cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Long-Lasting Microbial Larvicides in Reducing Malaria Transmission and Clinical Malaria Incidence

In the past decade, massive scale-up of insecticide-treated nets (ITN) and indoor residual spraying (IRS), together with the introduction of artemisinin-combination treatments, have led to substantial reductions in malaria prevalence and incidence in African highlands. However, rising insecticide resistance and increased outdoor transmission have greatly hampered the effectiveness of ITN and IRS because the current indoor-based interventions do not target the outdoor-biting mosquitoes. Therefore, new supplemental interventions that can tackle outdoor transmission and pyrethroid insecticide resistance are urgently needed. The central objective of this study is to determine the efficacy and cost-effectiveness of EPA-approved long-lasting microbial larvicides in reducing malaria transmission and clinical malaria incidence in western Kenya highlands.

In the past decade, massive scale-up of insecticide-treated nets (ITNs) and indoor residual spraying (IRS), together with the use of artemisinin combination treatments, have led to major changes in malaria epidemiology and vector biology. Along with the significant reduction in overall malaria prevalence and incidence, extensive use of insecticides has created large selection pressures for resistance in the malaria vector populations and for potential outdoor transmission, which appears to be limiting the success of ITNs and IRS. Because IRS and ITN have little impact on outdoor resting and early biting vectors, outdoor transmission represents one of the most important challenges in malaria control. Therefore, new interventions that can augment the current public health measures to reduce outdoor transmission are urgently needed. Larval control has historically been very successful and is widely used for mosquito control in many parts of the world, except in Africa. Factors limiting the use of larvicides include high costs associated with frequent habitat re-treatment. Now a new US EPA-approved long-lasting formulation, potentially effective for 6 months is available. The central objective of this study is to determine the effect of long-lasting microbial larviciding on the incidence of clinical malaria and reduction of transmission intensity. Our hypothesis is that addition of long-lasting microbial larviciding to ongoing ITN and IRS programs will lead to significant reductions in both indoor and outdoor malaria transmission and malaria incidence.

Eligibility Criteria:
Inclusion Criteria:

* All clinical malaria cases from participated local hospitals and clinics.

Exclusion Criteria:

* Infants younger than 6 months.
Immunophenotyping From Blood of Patients Suffering From Chronic Degenerating Joint Diseases and Receiving LDRT

Patients suffering from chronic degenerating diseases are often treated by a plethora of NSAIDs, DMARDs, Biologicals, as well as combinations of these therapeutics. However, many patients are refractory to this treatment and suffer from chronic pain over years, leading to a worsening of the quality of live. The mobilization of these patients is one main goal in the therapy of these chronic and inflammatory diseases. Low dose radiation therapy (LDRT) is applied since more than one century for the local treatment of chronic degenerating joint diseases. The success of the treatment was described by many retrospective as well as pattern of care studies, respectively.

Local (only at the painful joint) low dose irradiation of the chronic patients results in most patients in a significantly reduced pain, not only direct after the therapy, but also lasting for more than 12 month in many cases. The patients experience enhanced mobility and increased quality of life. The molecular and cellular processes leading to the pain reduction are just fragmentarily analyzed. Our group revealed that macrophages are key players in radiation-induced immune modulation. Inflammatory macrophages exposed to low doses of radiation showed a reduced inflammatory capacity and attenuated an inflammatory microenvironment. Besides macrophages further immune cells are most likely involved in reduction of inflammation following LD-RT, as in vitro already shown for neutrophils.

The IMMO-LDRT01 study aims for the first time to analyze in detail the immune status of patients suffering from inflammatory, chronic joint diseases before, during and after LD-RT in a longitudinal manner. The multi-color flow cytometry-based assay will allow determining over 30 immune cell subsets and additionally their activation status. Further, biodosimetry will be performed with the whole-blood samples to get hints about dose that the immune cells are exposed to. This will be performed with national and international co-operation partners.

The IMMO-LDRT01 study is a prospective and observational study not influencing the standard therapeutic scheme and will provide hints how the LDRT affects besides local cells in the irradiated area also the systemic inflammatory response.


