cyrilzakka/clinical-trials huggingface dataset:
Acceptability & Tolerance of Immediate Versus Delayed Postpartum Contraceptive Implant

To study and compare acceptability and tolerance between breast-feeding post-partum woman, who receive contraceptive implant 48-72 hours after giving birth or at 5-7 weeks after giving birth, using either Levonorgestrel or Etonogestrel contraceptive implant.

* To study and compare acceptability and tolerance between breast-feeding post-partum woman, who receive contraceptive implant 48-72 hours after giving birth or at 5-7 weeks after giving birth, using either Levonorgestrel or Etonogestrel contraceptive implant.
* Participants who wish to attend the study will be invited to choose between Levonorgestrel and Etonogestrel contraceptive implant, then they will be randomized into immediate postpartum or delay postpartum group. They will be follow-up at 6 and 12 weeks after receive contraceptive implant.
* Information about side effects, breastfeeding status, child growth, acceptability and tolerance will be noted using medical records and interviewing, gathering on paper case record forms.
* Sample size N = 60 (30 in each group (Immediate and delay postpartum group, 15 in each subgroup (Levonogestrel and Etonogestrel group)) This number of sample size is already counted with 10% data loss

Eligibility Criteria:
Inclusion Criteria:

* Breast-feeding post-partum woman aged 18-45 years who wish to use contraceptive implant

Exclusion Criteria:

* Pregnant
* Woman who has any medical conditions which is considered contraindicated to use contraceptive implant
* Woman with severe antepartum or peripartum complications
* Woman who is contraindicated to breastfeed.
Influence of Indoor Air Filtration Strategies on Occupant Health Indicators

The purpose of this study is to evaluate whether two different central air purification technologies reduce air pollutant exposure and beneficially influence health as evaluated with a suite of biological markers related to cardiovascular and respiratory disease risk.

This study will test two common types of central air handling unit filtration technologies, high-efficiency particulate air (HEPA) filters and electrostatic precipitators (ESPs), to evaluate the impacts of these technologies on personal exposure to air pollutants and the associated cardiovascular and respiratory health outcomes. HEPA filters remove a high percentage of the particulate matter in the air, as do ESPs, but ESPs also generate ozone, which may have its own detrimental health effects. These air purification technologies will be placed in different combinations with a coarse pre-filter to protect the air exchange machinery (combinations: pre-filter only, pre-filter + HEPA, and pre-filter + HEPA + ESP) in both the residences and offices of study participants living on a factory campus in Changsha, Hunan Province, China. Large dormitories and office buildings with central air handling units are common in China and around the world, and so adding air purification into the central ducts represents a practical strategy to reducing personal exposure to air pollution and related health outcomes. The Changsha area commonly suffers from high air pollution, and the dormitories and offices on this workspace are already outfitted with both HEPA filters and ESPs. Therefore, testing these technologies in this environment presents a natural experimental condition to test the benefits of air purification. The study investigators hypothesize that both the pre-filter + HEPA and pre-filter + HEPA + ESP conditions will reduce particulate matter exposure and reduce biological markers of cardiovascular and respiratory disease compared to the pre-filter alone, but that the ESP will generate enough ozone to lead to lower health benefits than HEPA+pre-filter condition.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults;
* Live and work at the Broad Town work campus in eastern Changsha, Hunan Province, China

Exclusion Criteria:

* Has any of the following diseases: chronic respiratory, cardiovascular, liver, renal, hematological disease; diabetes mellitus;
* Has any other diseases that may confound or complicate the effects of the intervention
* Pregnant females
Non-pharmacological Prevention of Postoperative Delirium by Occupational Therapy Teams

In the world, 230 million surgeries are performed every year and US data indicates that more than a third of patients who undergo surgery are older than 65 years, in which between 10 and 70% develop postoperative delirium (POD). Patients who develop POD have poor outcomes, such as a longer hospital stay, a deterioration in functional and cognitive status, high mortality rates, and an increase in health costs.

Delirium is an entity that in a significant percentage is preventable, thus preventing the development of POD is fundamental. In fact, in older adults hospitalized in the no surgical ward, the implementation of non-pharmacological prevention measures of delirium has consistently shown to significantly prevent the development of this condition. However, limited information is available about the usefulness of non-pharmacological intervention protocols applied in the perioperative context to prevent POD.

