cyrilzakka/clinical-trials huggingface dataset:
ML-004 in Adolescents and Adults with Autism Spectrum Disorders (ASD)

ML-004-002 is a multi-center, randomized, double-blind, parallel-group, placebo-controlled study that will enroll approximately 150 adolescent and adult subjects with ASD. The primary objective is to evaluate the efficacy of ML-004 compared with placebo in the improvement of social communication deficits in subjects with ASD.


Eligibility Criteria:
Inclusion Criteria:

* Age 12 to 45 at screening
* Has a designated care/study partner who can reliably report on symptoms
* Has a diagnosis of Autism Spectrum Disorder (ASD)
* Has a body mass index (BMI) 18 through 34 kg/m², inclusive
* Full scale IQ (or equivalent) ≥55 score, with adequate verbal fluency, as determined by the Principal Investigator.
* Psychoactive medications and adjunctive therapies are stable for 4 weeks prior to screening
* Must be able to swallow study medication

Exclusion Criteria:

* Has Rett syndrome or Child Disintegrative Disorder
* Has participated in any other study and received any other investigational medication (other than COVID-19 vaccination) or device within 60 days prior to screening
* History of epilepsy without current adequate control, or any seizure in the 6 months preceding screening
* History of suicidal ideation or behavior in the past 12 months, or a positive response to C-SSRS questions 4 and/or 5
* Systolic blood pressure ≥140 mmHg (if adult) or \>135 mmHg (if adolescent), or diastolic blood pressure ≥90 (if adult) or \>85 mmHg (if adolescent), or a clinical history of uncontrolled or severe hypertension
* If female, is pregnant or lactating
Micropulse Laser Trabeculoplasty (MLT) Versus Selective Laser Trabeculoplasty (SLT) for Treatment of Open Angle Glaucoma

The purpose of this study is to evaluate the effectiveness of a new laser (called Micropulse Laser Trabeculoplasty or MLT) in the treatment of glaucoma compared to the conventional laser presently used which is called selective laser trabeculoplasty or SLT. Both lasers (SLT and MLT) are used as standard of care in the treatment of open angle glaucoma.

Glaucoma is the 2nd leading cause of blindness worldwide and affects over 2.5 million Americans over the age of 40. It is thought that elevated intraocular pressure causes damage to the optic nerve fibers which leads to silent vision loss in glaucoma. Therefore, the primary approach to managing this disease process is through intraocular pressure reduction with a) topical drops that decrease intraocular fluid production or increase fluid outflow, b) laser therapy to the outflow structures in the eye (trabecular meshwork) to increase fluid egression, c) or incisional surgery with or without placement of setons to create a new pathway for fluid outflow. When medical therapy has been maximized or patients do not tolerate topical therapy, laser trabeculoplasty is common applied to achieve further intraocular pressure reduction. There are two types of laser therapies: argon laser trabeculoplasty (ALT) and selective laser trabeculoplasty (SLT). The former involves applying laser to create outflow pathways in the trabecular meshwork (TM) and induces thermal damage to the TM. The latter selectively applies energy which induces inflammatory restructuring of the TM without creating a burn. Studies have shown comparable results between the two treatment modalities with SLT offering the advantage of repeatable treatment. Studies have also shown laser trabeculoplasty to be comparable to the effect of topical drops in intraocular pressure reduction. Side effects for both types of laser trabeculoplasty include post procedure intraocular pressure elevation and intraocular inflammation which is treated with topical drops after the procedure.

This study aims to evaluate the effectiveness of micropulse laser trabeculoplasty in intraocular pressure reduction in patients with open angle glaucoma as compared to conventional selective laser trabeculoplasty. Secondary aims would be to determine whether its reduction is comparable to that of topical intraocular pressure lowering drops, length of therapeutic intraocular pressure reduction, and incidence of side effects commonly encountered with traditional laser trabeculoplasty including intraocular inflammation and intraocular pressure spikes.

Eligibility Criteria:
Inclusion Criteria:

* Patients of any ange age
* Diagnosis of open angle glaucoma who have not had recent changes in their medication regimen.

