cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Fosmidomycin-Clindamycin for Treating Malaria in Gabonese Children

There is a necessity for the development of new malaria drugs. Some antibiotics are also effective against malaria parasites. Fosmidomycin is an antibiotic that has been shown to be effective against malaria, although it cannot achieve a total cure in all patients. Previous small studies have shown that in combination with clindamycin, an commonly used antibiotic, it is highly effective and safe when given for three days, leading to a total cure in most patients. The current study will evaluate its efficacy in a larger population in Gabon, and compare its effect with the generally used drug, sulfadoxine-pyrimethamine.

Fosmidomycin-clindamycin (30 mg/kg and 10 mg/kg) given twice daily for three days is an effective and safe combination of antibiotics which demonstrated good activity against malaria parasite in previous phase II studies in African children. In this phase III trial, the efficacy and safety of the combination will be evaluated in African children with uncomplicated P. falciparum malaria. A single dose of sulfadoxine-pyrimethamine, the standard antimalarial in Gabon, is used as comparator.

Eligibility Criteria:
Inclusion Criteria:

* Uncomplicated P. falciparum malaria
* P. falciparum asexual parasitaemia between 1,000/µL and 100,000/µL
* Body weight between 10 - 65 kg
* Ability to tolerate oral therapy
* Informed consent, oral assent of the child, if possible
* Residence in study area

Exclusion Criteria:

* Adequate anti-malarial treatment within the previous 7 days
* Antibiotic treatment for the current infection
* Previous participation in this clinical trial
* Haemoglobin \< 7 g/dl
* Haematocrit \< 23 %
* Leucocyte count \> 15,000 /µL
* Mixed plasmodial infection
* Severe malaria (as defined by WHO)
* Any other severe underlying disease (cardiac, renal, hepatic diseases, malnutrition, known HIV infection)
* Concomitant disease masking assessment of response
* History of allergy or intolerance against trial medication
Local Heat-Stress as a Mechanism of Hearing Preservation

This pilot study plans to determine whether or not local heat-stress as a mechanism can help to preserve hearing in adults treated with Cisplatin.

Evidence from the laboratory over the past 10-15 years has demonstrated that heat stress to the ear is otoprotectant against a variety of insults. The strongest evidence supports heat-shock protein 70 (Hsp70) as a key facilitator in this protection. Hsp70 is well established as a cell stabilizer, especially for cells undergoing significant stress. Hsp70 has been shown to protect against cisplatin-induced ototoxicity. Induction of Hsp70 may be accomplished pharmacologically, by whole-body heat stress, or by local heat stress. A form of local heat-stress is already employed in the common clinical setting of the warm caloric. This vestibular test has been in place since the early 20th century with a variety of studies evaluating the patient vestibular response to a variety of times and temperatures. Current clinical practice recommends either water or air calorics of 45°C or 50°C (respectively) at 45-60 seconds.

Several studies have described administering prolonged caloric stimulation to individual subjects without ill effect. Patients are able to tolerate stimulation up to 60 minutes without intolerable nystagmus or vertiginous symptoms or significant injury. Thus, it is feasible to provide warm stimulus to the ear for the recommended time of 30 minutes at the recommended temperature of 50°C (air) without significant risk to the patient.

The purpose of this study is to evaluate the impact of heat stress to the inner ear as an otoprotectant intervention against cisplatin-induced hearing loss. Patients that meet inclusion criteria will be offered audiometric evaluation before each cisplatin treatment and at 1, 3, 6, and 12 months following their chemotherapy. Patients will undergo their heat-stress 5-7 hours prior to their cisplatin treatment. Patients will serve as their own controls with one ear randomly receiving treatment and the other not. The primary outcome will be audiometric testing. Blood samples will be collected for serum levels of Hsp70 as a secondary outcome. A sample size of 12 achieves 80% power to detect a 0.9 standard deviation difference between ears using a two-sided paired t-test at 0.05 significance level.

Eligibility Criteria:
Inclusion Criteria:

* Any patient undergoing total cisplatin in total doses \> 100mg/m2.
* Written consent.
* Age \> 19 years.