Eligibility Criteria:
Inclusion Criteria:

* Patients suffering and diagnosed for:
* painful shoulder syndrome (periarthritis humeroscapularis)
* painful elbow syndrome (Epicondylopathia humeri)
* benign achillodynia
* benign calcaneodynia
* arthosis (finger- , rhiz-, gon-, and anklearthrosis
* arthritis (gon- and anklearthrosis)
* Planned local low dose radiation therapy (LDRT) at the Department of Radiation Oncology, Universitätsklinikum Erlangen.
* Age at least 18 years

Exclusion Criteria:

* patients who are suffering or had suffered from any malignant diseases
* fertile patients who refuse effective contraception during study treatment
* persistent drug and/or alcohol abuse
* patients not able or willing to behave according to study protocol
* patients in care
* patients that are not able to speak German
The Effect of a Custom Pillow on Sleep Quality in Patients With Nonoperative Rotator Cuff Syndrome

The objective of this study is to determine if a pillow sleep aid improves sleep quality in the short term for patients who have shoulder pain from a rotator cuff injury and are being managed non-operatively.

Patients who have shoulder pain from a rotator cuff injury will be identified in the outpatient clinic and offered the chance to enroll in the study. Informed consent will be obtained. There will be two groups of patients in this study; those that receive the pillow sleep aid (the intervention group) and those that do not (the control group). The pillow sleep aid that will be investigated in this project is the "MedCline Shoulder Relief System," a product of Amenity Health Inc.. The pillow will be delivered to the intervention group at no cost. Patients in both groups will be prescribed the same physical therapy protocols. At the end of the trial period, patients in the control group will be offered the option to receive a pillow. Those that accept will be surveyed at similar intervals as the original intervention group.

Eligibility Criteria:
Inclusion Criteria:

* age \>18 and a diagnosis of rotator cuff syndrome which is being treated non-operatively.

Exclusion Criteria:

* history of prior shoulder surgery, receiving a corticosteroid injection at initial visit, lack of mailing address, non-English speaking patient, inability to sleep on one's side, preexisting clinical insomnia and obstructive sleep apnea.
Effect of Repeat Administration of Eslicarbazepine Acetate on the Pharmacokinetics of a Combined Oral Contraceptive

The purpose of this study is to investigate whether multiple-dose administration of eslicarbazepine acetate (ESL, BIA 2-093) 800 mg once-daily (QD) affects the pharmacokinetics and tolerability of the components of a combined oral contraceptive (ethinyloestradiol and levonorgestrel).


Eligibility Criteria:
Inclusion Criteria:

* Pre-menopausal female subjects
* Age 18-40 years, inclusive
* Body mass index (BMI) 19-30 kg/m2, inclusive
* Healthy as determined by pre-study medical history, physical examination, vital signs, complete neurological examination and 12-lead ECG
* Negative tests for HBsAg, anti-HCVAb and HIV-1 and HIV-2 Ab at screening
* Negative urine pregnancy test at screening and admission to each treatment period.
* Using one of the following methods of contraception: double barrier or intrauterine device

Exclusion Criteria:

* Subjects who have any contra-indication to the use of oral contraceptives
* History or presence of clinically relevant diseases, disorders or surgical history
* History of alcoholism or drug abuse
* Have used medicines within two weeks of admission to first period that may affect the safety or other study assessments, in the investigator's opinion
Subclavian Vein catheterization_Seldinger Vs Modified Seldinger

Seldinger technique is a minimally invasive technique in which the practitioner accesses the target vessel with a small bore needle, then dilates to the size required for the catheter. Contrarily, modified Seldinger technique(guiding sheath-over-the-needle technique) use needle that is covered with guiding sheath.

Both technique is widely used in central venous catheterization, however, few researches have been investigated to compare success rate or complications of both methods.

The major complications of central venous catheterization through subclavian vein, are unintended arterial puncture, pneumothorax, hemothorax, malposition of catheter etc,. We assume that using modified Seldinger technique (MST), guiding sheath is easily slid over the needle, providing stable route into the vessel lumen relatively.

