cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of OMA102 in the Treatment of Female Pattern Hair Loss

The goal of this clinical trial is to evaluate the efficacy and safety of OMA102 1 mg and OMA102 2 mg versus placebo in the treatment of female pattern hair loss.


Eligibility Criteria:
Inclusion Criteria:

* Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms;
* Age greater than 18 and equal or under 50 years;
* Confirmed diagnosis of female pattern hair loss, grade II to IV in Sinclair Scale;
* Participants that are disposed to maintain the same hair color, style, approximate hair length throughout the Clinical Study.

Exclusion Criteria:

* Any clinical or physical finding interpreted by the investigator as a risk to subject participation in the Clinical Study
* History of alcohol or illicit drugs abuse in the last year;
* Pregnant or breastfeeding women, who are planning to become pregnant or participants who have childbearing potential and are not using any reliable contraceptive method;
* Allergy or sensibility to any knowing components of the formula;
* Diagnosis of arterial hypertension;
* History of vasovagal syncope;
* Baseline systolic blood pressure lower than 90 mmHg and/or diastolic lower than 60 mmHg;
* Diagnosis of orthostatic hypotension (reduction of systolic blood pressure equal or superior to 20 mmHg and/or diastolic equal or superior to 10 mmHg after 3 minutes in orthostatic position);
* Body mass index (BMI) \> 30 kg/m²;
* Subjects that initiated any kind of continue use medication, including contraceptives with systemic effect, until 3 months previously the inclusion in the Clinical Study;
* History of cardiovascular, liver and renal diseases;
* History of hypothyroidism, hyperthyroidism or pheochromocytoma;
* Signs or symptoms of cardiopathy or angina;
* History of edema from any etiology;
* Participants who are using tricycle antidepressants, benzodiazepines, antipsychotics, anticholinergics, sulfonamide derivatives, beta-blockers, sympathomimetics, arginine, glucocorticoid or monoamine oxidase inhibitors;
* Use of inhibitor of 5-alpha reductase or androgenic blockers in the last 12 months;
* Dermatologic diseases of the scalp, except mild seborrheic dermatitis or diagnosis of any kind of alopecia other than female pattern hair loss;
* History of surgical treatment for hair loss or presence of shaved scalp;
* Scalp microinfusion, microneedling or intradermotherapy in the last 3 years;
* Vaginal or cesarean deliveries 6 months before the inclusion in the study;
* Drastic modification of habitual diet, as food restrictions or hyperselectivity;
* Current cancer or history of cancer in the last 5 years;
* Participation in others research protocols in the last 12 months, unless the investigator judges that there may be a direct benefit to the participant.
Cognitive Behavioral Suicide Prevention for Psychosis: Aim 1

The investigators are modifying and testing the preliminary effectiveness and implementation of a Cognitive Behavioral Suicide Prevention for psychosis (CBSPp) intervention. In this phase of the study, CBSPp will be tested in an initial open trial (n = 10) to examine its feasibility and acceptability. Investigators will recruit clients receiving services at a community mental health setting who have a schizophrenia spectrum disorder and recent suicidal thoughts and behaviors to receive the behavioral intervention for 10-weeks. Providers will be recruited and trained to deliver the intervention. Both clients and providers will be assessed at baseline to test our approach to measurement prior to the Aim 2 RCT (registered separately). Clients will be assessed at three additional timepoints (middle of treatment, end of treatment, and 2 months after treatment ends.


Eligibility Criteria:
Inclusion Criteria:

* Schizophrenia Spectrum Disorder
* Suicide ideation and/or attempt within 3 months of screening
* Ability to speak and read in English
* 18 to 65 years of age

Exclusion Criteria:

* Requiring emergency care (e.g. imminent plan to harm self) as determined by trained research staff administering the Columbia-Suicide Severity Rating Scale (C-SSRS)
* Inappropriate for behavioral treatment according to own judgment in consultation with a treating clinician CMH
* Impaired capacity (cognitive capacity)
Dispensing Evaluation of Printed Etafilcon A With Polyvinylpyrrolidone (PVP)

The purpose of this study is to evaluate the lens fit (mechanical and cosmetic lens fit) of the printed etafilcon A with polyvinylpyrrolidone (PVP).


