cyrilzakka/clinical-trials huggingface dataset:
Treatment of Mucosal Bolivian Leishmaniasis

The purpose of this protocol is to conduct a randomized comparison of the efficacy and tolerance of miltefosine, LAMB, and pentavalent antimony for the treatment of mucosal leishmaniasis. With such controlled pharmacodynamic data, and additional considerations of administrative convenience (oral \>\>IV) and cost, we hope that it will be possible for policy makers, treatment professionals, and patients to choose the most appropriate therapy for ML.


Eligibility Criteria:
Inclusion Criteria:

* weight over 45 kg
* Parasitological confirmation of the lesion will be made by visualization of Leishmania, culture of Leishmania, or molecular identification of Leishmania (PCR) from the biopsy or aspirate of the lesion.

Exclusion Criteria:

* Previous treatment for leishmaniasis in the last 12 months
* concomitant diseases by history that would be likely in the PI's opinion to interact, either positively or negatively, with treatment
* values of complete blood count, liver function (aspartate aminotransferase, alkaline phosphatase), renal function (creatinine), pancreatic function (lipase), or uric acid beyond 1.5 x normal range
* EKG with clinically significant abnormalities
* Women of childbearing age not agreeing with the use of secure reproductive contraception for 4 months after initiating miltefosine therapy.
Long-term, High Blood Flow Hemoadsorption Therapy in Patients Undergoing Maintenance Hemodialysis

Objective：The purpose of the study is to confirm that extending the duration of hemoadsorption (HA) and increasing blood flow during the HA+hemodialysis (HD) treatment process is safe and feasible, and to verify that extending the HP treatment duration can further increase the clearance of protein-bound uremic toxins.

Methods: The study employs a multicenter, prospective, cohort design with a self-controlled before-and-after comparison. The duration of HA+HD treatment for maintenance hemodialysis (MHD) patients is extended to 4 hours, and the extracorporeal blood flow rate is increased to over 250-350 ml/min. The safety of the treatment is assessed by evaluating the safety of the procedure; the levels of relevant toxins in the patients' blood are measured before and after treatment, and the clearance rate of uremic toxins after a single treatment is calculated and compared with the self-controlled before-and-after data to determine whether the modified protocol can remove more uremic toxins.


Eligibility Criteria:
Inclusion Criteria:

Maintenance Hemodialysis Patients with Uremia receive regular HA+HD treatment

Exclusion Criteria:

Plasma albumin \<30g/L, severe malnutrition or cachectic state; platelet count \<40×10\^9/L or \>300×10\^9/L; hypercoagulable state allergy to the hemoperfusion device; new cardiovascular or cerebrovascular diseases; poor vascular access function, extracorporeal circulation blood flow unable to reach 250ml/min ultrafiltration volume \>4500ml in a single dialysis session use of non-heparin anticoagulants inability to comply with the procedures of this study other conditions deemed unsuitable for participation in this study by the investigator

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Mechanism of Endothelial Dysfunction in Obstructive Sleep Apnea (OSA)

The investigators hypothesized that patients with Obstructive Sleep Apnea (OSA) who are free of any cardiovascular disease will have early microcirculatory changes that are unique to OSA, and therefore would resolve with treatment of OSA.

Impaired vascular regulation of the microcirculation is a consequence of Obstructive Sleep Apnea (OSA). Nitric Oxide (NO) related endothelial dysfunction occurs in OSA as the earliest vascular abnormality prior to the manifestation of vascular disease and it results in impaired vasodilatory response to hypoxia. These abnormalities have already been described in OSA patients. The role of oxidative stress in endothelial dysfunction is present in vascular disorders. The presence of oxidative stress in OSA patients is also well established. The effect of increased superoxide on endothelial function has also been described in the literature. The mechanism of this effect is unknown and is the focus of this research.

We hypothesized that patients with Obstructive Sleep Apnea (OSA) who are free of any cardiovascular disease will have early microcirculatory changes that are unique to OSA, and therefore would resolve with treatment of OSA.

