cyrilzakka/clinical-trials huggingface dataset:
Clinical Study for the Treatment With Interferon-ß-1a (IFNß-1a) of COVID-19 Patients

Pharmacological therapies of proven efficacy in coronavirus disease 2019 (COVID-19) are still lacking.

Since two clinical stages of COVID-19 are emerging, an early one with typical clinical characteristics of a viral infection (fever, malaise, cough) and a later one with pneumonia leading to progressive respiratory failure, associated with heavy, cytokine-mediated, inflammation, an intervention by a compound possessing both antiviral activity and immunomodulatory effects would be most effective at the earliest possible stage.

The purpose of this clinical trial is to test the efficacy of Interferon-β-1a (IFNβ-1a), in COVID-19 patients in an open label, randomized clinical trial.

The design of the study is to test IFNβ-1a in addition to standard of care compared with standard of care alone.

The primary outcome is the time to negative conversion of Severe Acute Respiratory Syndrome-CoronaVirus-2 (SARS-CoV-2) nasopharyngeal swabs.


Eligibility Criteria:
Inclusion Criteria:

1. Informed consent signed
2. Patients hospitalized with confirmed swab RT-PCR detection of SARS-CoV-2
3. X-ray and/or CT diagnosed pneumonia
4. Age \>=18 years
5. Clinical status defined as 3, 4 or 5 on the 7-point ordinal scale

Exclusion Criteria:

1. Known allergy or hypersensitivity to IFNß-1a or IFNß-1b
2. Presence of severe concomitant illnesses/medical conditions that in the physician opinion do not allow participation to the study
3. Pregnant or lactating females
4. History of major depression disorder or suicidal attempt or suicidal ideation
5. Spontaneous blood alanine aminotransferase/aspartate aminotransferase (ALT/AST) levels \> 5 times the upper limit of normal
6. Clinical status defined as 1, 2, or 6 on the 7-point ordinal scale
MaCRA Part B in Côte d'Ivoire

This study aims to evaluate the effectiveness of monthly malaria rapid diagnostic test (RDT) validation meetings at district level on reducing the proportion of RDT results recorded as positive in health facility registers in Cote d'Ivoire.

PMI Insights supported a multi-country evaluation of the accuracy of the recording and reporting of rapid diagnostic test (RDT) results at health facilities in Benin, Côte d'Ivoire, Nigeria, and Uganda (MaCRA Part A). The evaluation found a high degree of agreement between RDT results recorded in health facilities and an objective panel reading of the same RDTs. However, the changes in test positivity rate (TPR) after the start of the study suggest that some of this agreement may have been a result of the Hawthorne effect: in all countries except Benin, TPR declined after the start of the evaluation in facilities where evaluation staff were present, compared with control facilities. This suggests that the presence of evaluation staff caused health care workers to change their behavior with respect to reporting positive RDT results. The study evaluated the durability of RDT results and found that 95% of RDT cassettes retained their original reading over a one-month period. This provides evidence that stored RDT cassettes may be compared to health facility registers at monthly validation meetings, as long as a certain margin of error is used to account for the proportion of tests that may change.

The results from the first phase of the study were used to identify potential interventions to improve RDT reporting and recording accuracy in health facilities. The second phase of the study aims to evaluate the effectiveness of monthly district-level RDT result validation meetings on reducing the proportion of RDT results recorded as positive in health facility registers and reported to the national health management information system.

This is a two-arm cluster-randomized controlled effectiveness evaluation. Districts will serve as the clusters and will be assigned using restricted randomization to the intervention or control arm. In the intervention arm, the Ministry of Health will lead monthly district-level RDT validation meetings facilitated by a digital phone-based app which uses AI to record RDT results (HealthPulse, Audere, Johannesburg, South Africa). There will be no study activities in the control facilities.

Monthly RDT validation meetings will take place over a four-month period (April to July 2025), after which a cross-sectional survey and in- depth interviews will be conducted.