Eligibility Criteria:
Inclusion Criteria:

1. The subject must be at least 18 years of age and less than 40 years of age.
2. The subject must be a light eye Caucasian female habitual soft contact lens wearer.
3. The subject must be concept acceptors for cosmetic and/or limbal ring lenses. A concept screening questionnaire will be used and top 3 box (in 5-point scale) is eligible.
4. The subject must have no known ocular or systemic allergies that might interfere with contact lens wear.
5. The subject must have no known systemic disease, or need for medication, which might interfere with contact lens wear.
6. The subject's optimal vertexed spherical equivalent distance correction must be between -1.00 and - 5.00D.
7. Any cylinder power must be ≤ -0.75D.
8. The subject must have visual acuity best correctable to 20/25+3 or better for each eye.
9. The subject must have normal eyes (no ocular medications or ocular infection of any type).
10. The subject must read and sign the Statement of Informed Consent.
11. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.

Exclusion Criteria:

1. Ocular or systemic allergies or disease which might interfere with contact lens wear.
2. Systemic disease or use of medication which might interfere with contact lens wear.
3. Clinically significant (grade 3 or worse) corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear.
4. Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear.
5. Any ocular infection.
6. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
7. Any color deficiencies - to the best of the subject's knowledge.
8. Pregnancy or lactation.
9. Diabetes.
10. Infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. HIV).
11. Habitual contact lens type is toric, multifocal, or is worn as extended wear.
Evaluation of the Safety and Biologic Effects of an Eicosapentaenoic (EPA)-Enriched Oil

The goal is to test the safety and efficacy of an EPA-enriched oil made by DuPont. DuPont wishes to corroborate the safety of its novel oil rich in EPA in humans prior to placing such a dietary supplement on the market. The goal of this study is to test this oil at doses of 600 mg and 1800 mg of EPA/day as compared to olive oil placebo and a comparator oil providing 600 mg of DHA/day over a 6 wk period. In a parallel arm study design, 120 healthy adults will be randomized to one of four groups (30 in each group) and studied in both the fasting and post-prandial state.

The safety profile of omega-3 fatty acids is considered to be excellent, and has been recognized as safe (GRAS) by the US Food and Drug Administration when EPA and DHA (docosahexanoic acid) are given together at a dose of 3 grams/day or less. Safety will be monitored by assessing for adverse reactions, measuring vital signs and a variety of laboratory tests including a complete metabolic profile and complete blood count. Efficacy will be assessed by measuring changes in fatty acid profile and or fatty acid ratios.

The goal of this study is to test this EPA oil at doses of 600 mg and 1800 mg of EPA/day as compared to olive oil placebo and a comparator oil providing 600 mg of DHA/day over a 6 wk period. In a parallel arm study design, 120 healthy adults will be randomized to one of four groups (30 in each group) and studied in both the fasting and post-prandial state.

Eligibility Criteria:
Inclusion Criteria:

* healthy male or surgically sterile females between ages 21-70.
* BMI of 20-35.

Exclusion Criteria:

* competitive exerciser.
* current smokers.
* those already taking dietary supplements (EPA, DHA, flax seed oil, fish oil, cod liver oil, weight control products, or high doses of vitamin C (\> 500 mg/day) or vitamin E (\> 400 units/day).
* those consuming more than 3 oily fish species/week.
* those consuming \> 2 drinks/day.
* those with a history of a bleeding disorder, or history of significant cardiac, renal, hepatic, gastro-intestinal, pulmonary, neoplastic, biliary or endocrine disorders such as uncontrolled thyroid disease, or uncontrolled hypertension or diabetes.
* those taking medications affecting serum lipids, body weight, or blood clotting.
Evaluation of a Resident Curriculum in Firearm Injury Prevention

The purpose of this project is to evaluate the efficacy of a web-based curriculum designed to teach pediatric practitioners how to provide injury prevention anticipatory guidance, emphasizing firearm injury prevention in a clinic setting. Data will be collected regarding the curriculum's effectiveness using a web-based questionnaire which will be administered to pediatric residents prior to, immediately post, and six months following completion of the curriculum. Pre- and post-test questionnaires will be compared. Residents will also be asked to evaluate the curriculum by completing a survey. We hypothesize that the curriculum will improve residents' knowledge, attitudes and beliefs, and self-efficacy regarding firearm injury prevention anticipatory guidance.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric resident at Children's Memorial Hospital

Exclusion Criteria:

* None
A Phase 2 Study of ASP1585 in Chronic Kidney Disease Patients With Hyperphosphatemia on Hemodialysis

To evaluate the superiority to placebo, dose-responsibility and safety.

