cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Point-of-care Tests for the Diagnosis of Cutaneous Leishmaniasis in Afghanistan

New point-of-care (POC) tests are needed and assessing the performance of these tests for cutaneous leishmaniasis (CL) in Afghanistan may help increasing the number of CL patients with access to accurate diagnosis, and enable prompt treatment. Simpler tests could improve treatment access and benefit patients and communities, by reducing the risk of sequelae and the risk of disease transmission. CLeishPOCAFG aims to advance the diagnosis of CL by using more accurate and field-amenable methods.

The investigators enrolled 274 CL suspects in the study to determine the diagnostic performance of LoopampTM Leishmania Detection Kit and CL DetectTM Rapid Test for CL diagnosis in Afghanistan. The study was conducted at the National Malaria \& Leishmaniasis Control Program (NMLCP) Leishmaniasis Clinic in Kabul, Afghanistan.

Eligibility Criteria:
Inclusion Criteria:

* Clinical signs compatible with cutaneous leishmaniasis
* Age ≥ than two years old.
* Informed consent obtained and documented.
* Clinical samples can be obtained.

Exclusion Criteria:

* Age less than two years old.
* Failure to obtain and document informed consent.
* Cutaneous leishmaniasis suspects from whom, for any reason, the required clinical samples needed for the study cannot be obtained.
* Patients already receiving CL treatment at the time of enrolment.
Long-term Prognosis of Emergency Aneurysmal Subarachnoid Hemorrhage

Rupture of intracranial aneurysms can lead to extensive subarachnoid hemorrhage (SAH), a potentially fatal neurological emergency with mortality rates ranging from 8 to 67%. At present, surgical clipping (SC) and endovascular coiling (EC) are two main treatments for aneurysmal subarachnoid hemorrhage (aSAH), in recent years, the improvements in surgical equipment and techniques have already greatly improved the postoperative safety of patients. However, considering individual differences between patients, some still at risk due to possible complications during hospitalization or after discharge from the hospital, it will no doubt generate a large healthcare burden.

This prospective, observational clinical trial (LongTEAM) is to improve the diagnosis and treatment effect and efficiency in this field, reducing mortality, medical costs, and medical burden, while opening up new avenues for interdisciplinary clinical practice and scientific research exploration.


Eligibility Criteria:
Inclusion Criteria:

* All patients admitted to the emergency department of the investigator with aneurysmal subarachnoid hemorrhage are included in their prospective registry.

Exclusion Criteria:

* None
riSk Factors fOR neCk phlEgmon afteR pErcutaneous tRacheostomy in ICU

Primary Purpose: To investigate the incidence and risk factors related to the appearance of tracheal phlegmon in patients undergoing percutaneous tracheostomy.

Participant Population/Primary Condition: Patients admitted to Intensive Care

Main Questions Aims to Answer:

1. - What are the risk factors associated with the development of tracheal phlegmon percutaneous tracheostomy?
2. - How does the appearance of tracheal phlegmon impact intensive care stay, hospital stay, mortality, and Health-related quality of life?

Participants will be followed up after undergoing tracheostomy for 7 days to identify eventual phlegmons.

At the two-year follow-up, the health-related quality of life will be assessed


Eligibility Criteria:
Inclusion Criteria:

* Age greater than 18 years
* Presence of indication for tracheostomy

Exclusion Criteria:

* Failure of the percutaneous tracheostomy technique or recourse to surgical tracheostomy
Effects of Baby Massage on Parenting Stress and Attachment in Premature

This study is an experimental randomized controlled clinical trial. To explore the effect of infant massage on parental pressure and parent-child attachment of premature infants. The intervention time was from 5 days after birth to discharge from premature infants. Data were collected at five time points in longitudinal, before massage (T0), one week (T1), four weeks (T2), and eight weeks ( T3), 12 weeks (T4). Parents in the experimental group were given massage interventions when visiting premature babies, while parents in the control group visited premature babies as usual and contacted premature babies according to general nursing instructions.