Eligibility Criteria:
Inclusion criteria:

1. Apnea-Hypopnea Index (AHI) \> 15 events per hours.

Exclusion criteria:

1. Hypertension defined by existing treatment with antihypertensives or any measurement of systolic pressure above 130 mmHg, or diastolic pressure above 85 mmHg;
2. Dyslipidemia defined by fasting cholesterol above 200; or fasting LDL over 150 mg/dl;
3. Diabetes defined as existing diagnosis, hemoglobin A1C \>7 or fasting glucose \>110 on two separate measurements (standard fasting glucose or HbA1C criteria);
4. CAD defined by history of angina, coronary event or abnormal stress test;
5. Peripheral Vascular Disease (PVD) defined by history of stroke, claudication or abnormal Ankle brachial index;
6. Concurrent smoking;
7. Pregnancy;
8. Use of erectile dysfunction drugs, or any medications for chronic conditions; 9)Chronic liver or renal disease. Fasting blood test for glucose, cholesterol, on all participants who have not had these tests in the 6 month prior to enrollment, will be obtained at the time of screening. The remaining criteria will be evaluated by reviewing the medical records and history taking on the day of first visit.
Pharmacokinetics of Topical SB204 in Adolescents With Acne Vulgaris

A Phase 1, Single-center, Open-label, Pharmacokinetic, Safety and Tolerability Study of SB204 in Adolescents with Moderate to Severe Acne Vulgaris

This is a single-center, open-label study to be conducted in 18 otherwise healthy adolescents with moderate to severe acne vulgaris. Repeat blood samples will be obtained on Day 1 and Day 21 pre and post treatment to characterize systemic exposure to hMAP3 and nitrate. Subjects will receive a low-nitrate diet for 12 hours prior to and during the PK sampling period

Eligibility Criteria:
Inclusion Criteria:

* Otherwise healthy male and female adolescent subjects with moderate to severe acne vulgaris on a 5 point IGA scale
* At least 20 total inflammatory lesions (papules and pustules), and at least 20 total non-inflammatory lesions (open and closed comedones) on the face, chest, back, and shoulders
* Age 9-16 years, 11 months inclusive
* Subjects with methemoglobin level less than 3% at Screening and Baseline by pulse co-oximeter

Exclusion Criteria:

* Subjects with any other acne-like dermatological conditions such as severe, recalcitrant nodulocystic acne, acne conglobata, acne fulminans, acne secondary to medications or other medical conditions, perioral dermatitis, clinically significant rosacea, or gram-negative folliculitis;
* Any subject with skin disorders of an acute or chronic nature including psoriasis, eczema, tinea versicolor, etc.
* Subjects who reside in a dwelling that relies on well water for a primary drinking source
* Subjects with facial hair (beards, mustaches, etc.), tattoos or other facial markings that would interfere with assessments and study drug application
* Transgender subjects receiving hormone supplement (male to female or female to male)
* Subjects with a previous history of methemoglobinemia or taking medications known to be associated with methemoglobinemia
* Subjects with a known history of HIV, hepatitis, or other blood-borne pathogens
* Females who are pregnant, planning a pregnancy or breastfeeding
* Subjects previously treated with NVN1000 Gel / SB204
Description of Chronic Pain in Emergencies Room and Medical Care Modalities

The rate of patients with chronic pain (CP) is 40% in patients with acute pain in emergency department (ED). Patients with CP come more frequently to ED than patients without CP. Reasons for their visit to ED are often in relation with this CP. Few studies have been interested to management modalities of these patients in ED. The investigators are going to realize a prospective observational study in one center. The hypothesis is that patients with chronic pain are less satisfied of ED management that patients without CP.