The main aim of this project is to determine whether the application of non-pharmacological measures during the perioperative period prevents POD in elderly patients undergoing highly complex elective surgeries.

The hypothesis is that the application of these measures decreases the incidence of delirium in this population.

To determine whether non-pharmacological measures decrease the incidence of POD during the perioperative period in elderly patients undergoing highly complex elective surgeries, it will be performed a randomized clinical trial, where two groups of patients older than 75 years undergoing highly complex elective surgeries will be compared:

1. The first group will receive a protocol of non-pharmacological interventions implemented by occupational therapy teams to prevent delirium plus standard non-pharmacological prevention interventions.
2. The second group will only receive standard non-pharmacological prevention interventions.

This study will be carried out in the surgical units of the Hospital Clinico de la Universidad de Chile (HCUCH) and in the Hospital San Jose (HSJ).

The expected result is to demonstrate that the interventions carried out by occupational therapists decrease the incidence of DPO in a significant way in comparison with standard prevention intervention.

Eligibility Criteria:
Inclusion Criteria:

* Hospital admission for highly complex elective surgery

Exclusion Criteria:

* History of cognitive impairment.
* A low score in Mini-Mental State Examination (MMSE): \<23 points if the patient has 6 or more years of schooling, and \<18 points if the patient has \<6 years of schooling.
* Severe communication disorder and cultural language limitation (language other than Spanish).
* Delirium on admission or prior to the start of the intervention (measured with CAM).
* Patient enrolled in another study
Identification of Genetic Markers for Cardiopulmonary Diseases (Genotype)

This study is designed to investigate whether an association exists between certain genes/protein levels and the development of various cardiopulmonary diseases. It is hoped that this project will provide valuable insight into the understanding of these diseases.

There are two main groups of participants in this trial:

Group 1: Patients that are enrolled in either or both of previous studies: X980515002 study (Identification of Genetic Markers for Primary Pulmonary Hypertension) and or X030403017 study (Pulmonary Arterial Hypertension (PAH) Database)

Group 2: Participants with the diagnosis of any of the previously listed Cardiopulmonary Diseases who are ≥15 years of age

Group 1: For those patients who have had blood samples drawn as a result of participating in the current protocol, Identification of Genetic Markers for Primary Pulmonary Hypertension study (X980515002), we would like to use their previously obtained blood and continue to draw samples (12mL; less than 3 tablespoons) ONLY if they change disease therapies. With each disease therapy change, blood will be drawn at baseline, at 3-4 month, at 6-8 month, at 12 month, and at 24 month visits. These current X980515002 participants WILL sign a consent form to participate in this new trial. As for the X980515002 expired patients, we would like to use the previously obtained data ONLY in part for this study that was collected as a result of the X980515002 study.

For those patients who participated in Pulmonary Arterial Hypertension (PAH) Database study (X030403017), these participants WILL also sign a consent form to participant in this new trial. We would like to use the previously obtained data from the X030403017 in part with this study. With each disease therapy change, a 12mL (less than 3 teaspoons) blood sample will be drawn at baseline, at 3-4 month, at 6-8 month, at 12 month, and at 24 month visits. As for the X030403017 expired patients, we would like to use the previously obtained data in part for this study that was collected as a result of the X030403017 study.

Group 2: After signing a consent form, these participants will have a 12mL (less than 3 teaspoons) blood sample drawn at baseline, at 3-4 month, at 6-8 month, at 12 month, and at 24 month visits. With each disease therapy change, the blood draws (12mL samples) will begin again at baseline and continue through the 3-4, 6-8, 12, and 24 month visits.