The organ development of premature infants is not yet mature, leading to higher morbidity and mortality. Even with advanced technology, parents and families still need to put more effort into taking care of these premature babies so that they can survive. Empirical evidence indicates that baby massage can help parents reduce stress and establish parent-child relationships, but few studies have been applied to parents of premature babies during hospitalization. Based on this, the purpose of this study is: 1. To explore the effect of infant massage on reducing parental pressure; 2. To compare the gender differences of parental pressure; 3. To explore the effect of infant massage on parent-child attachment; 4. Compare the gender difference of parent-child attachment relationship between parents of premature infants. An experimental randomized controlled clinical trial study design was adopted to collect data at five points in time, namely before massage (T0), one week (T1), four weeks (T2), eight weeks (T3), and 12 weeks (T4 ). Using the parental stress scale and parent-child attachment scale. Parents in the experimental group were given massage interventions when visiting premature babies, while parents in the control group were routinely visiting premature babies. The effects of infant massage on parental pressure and parent-child attachment of premature babies at different time points were discussed, and the differences gender of parental pressure and parent-child attachment were compared. The results can increase the empirical research on baby massage, use the empirical knowledge to arouse the attention of nursing staff to baby massage, improve the quality of family-centered care, and pay attention to the needs of parents of different genders.

Eligibility Criteria:
Inclusion Criteria:

1. Single premature infants with a birth week of 30-37 weeks, weighing 1500-2500 grams;
2. The pediatrician assesses the stability of vital signs;
3. Premature infants without congenital abnormalities (such as congenital heart disease) or central nervous system dysfunction (such as intraventricular hemorrhage, epilepsy, etc.); Parents who meet the conditions for premature infants are the study subjects.

Exclusion Criteria:

1. Parents performing kangaroo care;
2. Parents younger than 20 years of age;
3. Parents with mental illness or substance abuse;
4. Single parent father or mother.
Pregnancy Outcome in Women With an Iron Deficiency in the First Trimester

The primary aim of this retrospective, monocentric study with two parallel groups is to investigate pregnancy outcome in women with iron deficiency in the first trimester. It compares the pregnancy outcome between pregnant women with an iron deficiency and those without an iron deficiency in the first trimester. The study group are pregnant women with a diagnosed iron deficiency in the first trimester, a total of 227 pregnant women. The control group consists of 486 pregnant women without first-trimester iron deficiency. Matching criteria include parity and maternal age. Data from patient files of pregnant women who were treated in the Women's Clinic, University Hospital Basel between 2017 and 2019 are analyzed.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women with a documented iron deficiency in the first trimester
* Pregnant women with normal hematological parameters and iron status in the first trimester
* Treated at the Women's Clinic, University Hospital in Basel

Exclusion Criteria:

* Pregnant women with a documented rejection
Polymorphisms in the Vitamin D System and Health

Polymorphisms in the vitamin D system appear to affect the serum 25(OH)D levels. If so one would expect these polymorphisms to be associated with vitamin D related conditions and diseases, which will be tested in the present study including DNA analyses in 9700 subjects

Vitamin D, which is essential in calcium metabolism, is produced in the skin after sun exposure or obtained from food, mainly fatty fish or vitamin D supplements. For activation vitamin D must be hydroxylated in the liver to 25(OH)D and thereafter in the kidney to 1,25(OH)2D. In the circulation 25(OH)D and 1,25(OH)2D are bound to a carrier protein (DBP), and for 1,25(OH)2D to exert its effect it has to bind to the vitamin D receptor (VDR).

The serum level of 25(OH)D, which is the metabolite used to evaluate a person's vitamin D status, is in part genetically determined and several polymorphisms with effects on serum 25(OH)D have been identified. These polymorphisms, where the minor allele frequencies vary between 16 and 40 %, appear as important for the serum 25(OH)D level as the effect of season, physical activity or vitamin D supplementation.

Vitamin D is not only vital for the skeleton, but appears to be related to a number of health outcomes, including mortality as previously demonstrated in the Tromsø study. However, as the serum level of 25(OH)D is strongly influenced by life-style factors that are also related to health outcomes, it is difficult to decide whether the relation between vitamin D and health is causal or not.