Chronic pain is defined by a daily pain since more than 3 months. CP is different of acute pain because of their mechanisms, treatments and therapeutic objectives. CP is associated with an alteration of quality of life with psychological, social and economic consequences. The prevalence of CP in France is 15%. In ED, the rate of CP in patients with acute pain was around 40%. Patients with CP come more frequently to ED than patients without CP. Their use of care structures, particularly ED, is all the more frequent that their disability is important. The satisfaction of these patients in ED is associated with age, nature of pain, wait duration, realisation of imaging, and administration of painkillers and relieving of pain. The reasons why these patients go to ED were pain exacerbation, inadequate strategy of coping, severity of disease and sometime despair associated with stress or anxiety. Currently the investigators do not know if these managements in ED are adequate or not. And finally the investigators do not know whether the satisfaction about their ED management is different from patients without CP. The investigators are going to collect data about all patients admitted in ED with the objective to compare the satisfaction between patients with CP and patients without CP. The follow up will be restricted to the area of ED. The last data will be collected just before the exit from ED.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old or more admitted in ED
* between 8 am and 5pm
* from Monday to Friday.

Exclusion Criteria:

* Patients admitted directly in emergency intensive care for vital distress defined by hemodynamic, respiratory, or neurological failure distress,
* multitrauma patients;
* patient without possibility to communicate because of neurologic disease or mental status disease;
* linguistic barrier.
Total Wrist Denervation: Survival Study and Functional Outcomes

The purpose of the study is to evaluate the long-term effectiveness of total wrist denervation on pain by assessing the surgery survival.

The residual functional wrist's quality and the patients' satisfaction will also be evaluate.

The degenerative diseases of the wrist are numerous and include both post-traumatic osteoarthritis lesions and inflammatory diseases. In any case, one of the main reasons for consultation is pain. In case of inefficiency of a well-conducted medical treatment (splints, anti-inflammatories, infiltrations), surgical management remains difficult because of the multitude of treatments that can be offered: partial or total arthrodesis of the wrist, prosthetic arthroplasties, pyrocarbon implants or proximal row carpectomy. But these treatments are heavy and can potentially be sources of complications such as stiffness, loss of strength or progressive wear of the implant.

Total wrist denervation is an alternative since 1966. The original technique follows an anatomical study of the innervation of the upper limb. This technique has been proven to significantly improve pain without major after effects. Several teams demonstrated a decrease in pain associated with conserved strength and mobility, but few studies have studied the long-term results of this technique, especially on the absence of residual pain.

The purpose of this study is to evaluate the long-term effectiveness of denervation on pain by assessing the surgery survival, the residual functional wrist's quality and the patients' satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* patient undergoing total wrist denervation between January 1995 and December 2013 at Brest CHRU, performed by the same senior surgeon

Exclusion Criteria:

* patient who had another intervention at the same time (confounding factor)
* refusal expressed by the patient to participate in the study
Oxycodone Extended-release in the Treatment of Perioperative Pain in Patients Undergoing Orthopaedic Surgery

Inadequate control of acute postoperative pain (DAPO) brings deleterious consequences for the patient, including significant cardiovascular and respiratory complications. Apart from the human suffering that is undeniable pain. Schemes oral analgesia with opioids for the treatment of DAPO, have shown to be as or more effective than intravenous or epidural regimes, and less expensive. Comparing the effectiveness of 10 to 20 mgs of oxycodone sustained release for 12 hours before surgery, into two groups of 20 patients (O-10, O-20) undergoing orthopedic surgery, in a scheme involving multimodal ketoprofen, dipyrone metoclopramide and dexamethasone. Values were recorded visual analog scale (VAS)for pain at rest and effort, requirement for rescue intravenous morphine and incidence of side effects to the entry and exit of the PACU (T0, TE) and at 6 and 18 hours postoperatively (T6, T18),and patient satisfaction.


Eligibility Criteria:
Inclusion Criteria:

* ASA I and II patients between 18 and 60 years old, both sexes, undergoing elective orthopedic surgery.

Exclusion Criteria:

* Use of psychotropic medication or illicit drug use
* Pregnancy
* Liver disease
* Opioid use
* History of postoperative nausea and vomiting
* Ileus
* Allergy or intolerance to any of the study drugs
* Physical or mental inability to use the pain scale, or any surgical complications.
Pain, Anxiety of Aromatherapy and Music Effect on

The research is planned as a randomized controlled trial. The main question\[s\] it aims to answer are:

\[question 1\]: Does the inhaler effect of music and aromatherapy applied to palliative care patients have an effect on pain, anxiety and vital signs?