We aimed to compare the Seldinger technique and modified Seldinger technique(MST) on success rate and complications during subclavian central venous catheterization in this prospective, randomized , controlled trials.

Eligibility Criteria:
Inclusion Criteria:

* patient scheduled for surgery under genearl anesthesia and subclavian vein central catheterization

Exclusion Criteria:

* Patient who does not agree to the study
* Inflammation or infection on catheterization site
* Contralateral diaphragmatic dysfunction
* Anatomic anomalies of subclavian artery or vein/clavicle
* Previous lung surgical history
* Patient who has ventriculoperitoneal shunt or chemoport on same side
* Patient who has pneumo/hemothorax or lung parenchymal disease
A Single-dose, Comparative Bioavailability Study of Two Formulations of Sarpogrelate HCl 300mg Tablets Under Feeding Conditions

A Single-dose, Comparative Bioavailability Study of Two Formulations of Sarpogrelate HCl 300mg Tablets Under Feeding Conditions

To evaluate the bioequivalence of two formulations of Sarpogrelate HCl 300mg, Anpl-one SR Tab. 300mg (Reference) and generic Sarpogrelate HCl 300mg (Test), after a single oral dose administration in healthy Thai volunteers under feeding condition: open label, single-dose, randomized, two-period, two-treatment, two-sequence, crossover, comparative bioavailability study

Eligibility Criteria:
Inclusion Criteria:

* Healthy, non-smoking, male and female subjects, 19 years of age or older
* BMI ≥ 18.0 and ≤ 30.0 kg/m2.
* Females who participate in this study will be of childbearing or non-childbearing potential

Exclusion Criteria:

* Know history or presence of clinically significant neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, genitourinary, psychiatric, or cardiovascular disease or any other condition which, in the opinion of the investigator, would jeopardized the safety of the subject or impact the validity of the study results
UED-A Videolaryngoscope vs. Glidescope Titanium for Elective Tracheal Intubation

The present randomized clinical trial wants to compare the efficacy and safety of UED-A videolaryngoscope to Glidescope Titanium for routinely tracheal intubation in 60 adults, in terms of successful rate, no. attempts and manoeuvre duration.


Eligibility Criteria:
Inclusion Criteria:

* Patients candidates for general anesthesia in elective general surgery
* Age over 18 years
* American Society of Anesthesiologists (ASA) physical status I-III.

Exclusion Criteria:

* Refusal to sign informed consent
* Paediatric population
* ASA physical status IV
* Emergency tracheal intubation
* Independent Predictors of difficult Videolaryngoscopy (Neck extension \< 80°, macroglossia, interincisor distance \< 3 cm, anatomical alterations of the neck, cardiac surgery, ear-nose-throat surgery)
An Electronic Pillbox for People With HIV

Anti-HIV drug regimens can be very complicated. This study will evaluate a new electronic pillbox designed to help people take their anti-HIV drugs correctly.

Recent advances in antiretroviral therapy have allowed for almost complete inhibition of viral replication in HIV-infected individuals. Unfortunately, the ability of the virus to rapidly mutate and become resistant to treatments necessitates the administration of multiple medications, in complex dosing schedules, to maintain viral suppression. Although adherence to these complicated treatment regimens is paramount, even the most vigilant persons often have difficulty maintaining these protocols for extended periods of time.

MedSignals™ is an electronic device that was designed to improve medication compliance among HIV patients. It allows convenient storage and transport of antiretroviral medications and functions as an aid to compliance by incorporating reminding alarms at dosing times and usage reporting functions. The system alarms at pill times, records pill-taking, communicates usage data to servers, and displays progress charts on personalized web pages. Four separately-controlled compartments are easily set for number of dosings per day and number of pills at each dosing. Thereafter, all alarms are relative to last lid openings, assuring intake is optimally spaced. Additional menu options can be set to advise when lids are opened, such as "take with food." Lid openings are time-stamped in memory. The cradle is permanently plugged into telephone and electrical lines for uploading of data and recharging, but the pillbox is portable and pocket-sized. Every day, sensors detect a phone line and upload usage data to servers, allowing authorized caregivers or the patient to observe compliance records. This trial will evaluate MedSignals' usability and functionality in increasing medication compliance in people infected with HIV.