On the other hand, the polymorphisms are not influenced by life-style, and the effect of the polymorphisms will be life-long. Accordingly, they may be a better marker of vitamin D status than a single serum 25(OH)D measurement. Furthermore, there are a number of polymorphisms regarding the vitamin D receptor (VDR) that may be associated with health.

In the present study we will therefore relate the polymorphisms affecting the serum 25(OH)D level and the function of the VDR, with anthropometric and biochemical measures, mortality, diseases and risk factors for disease. DNA will be obtained from the 4th Tromsø study.

If we find the expected associations between the polymorphisms and diseases, this will further strengthen the role of vitamin D in human health, and may be important for recommendations regarding vitamin D supplementation. Considering the high prevalence of vitamin D deficiency world wide, this may potentially have huge consequences for public health.

The main purpose of the present study is the vitamin D system, but in the Tromsø study we have previously also found a number of associations between thyroid and androgen function and health. Obtaining DNA for analysis will be the major cost in the project, whereas analyses of individual polymorphisms are relatively cheap. We will therefore also include polymorphisms regarding thyroid and androgen function.

Eligibility Criteria:
Inclusion Criteria:

* participated in the fourth Tromsø study, later registered in our end point registry or selected as a control subject

Exclusion Criteria:

* lacking DNA sample
OTC Mouthpiece for Snoring

Online patient registration to participate in clinical trial to test OTC mouthpiece that controls position of the tongue to reduce snoring.

Patient will complete informed consent, inclusion/exclusion criteria, sleep apnea and snoring surveys online. If patient meets all criteria for the study, patient will be provided with a treatment device for use for a 10 day treatment period. Patient will complete the trial upon providing final online surveys.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years of age
* Living in the United States
* Signing the Informed Consent Form

Exclusion Criteria:

* Missing teeth (as the device won't be properly fitted)
* Any severe breathing or respiratory disorder, such as chronic asthma, emphysema, COPD, or a similar condition
* Poor dental health, such as severe gum disease, loose teeth, an abscess, mouth sores, or bleeding gums
* A dental implant placed within the last three months
* Diagnosed with a Temporomandibular joint condition (TMJ)
* Actively experiencing any mouth or jaw pain, including clenching of the teeth, grinding, or any other physical injury to the jaw or teeth
* Full dentures
* Braces
* Diagnosis of sleep apnea
* Less than 18 years of age
Autologous Human Adipose-Derived Mesenchymal Stem Cells in Alzheimer's Disease

This is a single patient emergency expanded access clinical study to assess the safety of administering autologous AdMSCs to an incurable Alzheimer disease patient. The study subject will be evaluated for disease-associated severity according to symptoms, cognitive function, memory, and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* The patient is diagnosed with later stage of Alzheimer Disease with sever cognitive disability.
* All current anti-Alzheimer medicines cannot prevent disease progression and the patient's mental and physical ability persistently declined
* Patient's legal guardian and caregiver must voluntarily sign an approved written consent form after ample explanation of the proposed therapy.

Exclusion Criteria:

* Current diagnosis of malignancy
* Renal/liver dysfunction: Exceed two times as normal subject
* Pregnant or nursing
* Received other trial drugs within 30 days after participation of this study
* Experienced major surgery or trauma in the last 14 days
N-acetylcysteine in the Treatment of PTSD and Addiction

Examine the effects of N-acetylcysteine on PTSD symptoms, craving and substance use in veterans with PTSD and comorbid substance use disorders.