Eligibility Criteria:
Inclusion Criteria:

* Participants with the diagnosis of any of the previously listed Cardiopulmonary Diseases who are ≥15 years of age will be approached and offered the opportunity to participate in this study.
A 6 Month Study Comparing Latanoprost With Timolol in Patients With Open Angle Glaucoma or Ocular Hypertension

PhXA41 is not inferior to timolol


Eligibility Criteria:
Inclusion Criteria:

* Unilateral or bilateral primary open angle glaucoma, capsular glaucoma, pigmentary glaucoma or ocular hypertension.
* Open angle glaucoma appearing more than 6 months after cataract surgery is recognized as primary open angle glaucoma. (individuals requiring treatment bilaterally must fulfill eligibility criteria for both eyes.)
* IOP of 22mmHg or higher obtained during the pre-study period.
* Patients currently not treated or on single-drug treatment for the elevated IOP are eligible after a medication free period (wash-out) of:

  1. 3 weeks for B-adrenergic antagonists
  2. 2 weeks for adrenergic agonists
  3. 5 days for cholinergics and oral carbonic anhydrase inhibitors.

Exclusion Criteria:

* History of acute angle closure.
* Severe trauma at any time.
* Intraocular surgery or argon laser trabeculoplasty within 6 months.
* Current use of contact lenses.
* History of severe dry eye syndrome.
* Ocular inflammation/infection with three months of inclusion.
* Any condition preventing reliable applanation tonometry.
* Unacceptable finding at pre-study ocular examination as specified in the Case Report Forms.
* In Investigator regards monotherapy insufficient with respect to optic nerve head and/or visual field status.
* Treatment of elevated IOP with any topical B-adrenergic antagonist regularly for a period longer than 3 months and/or treatment at any time during 6 months prior to study start.
* Cardiac failure, sinus bradycardia, second and third degree of atrio-ventricular block.
* Bronchial asthma, history of bronchial asthma or chronic obstructive pulmonary disease.
* Having participated in any other clinical study within the last month.
Verify the Effectiveness rTMS Using MEG

The purpose of this study is to determine whether rTMS are effective in the treatment of tinnitus

Repetitive transcranial magnetic stimulation (rTMS) of the dorsolateral prefrontal cortex (DLPFC) has an add-on effect for primary auditory cortex rTMS in improving tinnitus-related distress. We aimed to investigate whether rTMS of the dorsolateral prefrontal cortex and primary auditory cortex are capable of reducing tinnitus loudness. Linked to a neuronavigation system that is guided by magnetic resonance imaging (MRI) of the frontal and temporal, rTMS can suppress areas of cortical plasticity. This cortical reorganization can be demonstrated by magnetoencephalography (MEG)

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of chronic tinnitus
* Chronic subjective tinnitus for more than 6 months
* Pure tone average \<50 dB HL in the ear where tinnitus is perceived
* Dominant tinnitus frequency measured between 4 and 8 kHz
* Subject is naive regarding rTMS
* Other concurrent treatments: A four-week washout from any other tinnitus
* treatment or management program is required prior to entering this study
* Stable enough to complete this study per the opinion of the Study Physician
* No restrictions, provided the dosages have been in place for at least 3 months
* A three month washout from any other tinnitus treatment or management program is required prior to entering this study.

Exclusion Criteria:

* Objective tinnitus or tinnitus with treatable cause
* Absolute thresholds \> 60 dB on individual frequencies up to 8 kHz
* Presence of intracranial or intraocular ferromagnetic materiel or particles Cardiac pacemaker or other electronic implants (including cochlear implant)
* Serious heart disease or other unstable major medical condition

Personal history of central nervous system disorder, head injury, stroke or seizures

* Familial history of epilepsy;
* Concomitant medication with antidepressants and antipsychotics
* Pregnant women
* Severe depression
* Severe anxiety
* Others known contraindications to rTMS or brain MRI
Computer-Assisted Versus Manual Hair Harvest Comparative Study

The objective of this clinical study is to investigate and compare the safety and efficacy of the Restoration Robotics Computer-Assisted Harvesting System to the manual hair follicle harvesting method following a nine-month period of post-procedural evaluation.

A major technical step in hair transplantation is harvesting of the hair follicles. There are two accepted techniques for obtaining the hair grafts that are transplanted during the procedure. The first is donor strip harvest and stereomicroscopic dissection of the follicular unit grafts. The second is dissection and extraction of the follicular unit graft directly from the patient's scalp referred to as Follicular Unit Extraction or "FUE". Potential benefits of the FUE technique may be less scalp scarring in the Donor Area, less patient discomfort and faster wound healing. Although the FUE approach to harvest has highly desirable attributes, it is technically difficult to perform, labor intensive, tedious and requires an excessive amount of time to harvest follicular units. These procedural factors have prevented the FUE approach from gaining wider adoption.