The individuals in the research group are divided into four groups as music group, aromatherapy group, music and aromatherapy and control group. .

Before and at the end of the intervention, data collection tools \[Patient Description Form, Visual analog scale,face anxiety scale, Distress Thermometer, Edmonton Symptom Scale\] will record the characteristics of pain, anxiety and vital parameters.

Patient Identification Form: It is a questionnaire that includes sociodemographic characteristics (gender, age, educational status, income status, employment status and occupation) and questions about the disease, created by the researchers by scanning the literature.

The relaxing music group listened to specially composed "MusiCure®" compositions in soft rhythm, including melodies with harp, cello, strings and sound elements from nature (eg rain, bird, forest sound).The patients in the experimental group listened to music with headphones for 20 minutes for three consecutive days.Pain, anxiety and vital parameters were recorded with data collection tools \[Patient Description Form, VAS, FAS, Distress Thermometer, Edmonton Symptom Scale\] before and at the end of the intervention.For the patients in the aromatherapy group, use 5% lavender oil with a diffuser for 15-20 minutes.

has been applied.The diffuser was placed 30 cm from the participants and five (5) drops of essential lavender oil were placed on the filter paper. Within 10-15 minutes after the completion of the inhalation, data collection forms were applied again and pain, anxiety, blood pressure, pulse and respiratory rate were evaluated.The patients hospitalized in the palliative care service were given music with a loudspeaker for three consecutive days with the effect of aromatherapy inhaler.

Within 10-15 minutes after the completion of the inhalation, data collection forms were applied again and pain, anxiety, blood pressure, pulse and respiratory rate were evaluated.

Eligibility Criteria:
Inclusion Criteria:

* who volunteered to participate in the research,
* 18 years and older,
* No hearing problem
* Doesn't have any problems with smelling healthy,
* No communication and speech problems

Exclusion Criteria:

* with a diagnosis of psychiatric illness,
* Allergic to lavender, perfumes or cosmetics,
* Having asthma and chronic obstructive pulmonary disease
Placebo-Controlled Trial of Safety and Efficacy of Thalidomide in Patients With Infections Due to Mycobacterium and/or HIV

To demonstrate, in patients with tubercular or nontubercular mycobacterium infections with or without HIV infection, the safety of thalidomide use as judged by symptoms, physical exam, and studies of microbiologic, immunologic, hematologic, renal, and hepatic status. To demonstrate efficacy of the drug as judged by status of fever, nutrition, tuberculosis lesions, and immune responses.

Patients are randomized to receive thalidomide or placebo orally at 9 PM the night before beginning anti-tuberculosis chemotherapy and continuing nightly for 7 nights. Patients are followed for 28 days. Patients are stratified according to HIV status and stage of HIV infection.

Eligibility Criteria:
Inclusion Criteria

Patients must have:

* Positive AFB smear and/or culture for Mycobacterium tuberculosis, M. avium, or other mycobacterial infection, with or without documented HIV infection. NOTE:
* HIV-positive patients must have CD4 count \< 500 cells/mm3 and be on antiretroviral therapy.
* One of the following manifestations:
* Temperature over 38 C on at least two occasions in the week prior to study entry.
* Recent weight loss of more than 5 kilograms.
* Pulmonary involvement of one or more lobes or involvement of other tissues due to tuberculosis or other mycobacterial infections, or symptomatic infections related to HIV status.
* Night sweats on two or more occasions in the week prior to study entry.

NOTE:

* Patients must be hospitalized men aged 18-65 and postmenopausal women to age 65. Anticipated requirement for hospitalization must be at least 10 days.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Neuropathy or other disorders with risk of neuropathy.

Required for HIV-positive patients if CD4 count \< 500 cells/mm3:

* Antiretroviral therapy.
Dose-ranging Study of SKF7™ for Obesity

This study has been designed as a randomized, double blinded, multi-centric, placebo controlled, and phase II dose-ranging study. The herbal drug contains bioactive ingredients from Labisia pumila plant and it is an aqueous ethanolic standardized extract (SKF7™).