Eligibility Criteria:
Inclusion Criteria:

* Healthcare workers responsible for testing or interpreting malaria RDTs in the selected study facilities
* District and regional health teams involved in the monthly RDT validation meetings from districts selected for the study.
A Research Study to Compare Two Forms of Semaglutide in Two Different Pen-injectors in People With Overweight or Obesity

The study will look at how two different forms of semaglutide reach and stay in the blood after injection. None of the two forms of semaglutide have been approved by the authorities to treat obesity. Participants will get 1 of the 2 forms of semaglutide - which one is decided by chance. Participants will get the medicine as an injection under the skin of the stomach with the use of a pen-injector. The type of pen-injector is different for the two forms of semaglutide. The study staff will teach participants how to inject themselves with the medicine. As part of this training participants will self inject placebo (dummy medication) 3 times. Participants will take an injection once a week and will get 21 injections in total of study medication. The study will last for about 27-30 weeks. Participants will have 25 study visits with the study doctor. For 2 of the visits, participants will stay in the clinic for 3 days and 2 nights. Participants may have to stop the study if the study doctor thinks that there are risks for their health. Women cannot take part if they are pregnant, breast-feeding or planning to become pregnant during the study period.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 18-65 years (both inclusive) at the time of signing informed consent
* Body mass index (BMI) between 27.0 and 34.9 kg/m\^2 (both inclusive)
* Body weight between 70.0 and 130.0 kg (both inclusive)

Exclusion Criteria:

* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method
* Any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol
* Inability or unwillingness to perform self-injection
Transforming Hypertension Treatment in Nigeria Using a Type II Hybrid, Interrupted Time Series Design

The purpose of the Transforming Hypertension Treatment in Nigeria Program is to improve awareness, treatment, and control of hypertension in Nigeria through the adaptation, implementation, and evaluation of the effectiveness and implementation of a system-level hypertension control program.

This study includes the implementation and evaluation of a culturally- and contextually-adapted intervention package based on the Kaiser Permanente Northern California and World Health Organization HEARTS programs for hypertension diagnosis and treatment at primary health centers in Abuja, Nigeria. The intervention has been adapted based on a local needs' assessment including evidence synthesis and specific exploration of health care workers' knowledge, attitudes, and behaviors related to hypertension, causes, consequences, and treatment, including fixed-dose combination and patient self-management, and patients' knowledge, attitudes, and behaviors related to hypertension, causes, consequences, and treatment. Implementation pathways have been developed with particular attention to overcoming modifiable system- and patient-level barriers to hypertension treatment and control across capability, intentional, and system domains using the Consolidated Framework for Implementation Research. Preparedness and capacity have been assessed at primary health centers (e.g. available staff; information systems; use of clinical guidelines) through an adapted Service Availability and Readiness Assessment (SARA) instrument during the formative work for this study. The multi-level implementation package includes: 1) patient registration and empanelment (health system level), 2) standard treatment protocol (national policy level), 3) encouragement of fixed-dose combination therapy (health system level), 4) team-based care (health worker level), and 5) home blood pressure monitoring and health coaching (patient-level).

Eligibility Criteria:
Inclusion Criteria:

* Adults (≥18 years).
* Elevated blood pressure (Systolic Blood Pressure ≥ 130 mmHg or Diastolic Blood Pressure ≥ 80 mmHg) documented or measured by a health care professional (e.g., physician, Community Health Extension Worker, or Community Health Officer).

Exclusion Criteria:

* Individuals who are not yet adults (minors)
* Prisoners or other detained individuals.
High Flow Nasal Cannula for Safe Apnea

This is a prospective randomized controlled trial comparing high flow nasal cannula and buccal oxygenation as method of oxygenation during apnea in children.

This is a prospective randomized controlled trial comparing two oxygenation methods for prolongation of apnea time in children aged 0 to 10 years old.

This study measures time for the pulse oximetry drop from 100% to 92% after oxygenation with 100% oxygen, applying high flow nasal cannula or buccal oxygen insufflation via an oral Ring-Adair-Elwyn endotracheal tube connected to oxygen.

Eligibility Criteria:
Inclusion Criteria:

* Children under 11 years old undergoing general anesthesia with American Society of Anesthesiologists Physical Status 1 or 2.