Exclusion Criteria:

* Patients with active neovascularization of the angle, angle closure glaucoma, angle recession, or anterior uveitis
Patient Characteristics, Associated Factors, and Clinical Outcomes of Prescribing Encorafenib and Binimetenib Versus Dabrafenib and Trametinib Among BRAF v600 Mutated Metastatic Melanoma Patients

This was a retrospective real-world evidence cohort study. The study was conducted using the NOBLE (Novartis Braf+ meLanoma patients ObsErvational) dataset, with a study period from 01 January 2011 to 31 May 2020. All included patients were ≥18 years of age and were required to have a diagnosis of unresectable stage III or IV melanoma (ICD-9 172.x \& ICD-10 C43 or D03x), treatment with dabrafenib and trametinib (dab/tram) or encorafenib and binimetenib (enco/bini) on or after 01 June 2018, and evidence of a BRAF-positive result prior to or up to 30 days after therapy initiation.

No quota of centers was established a priori. Given the retrospective nature of this study, all patients who met the inclusion/exclusion criteria from the NOBLE dataset were included.


Eligibility Criteria:
Inclusion criteria

* Diagnosis of melanoma (ICD-9 172.x \& ICD-10 C43 or D03x)
* Pathologic stage III (unresectable) or IV at initial diagnosis on or after 01 January 2011
* 1L treatment with enco/bini or dab/tram on or after 01 June 2018
* Evidence of a BRAF test
* Evidence of a BRAF-positive result prior to or up to 30 days after 1L therapy initiation
* At least 18 years of age at the time of initiation of 1L treatment Exclusion criteria
* Documented receipt of a clinical trial treatment for cancer at any time on or after September 2015
* Diagnosis of a second primary cancer or secondary cancer following initiation of 1L metastatic melanoma (MM) treatment
Magic Shave Powder Gold's Affects on the Occurrence of Pseudofolliculitis Barbae

Comparing the amount of papules, macules, pustules, and irritation caused by pseudofolluculitis barbae in subjects using depilatory cream versus traditional shaving methods.

Comparing an experimental group that will remove facial hair with magic shave powder gold, and a control group that will continue using traditional shaving methods. Both the subject and a physician will make observations to determine the efficacy of depilatory creams in reducing pseudofolliculits barbae.

Eligibility Criteria:
Inclusion Criteria:

* Male
* PFB patient

Exclusion Criteria:

* Failed sensitivity testing
Prognostic Value of Biomarkers in Polyneuropathy.

Biomarkers for prognosis of patients with polyneuropathy.

AIM: To investigate biomarkers' use as a prognostic tool in polyneuropathy patients.

STUDY DESIGN: Prospective cohort study of patients with polyneuropathy. METHODS: 200 patients with polyneuropathy will be examined with physical tests, medical examination, questionnaires, and blood biomarkers at baseline and at 1-year follow-up, and 2-year follow-up.

ANALYSIS: The investigators will calculate the odds of disease progression after 2 years depending on biomarkers levels at baseline using multiple logistic regression with sex and age adjustment. Diagnostic performance of the physical tests and biomarkers for prediction of disease progression will be assessed by Receiver Operating Characteristic Curve analysis with the area under the curve.

Eligibility Criteria:
Inclusion Criteria:

* Minimum 18 years old.
* Diagnosed with polyneuropathy, confirmed by nerve conduction study.
* Can read and understand Danish.

Exclusion Criteria:

* Inability to perform physical tests due to comorbidity not associated to the patient's polyneuropathy.
Review of Palliative Radiotherapy in the Management of Advanced Head and Neck Cancer

To describe the charactersitics of patients with advanced head and neck cancer treated with palliative intent and determine outcome in terms of symptom control and toxicity


Eligibility Criteria:
Inclusion Criteria:

* squamous cell carcinoma of the head and neck, primary treatment given with palliative intent

Exclusion Criteria:

* radical treatment, palliative treatment following local recurrence, adenocarcinoma, salivary gland carcinoma or melanoma
Evaluation of a Male-focused Intervention to Prevent Intimate Partner Violence in a Conflict-affected Setting

Cluster randomized controlled trial to evaluate a male-focused primary prevention programme which used a men's only group discussion format to prevent intimate partner violence against women \& girls through fostering knowledge and behaviour changes by: (1) increasing men's knowledge on the impact of violence against women; (2) promoting gender equitable beliefs/behaviours within relationships; and (3) developing anger management techniques.


