defibrillators); History of cerebrovascular disease within 6 months prior to screening (excluding asymptomatic cerebral infarction);
5. Subjects with hypovolemia or suspected hypovolemia;
6. Subject cannot feel thirst or have difficulty in fluid intake during screening;
7. During screening, the systolic blood pressure is less than 90mmHg or the diastolic blood pressure is less than 60mmHg;
8. Administered with tolvaptan 14days before randomization ；
9. Pregnancy (female pregnancy test positive) or lactation period;
Covid-19 Risk Factors and Pattern Between Healthcare Workers

Assessment of the Pattern and Risk Factors of Covid-19 between infected Healthcare Workers at Assiut University Hospitals

COVID-19 is a respiratory infectious disease caused by a novel coronavirus, SARS-CoV-2. The first batch of COVID-19 patients were found in December 2019 (1). The disease is mainly transmitted through respiratory droplets and close contact, and all people are susceptible to it (2). SARS-CoV-2 is highly contagious (3), and has quickly spread to most countries and regions of the world. COVID-19 has become a global pandemic and has received great attention from all over the world (4, 5). Till April 7, 2020, 1,214,466 confirmed cases of COVID-19 have been found in 211 countries and regions, causing 67,767 deaths (6). The main clinical manifestations of COVID-19 are cough, fever, malaise, chest distress and tachypnia and complications such acute respiratory distress syndrome.

Healthcare workers (HCWs) are on front line of treating patients infected with COVID-19. However, data related to infection rate among HCWs are limited. Early available evidence suggested that HCWs are being increasingly infected with the novel infection ranging from 15% to 18% and in some cases up to 20% of the infected population. Major risk factors of infection among HCWs include lack of understanding of the disease, inadequate use and availability personal Protective Equipment (PPE), uncertain diagnostic criteria, unavailability of diagnostic tests and psychological stress. Therefore the protection of HCWs by authorities should be prioritized through education and training, the readiness of staff, incentives, availability of PPEs, and psychological support. In this time of COVID-19 pandemic, big problem in hospitals that are flooded with infected symptomatic and asymptomatic patients. A critical aspect is the protection of the HCWs who are at risk, including individuals more than 50 years old those with presence of a systemic disease, smokers and disabled individuals. These HCWs should be identified and not assigned duties inwards and premises managing COVID 19 patients

Eligibility Criteria:
Inclusion Criteria:

- Health care workers in Assiut University Hospitals ( ≥ 18 years old) who were infected with covid-19 and were diagnosed based on either PCR testing or based on radiological diagnosis.

Those who were not in contact with household Covid-19 patients within 14 days before getting infected.

Those who were adherent to social isolation apart from their work

b. Exclusion criteria : Patients with Covid-19 who are not HCWs in Assiut University Hospital. Those who were in contact with household infected patients within 14 days before getting infected.
PlayGait: A Dynamic Exoskeleton

PlayGait is an investigational dynamic energy storage and return (ESR) lower-limb exoskeleton for young children with cerebral palsy (CP), that stores energy while the child is in the stance phase of walking and returns that energy in terminal stance and early swing phase of walking. PlayGait assists with the passive dynamics of walking through an exotendon (comprised of a spring in series with a cable). The overall objective of this investigational device is to promote correct walking patterns that encourage proper bone alignment, muscle recruitment, and strengthening during walking practice in young children with CP. The study will evaluate children with CP's activity levels in the community with and without PlayGait. The study will consist of three lab visits and two, 7-day periods at home.


Eligibility Criteria:
Inclusion Criteria:

* Age 3 - 4 years (at time of informed consent)
* Hemiplegic cerebral palsy
* If child uses an ankle-foot orthosis (AFO), parent/caregiver is willing to have the child stop wearing their prescribed AFO during data collections (lab sessions and two 7-day periods at home)
* Ability to walk at least 10 meters without the use of assistive devices or AFOs
* Ability to walk at least 1 minute without the use of assistive devices or AFOs
* Stiff knee gait - less than normal knee flexion during swing phase
* Hip flexion passive range of motion contracture less than 20 degrees
* Gross Motor Function Classification System (GMFCS) Levels I-II
* Modified Ashworth Scale (MAS) \<=2 for the gastrocnemius soleus, rectus femoris, and hamstrings
* Family has resources to attend all study sessions (transportation, schedule)
* Ability to speak and understand in English

Exclusion Criteria:

* Orthopedic surgery in the last year
* Foster children or wards of the state
* Use wheelchair or stroller mobility as their primary method of independent mobility
* Severe visual impairment such that the visual impairment itself functionally limits mobility
* Phenol or Botox injections to the legs in the last 3 months
* Uncontrolled seizure disorder, defined as any seizure in the last 3 months that influenced mobility skills and function (seizures which did not affect mobility are acceptable)
* Lower limb fracture in the last 3 months
* Planned surgery or changes to movement disorder medication during the study period
* Inability to understand directions sufficiently to complete the study assessments
* Cognitive, behavioral, or any other issues that may not allow for effective study participation
* Unwilling to complete the study protocol