Exclusion Criteria:

* Refusal of enrollment from one or more legal guardians of the patient
* Plan of usage of supraglottic airway device as airway maintenance device
* Presence of upper respiratory tract infection of lung disease
* Premature infants younger than postconceptual age of 40 weeks
* Anticipation of difficult bag-mask ventilation due to facial anomaly or micrognathia
* Other conditions that are considered inappropriate for the study
The Role of Anti-Reflux Surgery for Gastroesophageal Reflux Disease in Premature Infants With Bronchopulmonary Dysplasia

The purpose of this study is to evaluate the efficacy of fundoplication in premature infants with GERD and BPD.

Gastroesophageal reflux disease (GERD) has been postulated to result in chronic aspiration contributing to the development of chronic lung disease, otherwise known as bronchopulmonary dysplasia (BPD) in premature infants. This association has been indirectly based on anecdotal improvement in the respiratory status of infants with BPD after anti-reflux therapy, but the direct causal relationship has been difficult to prove. In addition, the historical evidence for infants with GERD has been based on acid reflux only which is diagnosed by 24 hour intra-esophageal pH monitoring, the gold standard. However, with the introduction of multi-channel intraluminal impedance (MII), GERD can now include non-acid reflux. The contribution of non-acid reflux to the development of BPD in premature infants is unknown. As our understanding of GERD has improved, previous assumptions regarding the efficacy of therapy may no longer be valid. The utilization of anti-reflux surgery (fundoplication) for the treatment of BPD in premature infants with GERD has not been rigorously studied. The efficacy of fundoplication in this patient population has yet to be determined.

Eligibility Criteria:
Inclusion Criteria:

1. Must meet all inclusion criteria for Initial Evaluation of GERD
2. Positive pH-MII test for GERD
3. Upper GI contrast radiograph to evaluate for associated congenital gastrointestinal anomalies
4. \> or = 2 kg (due to technical limitations of fundoplication)

Exclusion Criteria:

1. Previous intra-abdominal surgery except for gastrostomy
2. Those deemed not surgical candidates
3. Infants with associated congenital gastrointestinal anomalies
4. \> or = 1 year of age at time of Initial Evaluation of GERD
Adjuvant Post-Tamoxifen Exemestane Trial

The ATENA phase III randomized parallel-group multicenter trial is designed to compare 5 years of adjuvant exemestane versus 5 years of observation in postmenopausal women with operable breast cancer who have received 5-7 years of adjuvant tamoxifen. The primary endpoint for the core protocol is disease-free survival (DFS). Exemestane treatment is planned for 5 years unless disease relapse or excessive toxicity is documented, the patient refuses further treatment or any new anti-cancer therapy is initiated.

* Patients must have completed at least 5 years and not more than 7 years of continued treatment with tamoxifen (20 mg/day), while tamoxifen could have been discontinued up to 6 months prior to study entry.
* A substudy (ATENA lipid substudy)is designed to evaluate changes in the patients' serum lipid profile during study treatment.

Eligibility Criteria:
Inclusion Criteria:

* postmenopausal women only
* histologically confirmed stage I-IIIA primary adenocarcinoma of the breast
* estrogen and/or progesterone receptors positive or unknown
* patients should have undergone surgery with a curative intent
* patients must have completed at least 5 years and not more than 7 years of continued treatment with tamoxifen (20 mg/day), while tamoxifen could have been discontinued up to 6 months prior to study entry
* Absence of any evidence of local or distant metastatic disease was required prior to randomization

Exclusion Criteria:

* DCIS, bilateral breast cancer, evidence of metastasis, ER and Pgr negative
Management of the Sprained Ankle by Help of NSAID-Plaster

The purpose of this trial is to study the management of the sprained ankle by help of NSAID-plaster. A questionnaire. The effect of RICE and RICE + NSAID-plaster in the treatment of the sprained ankle, compared by pain-score.