Eligibility Criteria:
Inclusion Criteria:

* 15+ years old
* males: participant in group intervention or selected as control
* females: female intimate partner of males in intervention or selected as control
* capable of completing face-to-face interview independently and without causing undue psychological distress

Exclusion Criteria:

* lack of informed consent
Clinical Trial of Rasagiline in Levodopa-Treated Parkinson's Disease Patients With Motor Fluctuations

The objective of this study is to evaluate the efficacy, tolerability, and safety of rasagiline compared to placebo in PD patients with motor fluctuations on levodopa therapy.

Levodopa has been the mainstay therapy for PD for decades, and it is considered to be one of the most effective medications for relief of the symptoms of PD. However, within few months to few years the majority of levodopa-treated patients notice a decline in the duration of benefit of each dose and develop motor-complications. A major problem is the appearance of fluctuations in mobility, cycles of ON and OFF periods. The administration of rasagiline, a MAO-B inhibitor, can slow the elimination of the endogenous dopamine supplies or the dopamine produced from the exogenous levodopa therapy and may therefore improve ON-OFF fluctuations.

The objective of this study is to evaluate the efficacy, tolerability, and safety of rasagiline compared to placebo in PD patients with motor fluctuations on levodopa therapy.

Eligibility Criteria:
Inclusion Criteria:

* Patients with idiopathic PD
* Patients receiving at least 300 mg daily doses of levodopa and not less than 8 daily doses of levodopa with the stable dose
* Patient with a Modified Hoehn and Yahr stage between 2 to 4 in the OFF state
* Patient with motor fluctuations averaging at least 2 hour daily in the OFF state
* Patients who have demonstrated the ability to keep accurate 24-hour diaries

Exclusion Criteria:

* Patients with Parkinsonian syndrome induced by medicine, metabolic disease, Encephalitis and central nervous system degenerative diseases or Disease of basal ganglia
* Patients with severe cognitive impairment judged by a Mini Mental State Examination
* Patients with a clinically significant psychiatric illness
* Patients with Hamilton Depression Rating Scale (HAMD): total score ≤10
* Patients with a clinically significant or unstable medical or surgical condition which would preclude safe and complete study participation
* Patients with a clinically significant or unstable vascular disease
* Patients with severe disabling dyskinesias Other inclusion and exclusion criteria may apply
Phenylephrine Versus Norepinephrine for Septic Shock in Critically Ill Patients

Septic shock is a condition that is marked by severe infection causing hypotension requiring vasopressors to maintain adequate perfusion to vital organs. The Surviving Sepsis campaign, an international organization formed for the purpose of guiding the management of sepsis and septic shock, currently recommends norepinephrine as the first-choice vasopressor for septic shock. Phenylephrine, a vasopressor FDA-approved for use in septic shock, is recommended as an alternative vasopressor when septic shock is complicated by tachyarrhythmia to mitigate cardiac complications. This recommendation is based solely on experience with no scientific evidence to support this recommendation.

The investigators will conduct an open-label randomized controlled trial (RCT) directly comparing phenylephrine and norepinephrine, two FDA-approved vasopressors that are both used in clinical practice for the management of septic shock. The investigators will perform this study with a population of patients that have septic shock to complete the following aims:

Aim 1: Determine the incidence of tachyarrhythmias.

Aim 2: Determine which vasopressor, phenylephrine or norepinephrine, is associated with a lower heart rate.

Aim 3: Determine which vasopressor, phenylephrine or norepinephrine, is associated with a higher incidence of new tachyarrhythmias.

Aim 4: Determine which vasopressor, phenylephrine or norepinephrine, is associated with less time in tachyarrhythmia.

Aim 5: Determine which vasopressor, phenylephrine or norepinephrine, is associated with fewer complications, including cardiac complications.

