cyrilzakka/clinical-trials huggingface dataset:
Chamaemelum Nobile 2% Versus Placebo Topic Gel to Treat Oral Lichen Planus

Oral lichen planus (OLP) is a chronic inflammatory mucocutaneous disease characterized by outbreaks or flares. It affects 0.2-1.9% of the population. Although the etiology is unknown, the pathogenesis of OLP is known to involve an immune disorder, with epithelial damage caused by cytotoxic CD8 + lymphocytes. Clinically, the disease is characterized by different types of lesions - papular, reticular and in the form of plaques - that can alternate with erosive and/or ulcerative areas. A variety of treatments have been proposed for OLP: topical or systemic corticosteroids, cyclosporine, retinoids, azathioprine, tacrolimus, pimecrolimus, photochemotherapy and surgery. Patients with symptomatic OLP often require intensive therapy to reduce the signs and symptoms. The disease can produce considerable morbidity and alter patient quality of life, particularly in the presence of ulcerative lesions.

There is no fully resolutive and effective treatment - the management strategy focusing on the use of drugs that counter tissue inflammation and the underlying immunological mechanisms. The main inconvenience of these treatments is represented by the side effects they usually produce.

The purpose of this study was to evaluate that if Chamaemelum Nobile a can be used in the treatment of oral lichen planus. This could be useful as Chamaemelum Nobile has no reported side effects and hence it can used in place of steroids which are commonly used for this condition and have many reported adverse effects.

Eligibility Criteria:
Inclusion Criteria:

1. Patients clinically \& histopathologically diagnosed to be suffering from oral lichen planus.
2. Patients who had symptoms i.e. pain and/or burning sensation secondary to oral lichen planus.
3. Patients not on any treatment for the same. In case they were, then such treatment was stopped and a washout period of two weeks was given.

Exclusion Criteria:

1. Patients suffering from any systemic disease/s like
2. Patients with any other mucosal disease or any other skin disease which may be associated with oral lesions.
3. Patients on any drug therapy which may cause lichen planus like lesions.
4. Patients with findings of any physical or mental abnormality, which would interfere with or be affected by the study procedure.
5. Patients with a known allergy or contraindication to study medications
A Phase I Study to Study the PK and Safety of Single Doses of STS101, DHE Injection and Nasal Spray in Healthy Subjects

Single-center, single-dose, open-label, 2-part, 3-period crossover (in each part), pharmacokinetic and safety study.

Phase 1, open-label, 2-part, single-dose pharmacokinetic and safety study of STS101 in healthy subjects. Part 1 was designed to identify a dose level of STS101 for administration in Part 2. Subjects in Part 1 received 3 ascending doses of STS101 in a 3-period crossover manner. During Part 2, subjects received the dose of STS101 selected from Part 1, 1.0 mg DHE mesylate IM injection, and 2 mg DHE mesylate nasal spray in a randomized, 3 period crossover manner.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 50 years of age at the time of enrollment.
* Signed the informed consent document.
* Subject judged to be healthy by a qualified physician

Exclusion Criteria:

* Abnormal physical findings of clinical significance at the screening examination
* Significant abnormal laboratory values at the Screening Visit.
* Clinically significant symptoms or conditions that may have placed the subject at an unacceptable risk as a participant in the trial, or that may have interfered with the absorption, distribution, metabolism or excretion of the IMP.
Volasertib in Japanese Patients With Acute Myeloid Leukemia (AML)

To investigate safety, tolerability, maximum tolerated dose of volasertib in Japanese patients with AML


Eligibility Criteria:
Inclusion criteria:

1. Patients with diagnosis of AML (except for acute promyelocytic leukemia, APL) according to the World Health Organization definition and with one of the following features at screening

   * Relapsed or refractory AML
   * Untreated AML patients not considered to be suitable for standard induction therapy according to investigator's judgement
2. Male or female patients of age \>/= 18 years at the time of informed consent
3. Eastern Cooperative Oncology Group performance status score 0 - 2 at screening
4. Signed written informed consent consistent with Japanese Good Clinical Practice.