With the increased number of military veterans returning from conflicts in Afghanistan and Iraq diagnosed with posttraumatic stress disorder (PTSD), there is a high vulnerability of these individuals to develop a substance use disorder (SUD). While there have been a host of studies focused largely on dopaminergic mechanisms of drug reward, they have not led to the development of adequate treatments for either preventing people diagnosed with PTSD from developing SUD or for treating comorbid PTSD/SUD. Based on extensive work with addictive drugs and preliminary data from our group, the investigators propose that stress impairs prefrontal cortex regulation of the basal ganglia habit circuitry and this pathology renders PTSD patients susceptible to developing SUD. Moreover, the known effects of addictive drugs to further impair prefrontal regulation are synergistic with this pathology, thereby making treatment of comorbid PTSD/SUD particularly difficult. Preclinical studies have revealed that glutamate levels within the nucleus accumbens have been implicated in drug seeking behavior in the animal model of relapse. The amino acid precursor N-acetylcysteine (NAC) appears to restore glutamate to normal levels and may also prevent glutamate levels from spiking following subsequent stimulant use. The primary goal of the proposed study is to evaluate the efficacy and safety of N-acetylcysteine in preventing relapse in drug dependent individuals with PTSD or subthreshold PTSD. Veterans with substance use disorders who have achieved at lease one week of abstinence will be randomized to either placebo or NAC (2400-3600mg/day) for 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* 18-65 year old
* U.S. military Veteran, Reservist, or National Guard member
* DSM-IV diagnostic criteria for current (past 6 months) SUD and PTSD or subthreshold PTSD (i.e., met criteria for cluster B (re-experiencing) and either cluster C (avoidance) or D (hyperarousal), as well as duration of one month and clinically significant impairment)
* Score of \> 21 on the Mini-Mental State Exam (MMSE).

Exclusion Criteria:

* Unstable medical conditions
* Bipolar or psychotic disorders
* Seizures or asthma
* Prior treatment with NAC
* Suicidality
* Enrolled in ongoing PTSD treatment (pharmacotherapy or psychosocial)
* Females: could not be pregnant or lactating
Neuromuscular Electrical Stimulation in Chronic Heart Failure Patient

The purpose of the study is investigate the effects of NMES in regulation of serum IL-6 and IL-15 in chronic heart failure patients who received standard inpatient cardiac rehabilitation protocol

Majority of chronic heart failure patients became intolerance of physical training that could limit activity. Recent studies reported that Neuromuscular electrical stimulation (NMES) application could increase muscle mass, oxidative enzyme, endothelial function, VO2 peak and quality of life in chronic heart failure patient. It was hypothesized that Neuromuscular Electrical Stimulation (NMES) assisted muscle contraction in chronic heart failure patients will increase the activity of myokine (Interleukin-6 and Interleukin-15), that in turn will promote exercise tolerance in this patient. the aim of this study was to investigate the effects of NMES in regulation of serum IL-6 and IL-15 in chronic heart failure patients who received standard inpatient cardiac rehabilitation protocol. Thirty chronic heart failure patients in cardiology ward that fulfilled inclusion criteria were randomized in two groups; the control group (standard inpatient cardiac rehabilitation protocol) and the intervention group (standard inpatient cardiac rehabilitation protocol and NMES). The intervention was done every day for seven days. Measurement of serum IL-6 and IL-15 were done before and after study, and analyzed by sandwich immunoassay with monoclonal antibody.

Eligibility Criteria:
Inclusion Criteria:

* heart failure patients admitted to the hospital NYHA II-III
* no weakness of lower limbs
* stable hemodynamic, already received standard treatment based on patient condition
* able to follow instruction
* lived at Surabaya or Sidoarjo
* assigned the informed consent

Exclusion Criteria:

* knee osteoarthritis with knee pain that interfere the ambulation
* phlebitis and active bleeding on lower limb
* use vasoactive drug (such as Dobutamin etc)
* already receive NMES before at femoris area in last 6 weeks before admission
* fracture of lower limb that interfere the ambulation
* sensory deficit at lower limb
* acute infection
Animal Assisted Therapy in Pediatric Dentistry

A prospective randomized trial measuring physiologic biometrics and perceptions of stress during a pediatric dental exam, cleaning, and simulated radiographs with or without a therapy dog present.

Patients will be consented, enrolled, and randomly assigned to a control group (no dog) or to an experimental group with dog present only before their dental visit for 3 minutes (+ Short AAT) or to an experimental group with dog present throughout their entire visit (+ Long AAT). Control (no dog) patients will have an active control where they color for 3 minutes before their dental exam, cleaning, and simulated radiographs, without a dog present. Biometric data will be collected with a small wireless wrist device (Shimmer 3) which measures heart rate and sweat response (skin galvanic response). Salivary samples will be taken before and after the dental visit to measure salivary cortisol and amylase, as a metric of physiological stress. Finally, a video feed of body movements during the dental visit will be collected for observational coding. Pre-visit and post-visit surveys will be given to all the patients on their experiences regarding pain, anxiety, and perceptions of the dental experience.