The investigators hypothesize that in this setting, phenylephrine will improve the management of septic shock when used as a "first choice" vasopressor by:

1. Decreasing the mean heart rate
2. Decreasing the incidence of new tachyarrhythmias
3. Decreasing the amount of time spent in tachyarrhythmia for patients who develop new onset and recurrent tachyarrhythmias
4. Decreasing the number of cardiac complications


Eligibility Criteria:
Inclusion Criteria:

* Adults 18 years of age or greater
* Intention to treat with vasopressor for diagnosis of septic shock
* Exclusion criteria not met

Exclusion Criteria:

* Emergent indication for surgery
* Patient possesses a terminal condition for which patient or medical decision maker has decided to de-escalate medical care (patients with Do Not Resuscitate order but for whom standard care is continued will not be excluded)
* Known allergy to phenylephrine or norepinephrine
* Treated with vasopressor \>12 hours for current episode of shock
* Preference of specific vasopressor agent by patient's provider
* Pregnancy
Clinical Orthopaedic Data Bank (Acute and Chronic)

Data involving orthopaedic conditions and rehabilitation aspects of musculoskeletal and neuromuscular disorders will be collected and stored as part of the normal clinical care of patients seen in the University of Florida (UF) and Shands Orthopaedics and Sports Medicine Institute.

All patients seen the Orthopaedic clinic will be informed of the data collection and asked to participate. If the patient is agreeable to participation, informed consent will then be obtained.

Eligibility Criteria:
Inclusion Criteria:

* All patients seen in the UF\&Shands Orthopaedics and Sports Medicine Institute will be asked to sign an informed consent.

Exclusion Criteria:

* No exclusions, all patients interested in participation will be asked to sign an informed consent.
Application of Capnography Monitoring on the General Care Nursing Unit

The aim of this study is to increase the detection of undiagnosed obstructive sleep apnea (OSA) and secondly to increase the sensitivity for detection of respiratory depression (\< 6 breaths per minute) in post operative patients on the general care nursing unit.

Measures: This is an IRB approved prospective trial beginning with randomization in the post anesthesia care unit (PACU) and continuing for thirty six hours post orthopedic surgical procedure. The patients are randomized into a capnography or standard of care group and the percentage of newly identified OSA patients were measured in each group using the criteria set forth by 2006 American Society of Anesthesiologist practice guideline (Anesthesiology 2006; 104:1081-93).

Background/Changes: Hospital complications are three times higher in patients with obstructive sleep apnea and the majority of these complications are related to opioid induced respiratory depression (Mayo Clin Proc Sept 2001:897-905). American Society of Anesthesiologist 2006 practice guideline for perioperative management of patients with obstructive sleep apnea (Anesthesiology 2006; 104:1081-93) lists the criteria for identifying undiagnosed obstructive sleep apnea. One of the risk factors in the guideline lists apnea (pauses in breathing). Capnography measures apnea episodes and continuously monitors respiration rate.

As previously described, five percent of the general population has obstructive sleep apnea (OSA) and the prevalence among patients requiring surgery is 9% (NEJM 1993; 328:1230-1235). Between 50-80% of OSA individuals are undiagnosed when presenting for surgery.

Eligibility Criteria:
Inclusion Criteria:

* Orthopedic surgical procedure
* Respiration rate \< 10 breaths per minute requiring supplement oxygen
* One of the following:

  * body mass index \>30
  * history of snoring
  * basal rate of opioid, and
  * one event of RR \<10 in the post anesthesia care unit.

Exclusion Criteria:

* COPD
* \< 18 y/o
* A diagnosis of obstructive sleep apnea.
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple s.c Doses HS-20004 in Healthy Chinese Volunteers

This trial is conducted in China. The aim of this trial is to assess the safety and tolerability for Multiple s.c injection of HS-20004 in healthy Chinese subjects


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) between 19 and 28 kg/m\^2, inclusive, and a total body weight of at least 50 kg;

Exclusion Criteria:

* Clinically relevant abnormalities of physical examination, laboratory values, vital signs or ECG findings at the screening, as judged by the Investigator;
* Have any other medical abnormality (such as cardiovascular, hepatic, renal, gastrointestinal, immunologic, hematological, hormonal, metabolic, neoplasmatic or mental disease), which in the opinion of the investigator, might affect the absorption, distribution, metabolism, and excretion of the study drug, or prevent the patient from following and completing the protocol;
* Family history of diabetes, thyroid cancer, submandibular gland cancer, or history of pancreatitis, cholelithiasis, drug allergy, serious unconscious hypoglycemia or positive of anxious chronic viral hepatitis B, HIV antibody;
* History of drug or alcohol abuse within 6 months before randomization;
* Use of GLP-1 analogues, DPP-IV enzyme inhibitors, as well as other hypoglycemic drugs within 3 months before randomization;
* Use of any prescription drugs and Chinese herbal medicines within 4 weeks before randomization;
* Use of non prescription drugs and food supplements (vitamins, etc.) within 2 weeks before randomization;
* Participated any drug clinical trials within 3 months, or participated 3 or more than 3 drug clinical trials within 1 year, or had blood donation/loss \>400mL within 3 months before randomization;
* Female subject of childbearing potential who does not use an acceptable method of birth control, is pregnant or planning a pregnancy, or breastfeeding, or male subject who does not use an acceptable method of birth control, within six months before randomization;
* Subject who cannot refrain from smoking, eating and/or drinking containing xanthine/caffeine, or strenuous exercise, or others that affect drug absorption, distribution, metabolism and excretion within 2 days before the study drug administration; Subject who is unsuitable for inclusion in the study in the opinion of the investigator;
Olfactory Training on Smell Dysfunction Patients in HK

* Causes of olfactory dysfunction can be classified into conductive and sensorineural causes.
* Conductive causes are mainly due to structural nasal problem, which can be treated by nasal surgery
* Sensorineural causes included post-infection, post-head injury, post Head and Neck irradiation and other central nervous system diseases.
* Olfactory Training is well established treatment for sensorineural olfactory dysfunction in foreign countries.
* Olfactory Training by neurological chemosensory stimulation using aromatic substances delivered via electronic portable aromatic rehabilitation (EPAR) diffuser was proved to be effective treatment in COVID-19 related olfactory dysfunction in recent Hong Kong study.
* However, there is a lack of local study on the effect of Olfactory Training in other non-COVID-19 sensorineural causes of olfactory dysfunction in Hong Kong population.

Design Prospective double-blinded randomized control trial.

Study Period 1/7/2022 - 30/6/2024 for case recruitment.

Suitable patient will be recruited. Informed consent will be signed. Objective smell assessment will be done using the University of Pennsylvania Smell Identification Test (UPSIT) and Butanol Threshold Test (BTT). Subjective quality of life score will be obtained by Sino-Nasal Outcome Test (SNOT-22). Subjective smell and taste assessment will be assessed by Visual Analogue Scale (VAS). Patient will be randomized into treatment group and control group using computer generated list by an independent nursing staff. Doctors and the patients will be blinded during the study.

Eligibility Criteria:
Inclusion Criteria:

* Olfactory dysfunction \> 6 months and \< 5 years

Exclusion Criteria:

* History of significant head injury (fracture, ICH)
* History of brain surgery
* History of nasal surgery
* Active nasal disease
* Active neurological disease
* Poor premorbid status/ non-communicable patients
* Mentally incompetent patients
* \<18 years' old
* Pregnancy
* Hypersensitivity to the aromatic substance.
Spine Trauma in the Elderly

Our study aims at investigating short and long-term outcomes following surgery for subaxial spine injuries in the elderly (octogenarian) population.


Eligibility Criteria:
Inclusion Criteria:

* All patients surgically treated for subaxial spine injuries between 2006 and 2018

Exclusion Criteria:

* Missing records
Tobacco-Related Disease Prevention Among Korean Americans

The study evaluates the effectiveness of an internet-based smoking cessation program for Korean Americans.

Smoking is prevalent among Korean American men. Quitting is Winning, an internet-based, cognitive-behavioral smoking cessation program, was developed using community-based participatory research principles.

A randomized controlled trial was used to evaluate whether participants were more likely to complete the program and quit smoking at 6-month follow-up with additional reinforcement including financial incentives for program completion and interim surveys.

Eligibility Criteria:
Inclusion Criteria:

* self-identified Korean American ethnicity
* age 18 years or older
* daily smoker (i.e., smoked at least one cigarette per day during the previous seven days)
* current U.S. resident
* valid email address
* regular internet access.

Exclusion Criteria: None