Restoration Robotics, Inc. has developed the Restoration Robotics ARTAS™ Computer-Assisted Harvesting System to assist physicians in the harvest of hair follicles during hair transplantation procedures. The System mimics the manual FUE approach to harvesting follicular units and has the potential to solve the technical challenges inherent in the manual FUE technique. The ARTAS™ System is capable of identifying and harvesting hair follicles directly from the patient's scalp through a semi-automated process. The goal of the ARTAS™ System is to harvest the hair follicles while maintaining their critical anatomic structures intact.

Eligibility Criteria:
Inclusion Criteria:

* Subject is male with clinical diagnosis of androgenic alopecia with Norwood-Hamilton grade of IV-VII
* Subject is 30 to 59 years old
* Subject has black or brown hair color
* Subject has straight hair
* Subject agrees to cut hair short (\< 1 mm) on the scalp in the designated study areas for harvesting and implantation
* Subject agrees to have two dot tattoos placed on scalp
* Subject is able to understand and provide written consent; and
* Subject consents to post-operative follow-up per protocol.

Exclusion Criteria:

* Subject has preponderance of grey/white hair
* Subject has blonde hair
* Subject has red hair
* Subject uses hair dye
* Subject has prior history of hair restoration procedure(s) using the strip excision technique
* Subject has prior history of scalp reduction surgery(s)
* Subject has helical hair (curly hair)
* Subject has wavy hair
* Subject has bleeding diathesis
* Subject has active use of anti-coagulation medication
* Subject has used finasteride in the previous 6 months, or plans to use finasteride during the study
* Subject has used minoxidil in the previous 2 weeks, or plans to use minoxidil during the study; or
* Subject has any other condition that, in the opinion of the investigator, makes the subject inappropriate to take part in this study.
SYR-472 Open-label Study

To evaluate the efficacy and safety of treatment with SYR-472 in diabetic patients.


Eligibility Criteria:
Inclusion Criteria:

-1. The participant is judged to be capable of understanding and complying with protocol requirements by the investigator or subinvestigator.

2. The participant can sign and date a written, informed consent form prior to the initiation of any study procedures.

Exclusion Criteria:

-1. The participant has concurrent serious cardiac disease, serious cerebrovascular disorder, or serious pancreatic or hematological disease

. 2. The participant is assessed to be ineligible for the study by the investigator or subinvestigator.
Effects of URI on Diabetic Subjects Utilizing Technosphere Insulin After a Meal Challenge

Effect of upper respiratory infection (URI) on diabetic subjects with a meal challenge


Eligibility Criteria:
Inclusion Criteria:

* Subjects will have met the same inclusion criteria as MKC-TI-030
* Clinical diagnosis of URI with in 24 hrs prior to clinic visit and/or day of clinic visit
* At least 3 URI symptoms

Exclusion Criteria:

* Prior participation in MKC-TI-112
* MedHist, PE or lab findings of acute bacterial infection including but not limited to sputum prod., nasal/eye discharge, chest exam abnormalities, CXR findings of pneumonia.
To Study the Use of Humanized CD25 in Preventing the Relapse of Psoriasis Vulgaris

This study is designed to study disease relapse after NBUVB and how the administration of Daclizumab/placebo alters disease relapse.

The first part of the study involves NB-UVB light treatment, a well-established treatment to treat psoriasis. In the second part, we are testing a drug known as Humanized CD25 Monoclonal Antibody (anti-TAC) or placebo to prevent disease relapse. Anti-TAC is an injectable medicine that is also designed to treat psoriasis by blocking a part of the immune system that we believe contributes to the disease.

Eligibility Criteria:
Inclusion Criteria

1. Male or female patients with chronic psoriasis vulgaris (disease stable or worsening for \> 6 months). Patients age 16 - 21 will be considered on a case to case basis.

   For those patients under the age of 18, parental consent will be obtained.
2. Extensive skin involvement.
3. Scale, thickness, and erythema in individual psoriasis lesions of at least moderate intensity.
4. Psoriasis treated with emollients only for 2 weeks prior to treatment
5. Patients with active psoriatic arthritis, if accompanied by psoriasis vulgaris involving more than 5% of the body surface.
6. Patients that are appropriate for treatment with UVB.