Participants will be randomly assigned to one of three study groups; each group will contain 25 participants. One group will use MedSignals with all of its features, one group will use MedSignals with only alarm features, and the final group will not use any device. Participants will have 4 study visits over 9 weeks and one follow-up telephone call after 6 months. Assessments will include demographic and usability questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* HIV-infected for at least six months prior to study entry
* Currently taking at least one and not more than four antiretroviral medications (not including medications for prophylaxis or unrelated disorders)
* Understand the benefits of antiviral medications in reducing viral load, boosting immune response, and preventing opportunistic infections
* Desire to take all antiretroviral medication as scheduled
* Working telephone
* Ambulatory
* Good mental health

Exclusion Criteria:

* Require assistance dispensing or taking medications
* Require full or part time assistance with the activities of daily living
* Does not intend to take all anti-HIV medication over the course of the study
Epidural Morphine Versus Epidural Fentanyl Infusion Following Cesarean Section

For post-Cesarean analgesia, the investigators will compare the efficacy of single-shot epidural preservative free morphine with a continuous epidural fentanyl infusion. The investigators will be comparing the patient's pain level and satisfaction with the two techniques, as well as the side effects that the patients experience, such as itching, nausea, back pain and respiratory depression.

Included in the study will be all healthy (ASA I or II) woman having elective Cesarean sections who are candidates for regional anesthesia. Exclusion criteria include morbid obesity (BMI \> 40), age less that 18 years, history of sleep apnea, and abuse of or intolerance to opioid analgesics.

All patients will also receive 100 micrograms of fentanyl once epidurally during the Cesarean section, and they will receive ibuprofen every six hours for the first 24 hours after the Cesarean section. The patients will be visited twice a day postoperatively for two days. The epidural morphine will be expected to last only approximately 20 hours, while the fentanyl infusion will be kept in place for two days after the procedure. Additional analgesics, such as intravenous morphine or PO oxycodone and tylenol, will be available for breakthrough pain.

Eligibility Criteria:
Inclusion Criteria:

* Patients having an elective Cesarean section
* Healthy women (ASA I or II)
* Regional anesthesia candidates

Exclusion Criteria:

* Morbid obesity (BMI\>40)
* Sleep apnea
* Age under 18
* Intolerance or addiction to opioids
Study Project Comparing the Sequelae of COVID-19 Infection in Patients Who Have and Have Not Received Ventilatory Support in Critical Care

To assess the proportion of post-intensive care syndrome (PICS) of patients who received high flow humidified oxygen with FiO2 ≥50% for more than 48h and / or who received mechanical ventilation for more than 48h in a context of hospitalization in intensive care for COVID-19 pneumonia


Eligibility Criteria:
Inclusion Criteria:

-

Group 1: patients hospitalized in intensive care units for ARDS with SARS-CoV-2

* Major
* Admitted between March 1 and May 10, 2020 in one of the sectors of the Bicêtre hospital approved for critical care
* proven SARS-CoV-2 infection
* Treated by invasive mechanical ventilation or high flow humidified oxygen with FiO2 ≥50% for more than 48 hours.

Group 2: patients hospitalized outside intensive care units

* Major
* Admitted between March 1 and May 10, 2020 in an area of Bicêtre hospital having cared for patients infected with SARS-CoV-2 excluding critical care: pulmonology, internal medicine / orthopedics, infectious diseases, nephrology , acute geriatrics, neurology.

Exclusion Criteria:

* Patients having refused the post consultation at 3 month
* Without social security coverage
Effect of Growth Hormone (GH) on Cardiac Echos in GH Deficient Patients After Acromegaly Treatment

The purpose of this research study is to study the effects of growth hormone (GH) replacement on the heart. The investigators will study these effects in people who have been cured of acromegaly and then have developed growth hormone deficiency (GHD, not enough growth hormone).