This is a multi-center, randomized, double blind placebo-controlled and open label sevelamer hydrochloride-controlled, dose-ranging study in CKD patients with hyperphosphatemia on hemodialysis. Patients will be randomly allocated to one of the five treatment groups (ASP1585: 3 dose, placebo, Sevelamer hydrochloride) and advance to the 4-week treatment period.

Eligibility Criteria:
Inclusion Criteria:

* Stable CKD patients who are currently on hemodialysis three times a week for at least 12 weeks prior to the acquisition of informed consent
* Patients on stable dose(s) of phosphate binder(s) for at least 28 days prior to the acquisition of informed consent.
* Patients on stable dose(s) of Vitamin D or calcitonin agent for at least 28 days prior to the acquisition of informed consent, in case patients are treated by those agents

Exclusion Criteria:

* History of major gastrointestinal surgery, or swallowing disorders, bowel obstruction, hemorrhagic gastrointestinal lesion
* Continuous severe constipation/diarrhea.
* History of parathyroid intervention \[parathyroidectomy（PTx），percutaneous ethanol injection therapy（PEIT）etc.\] within 1 year of the acquisition of informed consent
* Diet restriction such as fasting and/or excessive dieting
* Uncontrolled hypertension
Improving Cognition in People With Progressive Multiple Sclerosis Using Aerobic Exercise and Cognitive Rehabilitation

Given that up to 70% of people with secondary progressive MS are cognitively impaired, the search for effective treatments is considered a priority by people living with the disease. This proposal will address the effectiveness of cognitive rehabilitation (CR) and exercise, either alone, or in combination in this regard. A team of MS researchers has been assembled from the USA, Canada, the United Kingdom, Italy, Denmark, Germany and Belgium for this. A total of 360 people with progressive MS will make up the sample. Brain MRIs will be undertaken in a third of the sample before and after the 12 weeks of treatment to document the functional changes that are expected to occur with symptom improvement.

Aim: The broad aim of this proposal is to evaluate a multidisciplinary and multi-modal approach to rehabilitation in people with progressive MS. Cognitive rehabilitation and aerobic exercise will be evaluated individually and in combinations to address cognitive dysfunction as the primary outcome variable.

Over 20 years have passed since the introduction of the first disease modifying treatment, interferon beta-1betaseron (b), for multiple sclerosis (MS).Since then 13 treatments have been approved and made it onto the market. All are for relapsing-remitting disease (RRMS), apart from mitoxantrone which is limited to progressive disease with relapses, Interferon-beta-1b, which is for secondary progressive disease (SPMS), but does not delay disability progression and Ocrelizumab for primary progressive MS only. Thus, for a sizeable proportion of people with MS there is no therapeutic option to slow progression. This raises the question, how are patients with primary and secondary progressive MS (PPMS and SPMS) to be helped? While research is underway to find a medication that holds promise of halting further deterioration in a disease that has already entered a progressive stage, patients and their clinicians are left with basically symptomatic treatments.

Hypothesis: The investigators hypothesize that CR and aerobic exercise are effective treatments for cognitive impairment (processing speed deficits) in people with progressive MS. In particular a combination of these two treatment given twice weekly over 12 weeks is more effective than each individual treatment given alone or as sham. The investigators further hypothesize that improvements in processing speed will be matched on functional MRI (fMRI) by enhanced neural activity in networks associated with information processing speed.

Eligibility Criteria:
Inclusion Criteria:

* Have a confirmed diagnosis of progressive Multiple Sclerosis
* Visual Acuity of 20/70
* Language comprehension, to ensure subjects have the ability to understand instructions

Exclusion Criteria:

* Wheelchair dependent (EDSS \> 7.0)
* History of central nervous system disease other than progressive MS
* Steroids use within the past 3 months
* Regular aerobic training (eg. bi-cycling, running, swimming or rowing)
* Unwilling to travel to study sites for rehabilitation 2 times a week for 3 months
Single-retainer Lithium Di-silicate Versus Zirconia Resin Bonded Bridge for Replacement of an Anterior Missing Tooth.