Exclusion Criteria:

* Inability to tolerate the intervention
* Exposure to cisplatin treatment without intervention.
* Head and neck carcinoma
* Baseline asymmetric hearing loss.
* Pregnant or breastfeeding women.
Ambulatory Laparoscopic Sleeve Gastrectomy

In the era of laparoscopic surgery, day case procedures are increasingly practiced around the world, however, day case bariatric surgery remains a controversial issue due to lack of sufficient evidence evaluating its safety. Laparoscopic sleeve gastrectomy (LSG) is currently the most popular bariatric surgery performed worldwide, and the standard is 1-2 days postop stay. However, the American College of Surgeons and the American Society for Metabolic and Bariatric Surgery released guidelines in 2016 that allowed LSG in ambulatory surgery centers for low acuity patients. In the present trial, investigators will compare the safety and feasibility of same day discharge vs next day discharge in a large group of patients undergoing laparoscopic sleeve gastrectomy.

This is a 2-group, randomized, open label clinical trial patients who will be recruited at an ASC to undergo LSG with same-day discharge, termed Ambulatory Surgery Center LSG (ASC LSG) or LSG with conventional hospitalization and next day discharge (CH LSG). The study will recruit participants between December 2018 and December 2020. Data collected will include including age, body mass index (BMI), operative time, recovery room time, hospital stay, readmission, follow up visits, ASC visits, adverse events, and re-operation rates.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 and 65 years
2. Body mass index \<60
3. American Anesthesiologists Association classification ≤III
4. Commitment to stay within close proximity to the ambulatory surgery center for 4 days after surgery

Exclusion Criteria:

1. High risk for thromboembolic disease
2. Has a history of major open abdominal surgery
3. Bleeding disorders
4. Heart disease
5. Pulmonary hypertension
6. Uncontrolled type 2 diabetes
7. Severe obstructive sleep apnea
8. Chronic obstructive pulmonary disease
The Effect Of Therapeutic Touch On Loneliness and Hopelessness

The effect of therapeutic touch applied to hemodialysis patients on the level of loneliness and hopelessness is being investigated. It encourages nurses to practice therapeutic touch.

Chronic diseases are a challenging process that affects human life physiologically and psychologically. Chronic Renal Failure, which shows a significant increase in the world and in our country, also affects human life in every aspect. Hemodialysis treatment is used with a high rate in the treatment of patients diagnosed with End Stage Renal Failure.

Hemodialysis patients experience loneliness and hopelessness during their difficult and compulsory treatmet. Fear of being alone is an important problem affecting the patient's compliance with treatment. In addition, the other problem these patients experience is hopelessness. Hopelessness is an important factor that affects the patient's expectations for the future and the process of solving problems.

Therapeutic touch is a complementary and alternative treatment method. It is stated that this treatment method, which is successfully used by nurses, is good for loneliness and hopelessness. This method, which will be used on hemodialysis patients, is aimed to get away from the problems of loneliness and hopelessness.

In this study, two scales will be used to measure the loneliness and hopelessness levels of hemodialysis patients. Patients will fill in UCLA Loneliness Scale and BECK Hopelessness Scale.

Nurses should not ignore the problems of loneliness and hopelessness in hemodialysis patients. Therapeutic touch treatment method wil lprovide nurses the holistic caregiver role for the feelings of loneliness and hopelessness experienced by the patients. When the literature is scanned, this study is unique because it has not been done before on hemodialysis patients.

Eligibility Criteria:
Inclusion Criteria:

* Having hemodialysis treatment for at least 3 months,
* Cognitive patients,
* Having a score of UCLA\> 20 and BECK≥4 scoring,
* Involved in the work with us.

Exclusion Criteria:

• Patients using traditional treatment for the disease were not included in the study.
Automated Administration of Fluids Guided by Dynamic Parameters and Cardiac Output During General Anesthesia

The main objective of this study is to demonstrate that the LIR (Learning Intravenous Resuscitator) Closed-Loop Fluid Administration System (hereafter the "LIR system"), a new device for the automated administration of intravenous fluids during major abominal surgery and which allows the reinjection of 250 ml of saline filling (crystalloid or colloid), maintains blood volume at values that are acceptable by the "gold standard", i.e. the anesthetist in charge of the patient.

This is a prospective, bi-center, open "Phase II" type study on a medical device (the LIR system). It is the first trial of the device on humans.