Eligibility Criteria:
Inclusion Criteria: Subjects must meet all of the following inclusion criteria to be eligible for enrollment in the study:

* 4-8 years of age
* English speaking
* Qualifies for a dental exam and prophylaxis (cleaning) by having not received a dental prophylaxis or oral exam in the past 3 months
* Stable physical health, decided at the discretion of the study coordinator and PI
* Able to comprehend and follow the requirements of the study (including availability on scheduled visit dates) based on research site personnel's assessment
* Evidence of a personally signed and dated informed assent form from the child and legal guardian's consent document indicating the subject (or legally acceptable representative) has been informed of all pertinent aspects of the trial and all of their questions have been answered

Exclusion Criteria: Subjects presenting with any of the following will not be included in the study:

* Patients \<4yo and \>8yo
* Non-English speakers
* Patients unwilling to assent/participate or parental/guardian consent was not given
* Self-report or parental report of patient suffering current dental pain
* Known allergies or significant adverse reactions following exposure to dogs or the use of oral hygiene products (toothpastes, mouth rinses), and all ingredients in prophy paste
* Children who are afraid of dogs or had a prior negative experience with dogs as reported by the parent or child
* Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or may interfere with the interpretation of trial results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this trial
* Developmental/cognitive disability such that patient cannot self-assent, comprehend and follow the requirements of the study based on research site personnel's assessment
The Effect of n-3 Polyunsaturated Fatty Acid Supplements in Patients With Non-alcoholic Fatty Liver Disease

The principal purpose of this study is to determine whether increased intakes of n-3 polyunsaturated (omega-3) fatty acids will reduce the amount of fat stored in the liver in patients with non-alcoholic fatty liver disease.

Non-alcoholic fatty liver disease (NAFLD) is present in 10-24% of the general adult population. The first step of NAFLD involves the accumulation of fat within the liver (steatosis). Steatosis occurs either due to defective generation, metabolism or excretion of fatty acids by the liver. The next step in NAFLD progression is inflammation, which commonly occurs due to pro-inflammatory stimuli. Persistent inflammation results in end-stage liver disease. NAFLD is associated with the metabolic syndrome, which is characterised by central obesity, insulin resistance, raised triglycerides and hypertension. With the current obesity epidemic, there is predicted to be greater numbers of patients with NAFLD in the future.

Polyunsaturated fatty acids (PUFAs) are essential components of our diet, though standard Western intakes are lower than the recommended amounts. Supplementing the long chain n-3 PUFAs (commonly termed omega-3), EPA and DHA, improves many of the metabolic syndrome features. They lower plasma triglycerides, and may improve insulin resistance.

The diet of NAFLD patients tends to be deficient in n-3 PUFAs and have an excessive intake of the harmful n-6 PUFAs. This pattern is mirrored in their liver lipid content as assessed at biopsy.

Currently there is no proven treatment for NAFLD. Animal studies and limited studies in patients have been supportive of a benefit with n-3 polyunsaturated fatty acids. This needs to be further assessed.

Eligibility Criteria:
Inclusion Criteria:

1. Age greater than 18 years
2. Liver biopsy diagnosis of NAFLD

Exclusion Criteria:

1. Excessive alcohol intake - \> 21 units per week in men and \> 14 in women
2. A further liver disease diagnosis
3. Poorly controlled diabetes - HbA1c \> 8.0%, or use of insulin sensitisers
4. Pregnancy
5. Cirrhosis
6. Contraindications to MR scanning - pacemaker or metallic foreign body etc.
7. Changes in the dose or initiation of lipid altering medication within the preceding three months, such as statins, fibrates or systemic steroids
8. Use of n-3 PUFA supplements within the prior 4 months, an adequate washout period
9. Significant co-morbid inflammatory illnesses as determined by research team