Exclusion Criteria:

1. Positive serology for HIV, Hepatitis B, or Hepatitis C.
2. Positive β-HCG titer. For women of childbearing potential, unwillingness or inability to use a contraceptive device during this study if negative for β-HCG.
3. Guttate psoriasis, pustular psoriasis, or whole body erythroderma.
4. Active infection or persistent fever of unknown origin.
5. Major concurrent illness, which could worsen following treatment with anti-TAC.
Comparison of the Ankle-Brachial Index Measurement Using a Specific Oscillometric Device vs. the Doppler Method

Several methods are available to measure ankle brachial index (ABI) non-invasively. A recent scientific statement of the AHA considers the Doppler method as the reference. However because Doppler devices are not widely available in primary care, several attempts have been made to propose alternative methods, among whom oscillometric methods (automatic blood pressure machines) have attracted most attention.

We hypothesize that:

- the diagnostic characteristics (i.e. sensitivity, specificity and AUC) of the oscillometric method would be very good as compared to the Doppler method.

the oscillometric method would have better intra- and inter-observer reproducibilities as compared to the Doppler method.


Eligibility Criteria:
Inclusion Criteria:

Patients referred with the suspicion of PAD, either because of:

* symptoms in favor of intermittent claudication or more atypical pain when walking, or
* asymptomatic individuals with the presence of at least 2 cardiovascular risk factors among the following :

  * Men \> 60 years or women \> 65 years
  * Regular cigarette smoking \>10 years, either current or in the past
  * Treated Type-2 diabetes \>5 years or Type-1 diabetes \>20 years
  * Treated hypertension
  * High blood cholesterol (either total-C \>240 mg/dl or LDL-C \>160 mg/dl) or treated by statins or other lipid-lowering agents
  * Documented history of coronary artery disease (history of PCI or CABG, or previous myocardial infarction, or CAD documented by coronary angiography)
  * Documented history of ischemic stroke

Exclusion Criteria:

* Patients with revascularized PAD
* Patients with critical limb ischemia or leg/foot ulcers
* Cardiac arrhythmia: Atrial fibrillation, atrial flutter, frequent supra- and ventricular ectopic beats
* Patients under dialysis
Palatability of Oral Rehydration Solutions

The primary objective of this study is to compare the mean taste scores for three fruit flavored oral rehydration solutions in children aged 5-10 years old. The secondary objective is to compare the proportions of children who indicate a taste preference for one of the solutions.

In Canada, acute gastroenteritis remains a major cause of morbidity and hospitalizations. This, in large part, is due to an inability to realize the full benefits of oral rehydration therapy. Because oral rehydration solutions have a salty taste, many mild to moderate dehydrated children refuse to drink them. This has resulted in pediatricians recommending inappropriate solutions and the unnecessary administration of intravenous fluids. Although two meta-analyses have concluded that rice-based ORS (Enfalyte) is as or more effective than traditional ORS in reducing stool output, the palatability of different oral rehydration solutions have never been evaluated.

This will be the first prospective trial comparing the palatability of the most commonly recommended oral rehydration solutions, Pedialyte and Enfalyte with a newer solution, Pediatric Electrolyte. Both Pedialyte and Pediatric Electrolyte contain sucralose, dextrose, and fructose while Enfalyte contains rice syrup solids. Although the latter is as, or more effective than Pedialyte in reducing stool output, palatability may limit its use. Taste is important as children with gastroenteritis are frequently nauseated and may refuse to drink or vomit when consuming less palatable solutions.

We hypothesize that, compared to children who receive a rice-based ORS (Enfalyte), those who receive a sucralose ORS (Pediatric Electrolyte or Pedialyte) will report a higher mean taste score, will prefer to drink the sucralose sweetened ORS if they had to consume a larger volume, and are more likely to drink the entire volume they are provided.

Eligibility Criteria:
Inclusion Criteria:

* Children 5-10 years of age evaluated in The Hospital for Sick Children's emergency department

Exclusion Criteria:

* Children with diarrhea, a vomiting or diarrhea episode within 24 hours, head trauma, abdominal pain, upper respiratory symptoms, or nil per os status
* Patients with gastrointestinal symptoms