The study, which begins at the signing of consent (made the day before or the day of surgery), ends when the patient leaves the hospital. The LIR system is used on a small population of patients under general anesthesia for the automated administration of intravenous fluids during major abdominal surgery by laparotomy or laparoscopy. Several criteria describing the fluids administered, cardiac output, blood pressure and other parameters will be identified during surgery.

This Phase II study is carried out in two, subsequent stages of size "n1" = 19 and "n" = 42.

Strengthening of security :

* The device will be used under the direct supervision of an anesthesiologist ; he / she can regain control instantly when needed .
* An independent oversight committee will be formed and consulted every 10 patients.

Eligibility Criteria:
Inclusion Criteria:

* The patient must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* The patient will receive general anesthesia for a surgical procedure with the following characteristics: ----- planned abdominal surgery by laparotomy or laparoscopy with a probable duration\> 2 hours ----- invasive monitoring of blood pressure ----- administration of crystalloid and colloid (HEA PM \<150 kDa)

Exclusion Criteria:

* The patient is participating in another study
* The patient is in an exclusion period determined by a previous study
* The patient is under judicial protection, under tutorship or curatorship
* The patient refuses to sign the consent
* It is impossible to correctly inform the patient
* The patient is pregnant, parturient, or breastfeeding
* The patient has a contraindication for a treatment used in this study: ----- Contraindications to the administration of HES MW \<150 kDa ----- Patient classified NYHA\> 2 ----- Allergy to HEA
* The patient has a pacemaker
* Surgery with cardiopulmonary bypass
* Surgery on the skull
* Dementia
* Patients with brain pathology (tumor, stroke, Parkinson's disease, ...)
* Patients with a psychiatric disorder, severe depression or psychosis, as well as those receiving antipsychotic treatment
* Limitations concerning the use of respiratory pulse pressure variation: cardiac arrhythmia, spontaneous ventilation, using a volume flow \<7 ml / kg
Steroids and/ or Non-steroidal Anti-inflammatory Drugs in the Postoperative Regime After Trabeculectomy.

PURPOSE:

Glaucoma is the leading cause of non-curable blindness globally. Patients with glaucoma will get a gradual narrowing of the visual fields caused by compression at the optic nerve head due to increased intraocular pressure. Thus the main preventive strategy is to reduce intraocular pressure, initially by eye drops and/or laser treatment but in some patients surgery is warranted. The surgical procedure (trabeculectomy) most widely performed worldwide creates a path from the anterior chamber to the subconjunctival space and thereby lowers the IOP by producing a more efficient drainage of the aqueous humour. Surgical success depends upon controlling post-operative inflammation to ensure a functional drainage. The purpose of this blinded, randomized study is to investigate which anti-inflammatory treatment provides better long-term control of intra-ocular pressure (IOP) following glaucoma surgery (trabeculectomy) by comparing topical NSAIDs to topical steroids. Additionally, we want to explore the mechanisms behind the pathophysiology of glaucoma by evaluating retinal and optic nerve head perfusion before and after IOP lowering surgery. The primary outcome is the intraocular pressure 12 months after surgery measured by applanation tonometry.

MAIN HYPOTHESIS:

* NSAIDs and steroids are equally effective in assuring long-term filtering function and controlling IOP after trabeculectomy but may be associated with different risk profiles and bleb morphology
* Patients with lower post-operative IOP demonstrate less progression of visual field loss
* Trabeculectomy lowers IOP and provides better microcirculation in and oxygenation of inner retinal layers (i.e. ganglion cell layer) and the optic nerve head


Eligibility Criteria:
Inclusion Criteria:

* Patients with primary open-angle glaucoma (POAG), pseudoexfoliation syndrome (PEX), pigment dispersion syndrome (PDS) or ocular hypertension
* \>50 years
* Women must be postmenopausal. Women are asked if they have menstruated within the preceding 12 months
* Scheduled to undergo trabeculectomy surgery at the Department of Ophthalmology at Rigshospitalet-Glostrup, Denmark
* Informed consent to participation and ability to comply with study procedures

Exclusion Criteria:

* Known allergy to any of the contents of the pharmaceuticals (active and in-active ingredients) used in the study
* Prior intraocular surgery, except from cataract surgery. If cataract surgery has been performed, it should at least be 6 months prior to surgery
* Medical history of anterior segment dysgenesis, inflammatory/uveitic glaucoma, angle closure glaucoma, neovascular glaucoma and traumatic glaucoma
* Steroid responders
* Pregnancy
* Fertile women, i.e. women who are not menopausal and women who breastfeed
* Patients in systemic treatment with steroid or NSAID
Effect of Photobiomodulation for Patients With Xerostomia

Hyposalivation is a condition represented by a reduced salivary flow and may include symptoms such as mouth dryness (xerostomia), pain, loss of taste,dysphagia, and dysphonia, all of which greatly affect an individual's quality of life.