Exclusion criteria:

1. Patients with APL
2. Patients in the third or later relapse
3. Prior stem cell transplantation
4. Treatment with systemic therapy for the primary disease (including an investigational drug) within 14 days before the first dose of volasertib with the exception of hydroxyurea, or lack of recovery from any acute toxicities or clinically significant adverse events pertinent to the prior systemic therapy
5. Treatment with gemtuzumab ozogamicin within 6 weeks before the first dose of volasertib
6. Concomitant medication/treatment with anti-leukemic chemotherapy (systemic or intrathecal), radiotherapy, immunotherapy, or any investigational agent while receiving study treatment
7. Other malignancy requiring treatment at the time of screening
8. Clinical central nervous system (CNS) symptoms deemed by the investigator to be related to leukemic CNS involvement or requiring treatment
An Effectiveness and Safety Study of Cyclobenzaprine HCl Alone or in Combination With Ibuprofen for Acute Back or Neck Muscle Pain With Muscle Spasm

The purpose of this study is to evaluate the effectiveness and safety of cyclobenzaprine HCl 5 mg (muscle spasm medication) taken three times a day, alone or in combination with ibuprofen 400 mg or 800 mg (pain relief medication) taken three times a day, for the treatment of back or neck muscle pain with muscle spasm.

The objective of this multicenter, randomized, open-label, parallel-group, one-week study is to evaluate the effectiveness and safety of cyclobenzaprine HCl 5 mg three times a day for one week, alone or in combination with ibuprofen 400 mg or 800 mg taken three times a day, for acute back or neck muscle pain with muscle spasm. The primary measurement of efficacy is the subject-rated global impression of change after seven days of treatment, compared to baseline. Safety assessments during the study include the monitoring of adverse events, and a physical examination, assessment of vital signs and medical history of any present illnesses conducted during the baseline visit. The study hypothesis is that there will not be a statistically significant difference in patient ratings of global impression of change, muscle spasm, muscle pain, medication helpfulness, and functional ability, between the cyclobenzaprine HCl monotherapy group versus the cyclobenzaprine HCl/ibuprofen 400 mg and cyclobenzaprine HCl/ibuprofen 800 mg groups, for the treatment for acute back or neck muscle pain with spasm. Patients receive cyclobenzaprine HCl 5 mg administered orally three times a day for one week, or cyclobenzaprine HCl 5 mg with ibuprofen 400 mg administered orally three times a day for one week, or cyclobenzaprine HCl 5 mg with ibuprofen 800 mg administered orally three times a day for one week.

Eligibility Criteria:
Inclusion Criteria:

* Experiencing neck or back pain for no more than 14 days
* Physician rating of the muscle spasm of the neck or back region as mild, moderate or severe
* Ability to discontinue all muscle relaxants, NSAIDs (anti-inflammatory drugs) and pain relievers, other than the study medications during the 7-day treatment period. (Cardioprotective doses of aspirin (\<= 325 mg / day) may be taken.)

Exclusion Criteria:

* History of physician-diagnosed musculoskeletal neck or back muscle spasms within 12 months prior to the study
* neck or back pain radiating into the arms or legs
* history of serious medical conditions
* taken a narcotic or muscle relaxant within 12 hours of the baseline physician visit
* allergies to aspirin, NSAIDs or cyclobenzaprine HCl.
Evaluation of Venous Thromboembolism (VTE) Prophylaxis in Medically Ill Patients

VTE prophylaxis is not as routinely employed in medically ill patients as compared to surgical patients. This retrospective chart review project will evaluate the effectiveness of VTE prophylaxis in medically ill patients at the University of Utah Hospitals and Clinics compared to current literature. The study will ultimately serve as a quality improvement project to help improve patient care.


Eligibility Criteria:
Inclusion Criteria:

* Hospitalized at the University of Utah on one our medical services.

Exclusion Criteria:

* Patients received therapeutic anticoagulation.
Efficiency and Safety of Water Birth

Water birth are not risks factors for newborns.

Investigators will study medical records of woman who have water birth and evaluate different parameters. Study lasts from February 2020 till April 2021. The questionnaire contain information about woman's expectations of labour Number of participant is approximately 500.

Eligibility Criteria:
Inclusion Criteria:

* delivery alive newborn in water
* age 18-45
* single pregnancy

Exclusion Criteria:

* antenatal death
* dead fetus
* age under 18 and up 45
* multiple pregnancy
* somatic diseases
* preeclampsia
* mental diseases
Effects of Oral Supplementation With Creatine on Systemic Microvascular Endothelial Function in Vegetarian Individuals

The present study aims at investigating the effects of the oral supplementation with creatine on the systemic microvascular reactivity and plasma levels of homocysteine in vegetarian individuals of the vegan type.