Labisia pumila or Kacip Fatimah is a native Malaysian and Indonesian plant. It has been used as traditional medicine for over 400 years by both men and women for multiple treatments including toning and firming the abdominal area. As a water-ethanol dry extract, it has been reported to reduce body weight, cholesterol level and triglyceride level, and regulate blood glucose and sex hormones. In Malaysia, this Kacip Fatimah extract has been used as a natural anti-obesity drug and dietary supplement for healthy weight loss and healthy body by the trade-name of Labeesity® or SKF7™. This extract has been shown to be pesticide / herbicide free and has branded halal ingredient identity and security.

Eligibility Criteria:
Inclusion Criteria:

1. Men aged 18 - 50 yrs or women aged 18 until before perimenopause, with obesity
2. Willing to participate in the study by signing the informed consent
3. Healthy by anamnesis
4. Agreed to maintain their current lifestyles (no changes in their diet and physical exercise) during the clinical trial period.

Exclusion Criteria:

1. Positive result for Rapid test for COVID-19 at screening period.
2. Known hypersensitivity to any herbal product.
3. Pregnant or lactating women.
4. Taking any other weight loss therapy and/or lipid lowering products.
5. Participate in other interventional clinical study or have taken other investigational drug within 30 days prior to screening.
Efficacy of Vestibular Physiotherapy Against Multi-component Exercise in Functional Improvement in the Elderly

Loss of vestibular function occurs normally with healthy aging but can produce symptoms that reduce motor skills and cause falls. vestibular physical therapy (VPH) exercises are a specific approach to reducing imbalances. The multicomponent therapeutic physical exercise (ME) is an effective non-pharmacological strategy for the improvement of physical condition.

Objective: to determine the efficacy of ME versus VPH for gait improvement. Material and method: a randomized clinical trial was carried out with two intervention groups , applying it to one VPH group and the other ME.

The participants were residents of Geriatric Centers in the province of Seville, Spain with a score between 4 and 9 points according to the "Short Physical Performance Battery" scale (SPPB).

This pilot study is a controlled and randomized clinical trial (simple ER) with two groups in parallel, comparing the combination of a multi-component therapeutic exercise protocol (ME) versus vestibular exercises (VPH) in over 70 years. The trial was approved by the Ethics Committee on Research with code 2410-N-19 and the study was conducted in accordance with the Helsinki Declaration.

Eligibility Criteria:
Inclusion Criteria:

* Males and females over 70 years of age.
* Subjects with a score between 4 and 9 points on the. "Short Physical Performance Battery"" (SPPB) scale

Exclusion Criteria:

* Patients unable to walk unaided or those who do not exceed the previous evaluation in SPPB.
* Polypharmacological patients (combined use of beta blockers, sulpiride or betahistin) were also excluded.
Sublingual Analgesia for Acute Abdominal Pain in Children

Acute abdominal pain is a frequent symptom in children admitted to the emergency department . In the past the fear of masking a surgical condition has justified withholding analgesia in patients with acute abdominal pain. By the 2000s, some clinical trials established that opioid analgesia before surgical consultation does not affect diagnostic accuracy or outcome in children with acute abdominal pain. Despite this, acute abdominal pain is still undertreated in this setting. Published paediatric trials studied the effect of opioid analgesia administered by parenteral route or by mouth. To the best of our knowledge no study investigated the effectiveness of sublingual analgesia.

The purpose of this randomized controlled trial is to assess the effectiveness of three different drugs (ketorolac, tramadol, paracetamol), administered by the sublingual route, in children complaining of acute abdominal pain.


Eligibility Criteria:
Inclusion Criteria:

* Age 4 to 18 years
* Emergency department admission for moderate to severe acute abdominal pain (VAS/NRS score \>=6)
* Informed consent signed by parents or legal guardians

Exclusion Criteria:

* Known allergy or sensitivity to nonsteroidal anti-inflammatory drug, opioids or acetaminophen
* Use of analgesic drugs in the 8 hours before
* Clinical suspicion of abdominal pain due to fecal stasis
* Moderate or severe dehydration (weight loss of more than 5%)
* Known nephropathy, liver disease, metabolic or neurologic disease
* Thrombocytopenia or history of bleeding disease