The aim of the present study was analized the effects of low-level light therapy irradiation (photobiomodulation PBM) on salivary gland function in patients with hyposalivation

Inclusion criteria -the inclusion criteria for participating in the study were: age over 18 years; continuous xerostomia for over three months; and/or altered sialometry findings at baseline (salivary flow \< 0.1 mL/min).

Exclusion criteria. : xerostomia as secondary to radiotherapy; patients with decompensated systemic disorders or cognitive problems

The 60 individuals will be randomized in 2 groups: Group A (30 individuals submitted to treatment with a PBM) and Group B (30 individuals submitted to simulated PBM). A total of 60 patients with xerostomia were enrolled in the study and cited once a week for a period of 6 weeks treatment with diode laser (810nm, 6J/cm2) or sham treatment (according to the group).

Eligibility Criteria:
Inclusion Criteria:

* the inclusion criteria for participating in the study were: age over 18 years; continuous xerostomia for over three months; and/or altered sialometry findings at baseline (salivary flow \< 0.1 mL/min).

Exclusion Criteria:

* The exclusion criteria were: xerostomia as secondary to radiotherapy; patients with decompensated systemic disorders or cognitive problems
Cognitive Multi-Tasking Training in Healthy Older Adults

This study evaluated the feasibility of a remote web-based ecological cognitive training protocol to healthy older adults. The training protocol involves 5 training sessions.

Previous research demonstrated the relevance in training cognitive abilities that typically decline with age, such as those associated with executive control (e.g., abstract thinking, selective and divided attention, planning, task-switching and inhibitory control). The aim of the present study is to investigate the feasibility of a web-based cognitive training focused on executive control to cognitively healthy older adults. The participants will undergo the web-training in a daily type situation of meal preparation (i.e., Breakfast Game). The training protocol combines the tasks of table setting and cooking in a multi-tasking fashion. In some sessions Emphasis Change approach will be apply to the training, in order to assess it feasibility and potential effects in optimizing the performance. In addition, participants will undergo a brief web-based cognitive evaluation before and after training. If feasible, the investigators protocol will allow training older adults in critical cognitive skills for daily life situations. The web-based training is an advancement since it can be delivered at-home, remotely supervised, and is easily scalable. Recently, remote interventions have been particularly relevant to older adults due to the COVID-19 pandemic, which may limit in-person research participation.

Eligibility Criteria:
Inclusion Criteria:

* Cognitively healthy older adults

Exclusion Criteria:

* Low test scores (below 26 on the Montreal Cognitive Assessment - MoCA)
* Presence of certain medical conditions (i.e., major neurological or psychiatric disorder, or a medical condition that may impact cognitive functioning).
* Subjects which English is not the primary language, or with lack of capacity to consent will not be enrolled.
Twenty-Four Month Extension Study of BA058-05-003 (Abaloparatide) in Participants With Osteoporosis

The purpose of this study is to provide 24 months of standard of care data on participants previously enrolled in Study BA058-05-003 (NCT02653417).

To assess the long-term effect of the anabolic drug, abaloparatide-subcutaneous (SC) versus placebo in the prevention of bone fracture after cessation of treatment. Participants who completed the 18-month Double-Blind BA058-05-003 (ACTIVE) study (NCT02653417), after receiving abaloparatide-SC or placebo, were enrolled in this extension study to receive 70 mg of alendronate (bisphosphonate) weekly for an additional 24 months. Complete details for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.

Eligibility Criteria:
Inclusion Criteria:

1. The participant was enrolled, randomized to either the abaloparatide-SC (BA058) or placebo arm, and successfully completed Study BA058-05-003 (NCT02653417).
2. The participant was no more than 40 days from End-of-Treatment (Month 18) in Study BA058-05-003 (NCT02653417).