Eligibility Criteria:
Inclusion Criteria:

* A sprained ankle, less than 24 hours old, understanding Danish, 18 years or older

Exclusion Criteria:

* Fracture of the ankle, wound around the ankle, allergy of NSAID- pregnancy, daily use of NSAID, GI-bleeding
Efficacy and Safety of FITpatch Compared to Standard Opioid Treatment in Cancer Pain (FT-015-IN)

Primary objectives:

* To determine non-inferiority of FITpatch with regard to efficacy compared to standard opioid treatment
* To assess the safety of FITpatch compared to standard opioid treatment

Secondary objectives:

* To assess the intake of oral morphine as rescue analgesic to FITpatch compared to standard opioid treatment
* To assess Quality of life reported with FITpatch compared to standard opioid treatment


Eligibility Criteria:
Inclusion Criteria:

Subjects that have insufficiently treated, cancer-related chronic pain that requires long-term treatment with an opioid at Step 3 on the WHO Ladder, and with Karnofsky performance status above 50.

1. Subject informed consent given.
2. Aged between 18 and 75 years, and for female subjects a proven negative pregnancy test and adequate contraception.
3. No significant skin lesions on relevant surfaces on the body or diffuse skin diseases.
4. No impaired respiratory function nor neurological or psychiatric impairment.
5. No known abuse of drug, narcotic or alcohol.
6. Not pregnant or nursing.
7. Not hypersensitive/allergic to fentanyl or morphine.
8. No head injury, primary brain tumor, increased intracranial pressure or impaired consciousness.
9. Not participating in other clinical trials.

Exclusion Criteria:

All exclusion criteria must be answered No for a patient to participate in the trial.

1. Does the patient have significant skin lesions on the upper arms/flat surface of the upper torso or diffuse skin disease (psoriasis or eczema) that preclude application of fentanyl patches?
2. Does the patient have a known abuse of drug, narcotic or alcohol?
3. Is the patient pregnant or nursing?
4. Has the patient neurological or mental impairment that may compromise data collection?
5. Is the patient hypersensitive/allergic to fentanyl or morphine or any of the ingredients in the trial medication?
6. Has the patient any major head injury, primary brain tumour, increased intracranial pressure or impaired consciousness?
7. Does the patient participate in other clinical with other investigational drugs or investigation al medical devices or has been participating in such a trial for the past 30 days?
Efficacy of Retrograde Fill Vs Spontaneous Fill to Assess Voiding Function

Purpose: The purpose of this study is to determine if two different methods of performing a postoperative voiding trial are equivalent in evaluating urinary retention after gynecologic surgery.

Participants: The participants in this study will be women who have undergone gynecologic surgery at UNC-Chapel Hill.

Subjects will be enrolled in the study when presenting to the UNC gynecology outpatient clinic for surgical preoperative evaluation. After surgery, each woman will undergo a voiding trial to assess for urinary retention after surgery. This is currently performed on all patients undergoing surgery involving prolapse or incontinence. At UNC this is usually performed by allowing the bladder to spontaneously fill, then allowing the patient to void and afterward catheterizing the patient to check a postvoid residual ("spontaneous fill" technique). In this study, we will also assess bladder emptying separately by filling the bladder retrograde through the catheter already in place with 300 mL of saline and then removing the catheter and allowing the patient to void ("retrograde-fill" technique). We will determine postvoid residual indirectly by subtracting voided volume from the 300 mL infused volume. No catheterization will be performed with this technique. Both of these techniques will be performed. The order in which the two techniques will be performed will be randomized. We will then compare the outcomes of these two techniques of voiding trials to see if they are equivalent in assessing urinary retention. Of note, the retrograde fill technique is standard at other institutions and is not considered experimental.

Eligibility Criteria:
Inclusion Criteria:

1. Women undergoing surgical correction of pelvic organ prolapse or urinary incontinence

Exclusion Criteria:

1. Unwillingness to participate in the investigation.
2. Inability to give informed consent.
3. Known preoperative voiding dysfunction
4. Plan for suprapubic catheter placement at time of surgery.
5. Age less than 18
6. Non-English speaking
Mindful Waiting Room

This will be a single-site, five-arm, parallel group randomized control trial involving patients seeking integrative healthcare. Four different styles of 5-minute, audio-recoded mindfulness practices delivered in the clinic waiting room will be compared with a 5-minute audio-recording about integrative healthcare.