A vegetarian is an individual who lives on a diet of grains, pulses, legumes, nuts, seeds, vegetables, fruits, fungi, algae, yeast and/or some other non-animal-based foods, with or without, dairy products, honey and/or eggs. A vegetarian does not eat foods that consist of, or have been produced with the aid of products consisting of or created from, any part of the body of a living or dead animal. This includes meat, poultry, fish, shellfish, insects, by-products of slaughter\*\* or any food made with processing aids created from these.

There are different types of vegetarian: i) Lacto-ovo-vegetarians eat both dairy products and eggs; this is the most common type of vegetarian diet; ii) Lacto-vegetarians eat dairy products but avoid eggs; iii) Ovo-vegetarians eat eggs but not dairy products; iv) Vegans do not eat dairy products, eggs, or any other products which are derived from animals.

Vegetarian individuals are considered to have lower cardiovascular risk for the development of cardiovascular diseases and lower cardiovascular mortality, when compared to omnivore individuals.

Nevertheless, some vegetarian diets may result in the deficiency of micronutrients and induce deficiency in some compounds such as vitamins, amino-acids, iron, zinc, calcium, omega-3 fatty acids and so on.

Moreover, vegetarian individuals can present deficiency in amino-acids such as carnosine and creatine, present essentially in the skeletal muscle of animals. In this context, deficiency in creatine has been considered as a risk factor for hyperhomocysteinemia and the consequent dysfunction of the vascular endothelium.

Hyperhomocysteinemia also is known to be an independent risk factor for cardiovascular diseases similar to hypertension, smoke and dyslipidemia.

In the present study, we investigate the effects of creatine supplementation in the systemic microvascular endothelial function and density in vegan-vegetarians presenting with normo- or hyperhomocysteinemia using laser-based skin flowmetry and video-capillaroscopy. We also investigate the effects of creatine supplementation on lipid and glycemic profile and plasma homocysteine levels.

Microvascular reactivity is evaluated using a laser speckle contrast imaging system in combination with the iontophoresis of acetylcholine (ACh), for the noninvasive and continuous measurement of cutaneous microvascular perfusion changes.

Microvascular density in the skin is evaluated using intravital video-microscopy.

Eligibility Criteria:
Inclusion Criteria:

* healthy vegetarians of the vegan type

Exclusion Criteria:

* previous treatment with dietary supplements
* high intensity physical activity
The Effects of Mesenchymal Stem Cell Secretome in Rheumatoid Arthritis Patients

This research is a clinical trial of administering mesenchymal stem cell secretome to rheumatoid arthritis patients.

This research is experimental. The research subjects were 30 rheumatoid arthritis patients. The control group received a placebo, and the treatment group received mesenchymal stem cell secretome on the 1st, 2nd, 3rd, 4th, 5th, 6th, 7th, 14th, 21st, and 28th. The data collected were erythroblastic acidity, hsCRP, interlukin 6, DAS-28, and assessment of drug side effects before and after therapy. Statistical test with paired difference test with p\<0.05

Eligibility Criteria:
Inclusion Criteria:

* Rheumatoid Arthritis Patients

Exclusion Criteria:

* Pregnancy
Influence of Keratoconus on Stress at Work

Keratoconus is a progressive disorder in which central and paracentral corneal stromal thinning occurs.

No studies evaluated the influence of keratoconus on stress at work, nor the influence of treatments of keratoconus on stress at work, including Quality of Life at work and on perception of work. Moreover, it has been shown that some pathologies had greater influence in some occupations, also depending on other characteristics of individuals such as age, sex or socio professional groups.

Therefore, we hypothesized that keratoconus 1) will influence stress at work including QoL at work and perception of work, 2) will have a greater influence in some occupations and depending on age, sex, or stage of keratoconus, 3) will induce stoppage of work and occupational reclassifications.

This is a descriptive, prospective, observational, monocentral study. For each patient with keratoconus and patient control, use of the auto questionnaire to carry out the study. we only assessed data from usual routine practice.

Stress at work is measured by Job Content Questionnaire of Karasek issued during consultations.

Study all workers the influence of keratoconus and its stage on:

* consequences of keratoconus in function of visual acuity, mode of correction and staging of the keratoconus.
* Psychological consequences: Quality of life at work, Perception of work (Karasek questionnaire), anxiety and depression (HAD scale)
* Professional consequences: stoppage of work and duration and occupational reclassifications
* Characteristics of the patient: age, sex, occupation.