Exclusion Criteria:

1. Participants who were withdrawn from Study BA058-05-003 (NCT02653417) for any reason.
2. Participants who experienced a treatment-related serious adverse event (SAE) during Study BA058-05-003 (NCT02653417).
The COVID-19 Mobile Health Study (CMHS)

This study evaluates a brand-new cell phone-based auto-diagnosis system, which is based on the clinical guidelines, clinical experience, and statistic training model. We will achieve secure and 1st hand data from physicians in Wuhan, which including 150 cases in the training cohort and 300 cases in the validation cohort.


Eligibility Criteria:
Inclusion Criteria:

* High risk of COVID-19
* RT-PCR test result of SAR2-CoV-19

Exclusion Criteria:

* Not available for RT-PCR test result of SAR2-CoV-19
Effects of Pelvic Belt and Kinesio Tape on Pain and Functional Mobility in Pregnancy-Related Pelvic Girdle Pain

This study investigates the effects of pelvic belt (PB) and kinesio taping (KT) applications on pain and functional mobility in pregnancy-related pelvic girdle pain (PGP), in comparison with the control group that received only pain neuroscience education and ergonomic training.

Although there is strong evidence in the literature that pelvic support belts reduce pain in pregnancy-related pelvic girdle pain, no study investigating its effect on functional mobility with performance-based measurement methods or investigating its effectiveness on kinesiophobia has been found. Studies investigating the efficacy of KT in pregnant women with PGP are few and many are methodologically weak studies, most of which do not contain randomization and control groups. Also, no study has been found in the literature, which compares the effectiveness of PB and KT in pregnant women with PGP. Therefore, the primary aim of this study is to examine the effects of PB and KT on pain and functional mobility in pregnant women with PGP in comparison with the control group, which is only given pain neuroscience education and ergonomic training. The secondary aims are to investigate the effects of these applications on kinesiophobia, activity limitation and sleep quality; and to compare the groups in regard to patient compliance and treatment satisfaction levels of the groups.

Eligibility Criteria:
Inclusion Criteria:

* being able to read and write in Turkish
* being in 2nd or 3rd trimester of pregnancy
* having PGP for more than one week
* signing the informed consent form for the study

Exclusion Criteria:

* visual, auditory or cognitive problems which may prevent participation to the study
* health problems other than pregnancy-related PGP (orthopedic, neurologic, cardiorespiratory, etc.) or trauma history, which may affect standing from sitting, walking or stair climbing activities
* any gynecological or urological problems which may mimic pregnancy related PGP
* any diagnosed pregnancy complications other than PGP (preeclampsy, hypertension, diabetes,placental/fetal anomaly, preterm labor, etc.)
* high risk pregnancy (multiple gestation, etc.)
* history of spinal injury, ankylosing spondilitis, rheumatoid arthritis, intervertebral disc pathology)
* A positive straight leg raise test result, as well as sensory or motor deficits indicating intervertebral disc pathology
* history of prepregnancy low back or pelvic girdle pain
* using any analgesic or myorelaxant medication
* contraindications to KT or PB (impaired skin integrity or lesion in the lumbopelvic and abdominal regions, history of allergic reaction, etc.)
* previous KT (abdominal or lumbosacral) or PB experience
Kangaroo Care Reduces Infant Pain Caused By Vaccination

The aim of this randomized controlled study determine the effect of KMC on pain in infants during vaccination.

Infants undergo many painful procedures from the time they are born. Kangaroo mother care (KMC) is one of the nonpharmacological methods that are effective in alleviating pain. The aim of this randomized controlled study determine the effect of KMC on pain in infants during vaccination. The study subjects were 128 healthy, 1-month-old infants and their mothers. A sociodemographic questionnaire, the Neonatal Infant Pain Scale (NIPS), a pulse oximeter, and a chronometer were used in collecting the data. This study indicate that KMC reduced crying duration, heart rate, and pain in vaccinated infants, whereas it increased oxygen saturation levels in the blood.

Eligibility Criteria:
Inclusion Criteria:

* The consent of the parents to participate in the application of the study,
* The infant being 1 month old
* Parents and infants being healthy

Exclusion Criteria:

* The consent of the parents not to participate in the application of the study,
* The infant not being 1 month old
* The parents and infants not being healthy.