A secondary sub-analysis will investigate the most effective mindfulness practice style for patients presenting at the clinic with elevated anxiety, depression, or pain.


Eligibility Criteria:
Inclusion Criteria:

* Seeking treatment at the Huntsman Cancer Institute's Wellness Center
* Adults 18+
* Facility with the English language that is adequate to complete study procedures

Exclusion Criteria:

* Cognitive impairment preventing completion of study procedures
* An unstable illness judged by medical staff to interfere with study treatment
Physical Activity Measure Application

Although there is a strong physiological rationale for the benefit of post-operative mobilization, the evidence supporting these effects in surgical cohorts is conflicting, and there is a lack of research to guide the clinical implementation of early mobilization protocols. There is also a need to better evaluate the physical activity performed by physical activity tients outside the supervised mobilization protocol, to better understand its potential benefits on post-operative recovery. In adition, the objective measurement of physical activity has several advantages over declarative measures.

Prolonged immobilization after surgery is known to have detrimental effects. Although postoperative recommendations favor early mobilization, the lack of quantification of physical activity poses a problem for the implementation of early mobilization protocols..

An application named "ACTIM" has been developed with the aim of automating the personalized assessment of postoperative physical activity. The healthcare team (nurses or physiotherapists...), will share the information with the patient and will complete the assessment using personalized physical activity objectives for the day.

The purpose of this study is to assess this application in real-life settings to provide patients with information on their physical activity after lung resection by thoracoscopy or robotic surgery. This assessment will serve as a reference for future studies.

Eligibility Criteria:
Inclusion Criteria:

* Patient 18 years of age or older
* Scheduled for thoracoscopic or robotic lung resection
* Agreeing to wear an ActiGraph GT3X accelerometer from 4 days post-surgery
* Having signed a consent form
* Affiliated with a health insurance

Exclusion Criteria:

* Pregnant or breastfeeding woman
* Patient unable to move independently (paraplegic, etc.)
* Patient deprived of liberty or under guardianship
Effects and Safety of Steam Eye Mask With Acupoints Stimulation

To evaluate the effects and safety of the steam eye mask with acupoints stimulation by the moist heat of approximately 40 degree C for 20 minutes and massage acupoints on eyebrows for eye fatigue, dry eye symptoms and symptom-induced decline of Quality of life (QoL) in VDT users.

A prospective study is conducted to evaluate the effect of the steam eye mask with acupoints stimulation on eye fatigue and dry eye symptoms in VDT users. The effects and safety of the single therapy by the moist heat of approximately 40 degree C for 20 minutes with eyebrows acupoints massage for the first 3 minutes are evaluated in the single application study, and the effects and safety of the repeated therapy by the moist heat applied and massage acupoints on eyebrows once per working day for two weeks are evaluated in the repeated application study.

Eligibility Criteria:
Inclusion Criteria:

1. Males or females aged from 20 to 69 years old (both inclusive).
2. Participants who use VDTs, including laptops, electronic tablets, readers and smartphones for 6 hours or more a day.
3. Participants who respond to the 16 symptoms of visual symptoms related to computer use in the working population for the total score over 6 based on a computer vision syndrome questionnaire.
4. Participants who respond to more than 1 of 12 typical dry eye symptoms by "constantly" or "often" based on a dry eye questionnaire.
5. Participants are able and willing to comply with all protocol requirements and procedures.
6. Participants who must be capable of providing informed consent document, with one's signature.

Exclusion Criteria:

1. Participants with eye diseases that could affect the ocular surface (e.g. Ocular inflammation, infectious conjunctivitis, allergic diseases, autoimmune diseases and collagen diseases).
2. Participants who have been treated by physicians because of eye diseases and do not recover from that disease yet at the moment of joining to this study, or participants who need to be treated by physicians because of eye disease.
3. Participants with the excessive meibomian lipid secretion (seborrheic MGD).
4. Participants with trauma, swelling and eczema at the skin around eyes.
5. Participants with allergic reaction for heating, abnormality of the heat or depression of the heat.
6. Participants who are deemed inappropriate to participate in this study by physicians.