Measures to reduce or avoid bias:

* Standardized, anonymous auto questionnaire
* A large workforce: high rate of participation is expected
* Inclusion of control group.

Eligibility Criteria:
Inclusion Criteria:

* patients with keratoconus all stages followed at the CHU Gabriel Montpied,
* patients constituting a representative control group of workers consulting in ophthalmology service of Clermont-Ferrand.

Exclusion Criteria:

* an other ophtalmological disease alters visual acuity.
* minors subjects
* inability to provide informed consent
Intermittent-pneumatic Compression in Inhalation-injury Children: Effects on Diaphragm Mobility and Pulmonary Function

inhalation injury is very common in infants, young, children. complications of this problems are low pulmonary functions and limited mobility of main inspiratory muscle.

inhalation injury patients (children, n = 40) will be included in intermittent pneumatic compression group (n = 20, this device, intermittent pneumatic compression, will be used a resistive inspiratory muscle training for diaphragm muscle and the 10-set training will be done five session per the week, for 12 weeks. besides this training, traditional physical therapy program will be handled). In other inhalation group, n =20, traditional physical therapy program will be handled only)

Eligibility Criteria:
Inclusion Criteria:

* inhalation injury

Exclusion Criteria:

* brain injury
* fractures of any body part
* cardiac or chest disorders
Endovascular Magnesium Sampling in Acute Stroke

This investigation will address the safety and feasibility of distal, intra-arterial sampling through endovascular access, in acute stroke patients. Levels of Magnesium will be measured in the region of infarct in patients who had been treated with intravenous Magnesium therapy following an acute stroke. This study attempts to address whether the traditional intravenous means of neuroprotectant administration achieves adequate concentration of the therapeutic agent in the area of diseased tissue.


Eligibility Criteria:
Inclusion Criteria:

1. Patient with acute cerebral ischemia due to ICA or MCA occlusion,
2. Patient already enrolled in the NIH FAST-MAG clinical trial,
3. Patient's clinical attending physician plans mechanical embolectomy procedure as part of routine clinical care.
4. Age 40-95 inclusive (age criteria for FAST-MAG Trial).

Exclusion Criteria:

1. Technical inability to navigate microcatheter to target clot.
2. Patient or surrogate unavailable for consent
The Randomized Double-blind Placebo-controlled Trial of Intralesional Botulinum Toxin A Injection for Recalcitrant Alopecia Totalis and Alopecia Universalis

The main purpose of this study is to determine the efficacy of intralesional botulinum toxin type A injection for recalcitrant alopecia totalis and alopecia universalis.

Treatments of recalcitrant alopecia totalis and universalis remains an challenge issue for medical practice.The application of diphenylcyclopropenone (DPCP) is still being an standard treatment for the condition, however, there are at least thirty percentage of patients recalcitrant to this treatment.

The complete etiology of this disease has yet to be clear.Nevertheless,recent studies have demonstrated the hypothesis of neurotransmitter involvements.

There is numerous evidence in support of an imbalance of transmitters, including substance P and Calcitonin gene-related peptide.

Botulinum toxin A injection has been used to treat a neuralgiform headache and diffused alopecia areata. Both headache and hair loss have been made much in improvement. This data may support the neurotransmitter imbalance theory.

The investigators have been informed about possible effects to the alopecia condition, therefore, this study is conducted to assess the efficacy of botulinum toxin A as the novel treatment for recalcitrant alopecia totalis and alopecia universalis.


Eligibility Criteria:
Inclusion Criteria:

1. All patients must be over 18 years old
2. All patients are diagnosed with alopecia totalis or alopecia universalis
3. The alopecia condition was not responded to any treatments

Exclusion Criteria:

1. Having an active inflammation on scalp area
2. Allergic to botulinum toxin A of human albumin
3. Has been diagnosed with neuromuscular disorders
4. Taking any medication that may interfere with botulinum toxin A action
5. Receiving any treatment for alopecia condition within 4 weeks
6. Pregnant , breastfeeding, plan to pregnant patients
Efficacy and Safety of SR1375 in Adult Patients With CAP

This is a phase 2 study to evaluate the efficacy and safety of SR1375 in hospitalized adult patients with CAP. Patients will receive SR1375 or placebo for 8 weeks. The study duration for each patient is up to 10 weeks.