Eligibility Criteria:
Inclusion Criteria:

* age 18-75
* history of acromegaly with biochemical cure
* growth hormone deficiency

Exclusion Criteria:

* untreated thyroid disease within the past 3 months
* untreated adrenal insufficiency within the past 3 months
* uncontrolled hypertension
* congestive heart failure
* gonadal steroid therapy within the past 3 months
* pregnancy or nursing
Cost of Off-label Antibiotics in Osteoarticular Infections

Due to the emergence of multidrug-resistant micro-organisms in patients with bone and joint infection (BJI), the prescription of off-labeled antibiotics seem to be more and more common as part of routine care. These new antibiotics are, however, more expensive, and there are no precise data in France regarding the volume and cost of such off-label prescriptions in hospital, in the post-acute care structures, and in the outpatient setting.

The objective of this study is to estimate the cost of using these antibiotics over 2 years for patients in a reference center for the management of complex bone and joint infection (CRIOAc)


Eligibility Criteria:
Inclusion Criteria:

- Patients having had off-label antibiotics between 2014 and 2015 to treat bone and/or joint infection, with or without implant and managed at the CRIOAc Lyon

Exclusion Criteria:

None
Long-term Follow-up Study of Patients Who Received hLB-001 Gene Therapy

This is a non-interventional long-term follow-up study of patients who have participated in LogicBio studies for the treatment of MMA and received hLB-001

Patients will be followed for a period of 15 years which includes the duration of time that the patient was in the treatment study.

Eligibility Criteria:
Inclusion Criteria:

* Participant has previously participated in a LogicBio clinical trial and received hLB-001.

Exclusion Criteria:

* None
Tidal Model's Effects on Emotion Regulation and Recovery

The aim of this study is to investigate the effectiveness of Tidal Model-based emotion regulation interventions on recovery in individuals diagnosed with depression and nursing diagnosis of impaired mood regulation. The research was designed as a randomized controlled trial.

The main hypothesis; After nursing interventions for emotion regulation based on the Tidal Model, there is a significant difference between the recovery, difficulty in emotion regulation, depression levels and nursing outcome criteria of individuals in the intervention and control groups.

The research carried out with patients followed in psychiatry outpatient clinics. As a result of the G-power analysis, the sample consisted of 23 interventions and 23 control groups. In the study, while the control group received only routine treatment, in the intervention group, Tidal Model-based nursing interventions were applied in addition to the routine treatment. Pre-tests administered before individuals were randomly assigned to the intervention and control groups. Randomization was created using the website randomizer.org. After this randomization was created, it was hidden from the physician who made the diagnosis of depression and from the researcher who conducted the interviews (allocation concealment). After the pre-tests were completed, the researcher (consulting faculty member) who knew the random assignment order was reached and the individuals were randomly assigned to the control or intervention group. Tidal Model-based nursing interventions were structured as 8 sessions in total. Each individual in the intervention group participated in a session for a total of 8 weeks, one session per week. In the eighth session, post-tests were applied to the individuals in the intervention group. Individuals in the control group were asked to come back 8 weeks after the first interviews and post-tests were applied. All interviews were conducted face to face. Recovery Assessment Scale (RAS), Difficulties in Emotion Regulation Scale (DERS), and Nursing Outcomes Criteria (NOC) were used.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of moderate Depression according to Diagnostic and Statistical Manual of Mental Disorders (DSM)-V criteria
* Having a nursing diagnosis of Impaired Mood Regulation
* Psychiatrist prescribing serotonin reuptake inhibitor (SSRI)
* Man or Women aged 25-55
* Being followed by the psychiatry outpatient clinic
* Able to provide written informed consent

Exclusion Criteria:

* Presence of an additional mental illness
* Diagnosis of severe Depression according to DSM-V criteria
* Presence of suicidal attempts or thoughts
* Presence of another physical illness that affects cognition
* Have received any kind of therapy in the last six months
* Voluntary involvement in another study at the same time
* Inability to read and write