First, Participants in this study will be recruit according to inclusion criteria. Proper examination for the participants (clinically and radiographically). Preparation for abutment tooth for Resin bonded fixed partial denture. Checking and verification for the restoration (trying). Clinical assessment and survival evaluation of the final restoration on delivery and on follow-up every 12 weeks for 12 months.

Examination and diagnosis: Selection and examination of the patients according to inclusion and exclusion criteria. Diagnosis of the patient's chief complaint and teeth that will be involved in this study will be done.

Primary alginate impressions for diagnosis on primary casts and for mounting. The patients will be asked to maintain good oral hygiene measures by using tooth brush twice daily.

Taking a professional pre-operative photo.

Tooth preparation procedure:

1. Preparation of abutment tooth for Resin bonded fixed partial denture according to specific standardized design for both types of final restorations.
2. After tooth preparation, the final impression will be taken for each participant using the intraoral scanner.
3. Fabrication of temporary restoration using composite resin temporary material and cemented using Zinc Oxide eugenol free temporary cement.

Fabrication of final restoration:

Lithium Di-silicate or Zirconia Resin bonded fixed partial denture will be fabricated according to group.

Clinical assessment and survival evaluation of the final restoration on delivery and on follow-up every 12 weeks for 12 months following outcome measures.

Eligibility Criteria:
Inclusion Criteria:

* All subjects are required to be:

  1. From 15-50 years old, to be able to read and sign the informed consent document.
  2. Have no active periodontal or pulpal diseases.
  3. Psychologically and physically able to withstand conventional dental procedures
  4. Maintenance of good oral hygiene.
  5. Able to return for follow-up examinations and evaluation
  6. Patients have missing upper incisor tooth.

Exclusion Criteria:

1. Patient less than 15 or more than 50 years old
2. Patient with active resistant periodontal diseases
3. Patients with poor oral hygiene and uncooperative patients
4. Pregnant women
5. Patients in the growth stage with partially erupted teeth
6. Psychiatric problems or unrealistic expectations
7. Lack of opposing dentition in the area of interest
8. More than one missing tooth in the area of interest
Oral Omadacycline vs. Oral Linezolid for the Treatment of ABSSSI

The purpose of this study is to evaluate the safety and efficacy of omadacycline as compared to linezolid in the treatment of adults with acute bacterial skin and skin structure infections.


Eligibility Criteria:
Inclusion Criteria:

* Patients, ages 18 years or older who have signed the informed consent
* Has a qualifying skin and skin structure infection
* Female patients must not be pregnant at the time of enrollment
* Must agree to a reliable method of birth control during the study and for 30 days following the last dose of study drug

Exclusion Criteria:

* Infections where the outcome is strongly influenced by factors other than protocol-defined treatments and procedures, or that require antibacterial treatment for greater than 14 days
* Evidence of significant immunological disease
* Severe renal disease or requirement for dialysis
* Evidence of septic shock
* Has a history of hypersensitivity or allergic reaction to any tetracycline or to linezolid
* Has received an investigational drug within the past 30 days
* Women who are pregnant or nursing
Oran Park Mask External Clinical Study (3) Marketing Claims Study

The goal of this prospective, randomized, open label, cross over study to assess the seal, comfort, usability, and performance of the prototype Oran Park mask system (referred to as Mask A in this study protocol) in the home environment. Comparisons will be made against Fisher \& Paykel's Evora Full mask system (referred to as Mask B in this study protocol, an FDA cleared benchmark mask) and the participant's own mask.

Patients diagnosed with Obstructive Sleep Apnea and are current CPAP users on a tube down full-face mask system will be recruited to the study to evaluate the Oran Park mask system and the Evora Full mask system for up to 7 nights each, in the home environment, whilst using their own CPAP device.

The overall purpose is to evaluate the performance of the prototype Oran Park mask system compared to an FDA cleared benchmark mask (Evora Full) in relation to seal, comfort, usability, ease of use, preference, AHI, and objective therapy data.