This is a randomized, double-blind and placebo-controlled phase 2 study comparing SR1375 with placebo in adult patients with CAP. It consists of a screening period, a double-blind treatment period, and a post-treatment safety follow-up period. Baseline NIAID-OS 8-point scale score will be checked for eligibility. Around 240 eligible subjects will be recruited and randomized into four arms at 1:1:1:1 ratio to receive SR1375 0.3mg, SR1375 1mg, SR1375 3mg or placebo orally daily for 56 days. Subjects, investigators, all clinical study site staffs, and the Sponsor will remain blinded to treatment assignment during the study. Subjects will receive regular treatments as per his/her condition by investigator. After completion of double-blind treatment period, subjects will continue to complete the safety follow-up for 14 days.

Eligibility Criteria:
Key Inclusion Criteria:

* Age ≥ 18 years, male or female
* Diagnosis of CAP
* Baseline NIAID-OS 8-point scale score of 5 points and transcutaneous oxygen saturation ≤ 93% without oxygen inhalation or 6 points. (5 points refer to hospitalization with oxygen therapy; 6 points refer to hospitalization with high flow oxygen therapy or non-invasive mechanical ventilation. High oxygen flow refers to ≥ 4 L/min.)
* With ≥ 1 high risk factors including chronic obstructive pulmonary disease (COPD), pulmonary fibrosis, type 2 diabetes, chronic kidney disease, coronary heart disease, age ≥ 65 years, moderate obesity (body mass index\>32.5kg/m2), etc.
* Participants of women of childbearing potential(WOCBP) and male participants with WOCBP partners must agree to use one or more effective contraceptive methods during the treatment period and until 90 days after the last administration.

Key Exclusion Criteria:

* Have received or require invasive mechanical ventilation or ECMO within 24 hours.
* With septic shock requiring vasoactive drugs.
* Unable to swallow capsules due to consciousness disorders or other reasons.
* With active tuberculosis, severe asthma, hyperglycemia, hyperosmolality, ketoacidosis or diabetes foot.
* Have experienced unstable angina, acute myocardial infarction, or stroke within the past 3 months.
* Have taken glucocorticoids with an average daily dose \>40 mg methylprednisolone or equivalent dose within the past 3 days.
Comparative Effects of Dexmedetomidine and Ketofol for Sedation in Patients Undergoing Trans-esophageal Echocardiography

The purpose of the study is to compare dexmedetomidine and ketofol to find a suitable alternative for moderate sedation in out-patient diagnostic trans-esophageal echocardiography.

Sample size was estimated based on previous studies with sedation in equally invasive procedures that in 2 groups difference in time to achieve Ramsay sedation scale was 0.8min.(In group dexmedetomidine 12.4 \& group ketofol 13.2 with S.D of 0.8). The sample size came out to be 22 subjects per group at a power of 90 % \& confidence interval of 95 %. For possible dropouts, it was decided to include 10% extra subjects so finally it was decided to include 25 subjects per group. (Total sample size 50 subjects)

Normality of quantitative data will be checked by measures of Kolmogorov Smirnov tests of normality. If data is normally distributed Student t-test will be applied for comparison of 2 groups. Mann-Whitney U-test will be used for statistical analysis of skewed continuous variables or ordered categorical data. Proportions will be compared using Chi square or Fisher's exact test whichever is applicable. Wilcoxon Signed rank test will be used for skewed data or for scores (time related variables). . For comparison (time related variables) of Hemodynamics Repeated Measure ANOVA will be applied. All statistical tests will be two-sided and will be performed at a significance level of α=0.05. Analysis will be conducted using SPSS for Windows

Eligibility Criteria:
Inclusion Criteria:

* Patients with Atrial septal defect/Valvular Heart disease (MS/MR/AS/AR)

Exclusion Criteria:

* Atrial fibrillation with fast ventricular rate
* Congestive cardiac failure
* BMI \> 30
* Perforated viscus/active GI bleed
* Esophageal stricture/tumor/laceration
* H/o radiation to neck \& mediastinum
* H/o GI surgery or H/o dysphagia
* Restriction of neck mobility
* Active esophagitis/peptic ulcer disease
* Symptomatic bradycardia
* Seizure disorder
* Coagulopathy/thrombocytopenia