Eligibility Criteria:
Inclusion Criteria:

* Participants willing to give written informed consent
* Participants who can read and comprehend English
* Participants who ≥ 18 years of age
* Participants being treated for OSA for ≥ 12 months
* Participants who have met CMS compliance for CPAP therapy over the last 3 months
* Participants who have been using a ResMed cloud connected AirSense10 or AirSense 11 device compatible with AirView, for more than 12 months
* Participants currently using a suitable mask system\*
* Participants who can trial the masks for up to 7 nights each

  * Note\*: Suitable mask system includes any tube down full face mask (e.g. AirFit F30, AirFit F20, AirTouch F20, AirFit F10, Quattro Air, Quattro Fx, Mirage Quattro, Simplus, Amara, Amara Gel, Comfort gel Full Face Mask, Evora Full)

Exclusion Criteria:

* Participants using Bi-level flow generators
* Participants who are or may be pregnant
* Participants with a pre-existing lung disease/ condition that would predispose them to pneumothorax (for example: COPD, lung cancer; fibrosis of the lungs; recent (\< 2years) case of pneumonia or lung infection; lung injury.
* Participants who or whose bed partner has implantable metallic implants in the head, neck and chest region affected by magnetic fields (Non-ferrous implants may be acceptable)
* Participants who use a rental unit for AirSense 10 or AirSense 11 device
* Participants believed to be unsuitable for inclusion by the researcher
Azelaic Acid as a Novel Treatment for Central Centrifugal Cicatricial Alopecia (CCCA)

The purpose of this pilot study is to determine if azelaic acid shows potential to be an effective treatment for Central Centrifugal Cicatricial Alopecia (CCCA). In this study, the aim is to compare azelaic acid vs placebo since azelaic acid may increase anti-inflammatory effects that affect the hair growth cycle.

The management of Central Centrifugal Cicatricial Alopecia (CCCA) is challenging due to limited current treatments and a lack of randomized controlled trials. Management focuses on behavioral and styling modifications, in addition to symptomatic relief. Any potentially damaging hair care practices such as chemical relaxers, heat application to the scalp, and the use of hardening gels and sprays are discouraged. Many commonly used therapies are anti-inflammatory in nature, including intralesional steroids, topical steroids, oral antibiotics and increased frequency of hair washing with antidandruff shampoos. These treatments not only lead to improvement in pruritus and tenderness, but in some cases result in increased hair density. Currently, comparison studies of different treatments for CCCA subjects is limited. The aim is to determine if there is an advantage in using one particular anti-inflammatory therapy over another for relieving symptoms and promoting hair follicle regrowth.

Eligibility Criteria:
Inclusion Criteria:

* women eighteen years of age or older
* biopsy-proven and /or clinical diagnosis of CCCA Stage II-IV
* on stable treatment without changes for at least three months
* recruited from outpatient dermatology clinics at the Wake Forest Baptist Health Department of Dermatology

Exclusion Criteria:

* males
Mold Sensitization Associated Severe Asthma Exacerbation

Mold sensitization is associated with severe asthma exacerbation.

Mold sensitization has been reported to be one of the factors that is associated with severe asthma exacerbation (SAE). The objective is to identify the factors that are associated with SAE in asthmatic children particularly mold sensitization.

Eligibility Criteria:
Inclusion Criteria:

* Asthmatic children aged 1-15 years old from Pediatric Allergy and Immunology division with hospitalized due to severe asthma exacerbation in a preceding year and without severe asthma exacerbation in a preceding year

Exclusion Criteria:

* Other serious systemic diseases, pregnant, lactation
Pulmonary Rehabilitation After Minimal Invasive Surgery in Lung Cancer

Morbidity in the post-operative phase of pulmonary surgery is characterised by impairment due to pain, dyspnoea and loss of exercise tolerance. We demonstrated previously that rehabilitation after thoracotomy is limited due to pain. Since minimal invasive surgery is the new standard in lung cancer, resulting in a reduction of postoperative pain, we believe there are new possibilities for post-operative integrated multidisciplinary rehabilitation in lung cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Patients undergoing elective, minimal invasive surgery with intention to cure.
2. Age between 18 and 80 years.
3. ECOG 0 - 2 post-surgery.

Exclusion Criteria:

1. Patients with chronic pain
2. Previous pulmonary surgery
3. Comorbidity limiting rehabilitation

   1. Rheumatoid arthritis
   2. Severe ischaemic heart disease or myocardial failure; EF ≤ 35 %.
   3. Muscle disease
   4. Fibromyalgia
   5. Neurologic disorders (Parkinson disease, CVA and lesions of the spinal cord)
   6. Psychiatric disorders