cyrilzakka/clinical-trials huggingface dataset:
Randomized Controlled Trial of Long-term Treatment Effectiveness for Meibomian Gland Dysfunction (MGD) and Dry Eye

The study objective is to evaluate the long-term treatment effectiveness for adult patients with meibomian gland dysfunction (MGD) and evaporative dry eye by: 1) comparing the LipiFlow® System to a standardized daily warm compress and eyelid hygiene control therapy over a duration of 3 Months; and 2) evaluating the LipiFlow® alone and in combination with other MGD and dry eye treatments over a duration of up to 12 Months.

This is a post-market, non-significant risk, prospective and multi-center clinical trial divided into two stages. The first stage from enrollment to 3 Months is an open-label, randomized controlled design to compare the effectiveness of a single LipiFlow® System treatment to a standardized daily warm compress and eyelid hygiene Control therapy with Crossover LipiFlow® treatment of the Control subjects at 3 Months. The second stage, occurring between 3 and 12 Months, is an observational design to evaluate the effectiveness of LipiFlow® alone and in combination with other MGD and dry eye treatments over a duration of up to 12 Months. Subjects are entered into the following subgroups based on the subject's self-assessment of the adequacy of symptom relief and protocol-defined criteria for additional treatment.

1. One LipiFlow® Treatment: Subjects who receive only one LipiFlow® treatment.
2. Two LipiFlow® Treatments: Subjects who receive a second LipiFlow® treatment.
3. Combination Treatment: Subjects who receive one or two LipiFlow® treatments followed by other MGD or dry eye treatment, as prescribed by the physician.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old
* Tear film assessment that qualifies in both eyes
* Evidence of meibomian gland dysfunction and dry eye in both eyes
* Willingness to comply with study protocol

Exclusion Criteria:

* Systemic disease condition or medication that causes dry eye
* Use of other treatments for MGD or dry eye
* Ocular surgery, trauma, herpes infection, punctal plug insertion or punctal occlusion within past 3 months
* Active eye infection
* Active eye inflammation or recurrent inflammation within past 3 months
* Moderate to severe allergic conjunctivitis
* Severe eyelid inflammation
* Eyelid abnormality that affects lid function
* Ocular surface abnormality that may compromise corneal integrity
* Pregnant or nursing women
* Participation in another ophthalmic clinical trial within past 30 days
Anomalies of Nocturnal Gaz Exchanges in Patients With Down Syndrome

Recently, retrospective studies have shown that Down Syndrome children have a higher CO2 (carbone dioxide) sleep pressure than the general pediatric population. This increase does not seem to be always related to sleep apnea. The Investigators wish to confirm these results prospectively. The investigators hypothesize that this alveolar hypoventilation may be due to ventilatory control disorders caused by dysautonomia, but also to a decrease in the strength of the respiratory muscles within the framework of the global muscular hypotonia described in children with Down syndrome. .

47 Down syndrome patients age from 4 to 16 will be included. They will perform a medical visit at J0, then a measurement of gaz nocturnal exchanges at home within 1 month

Eligibility Criteria:
Inclusion Criteria:

* Down syndrome patient without mosaicism
* Age 4 to 16 years
* Predominant French language in the living environment

Exclusion Criteria:

* OAS diagnostic focused on an earlier polysomnography
* Methylphenidate treatment started before inclusion
Efficacy of Sensory Electrical Stimulation Versus Alternating Electromyogram (EMG) On Functional Recovery Of Hand in Chronic Stroke Survivors :Randomized Controlled Trial

This study aims to find out which treatment works better for improving hand function in stroke patients: sensory electrical stimulation or alternating electromyogram (EMG) stimulation. Both methods use electrical stimulation to help patients regain hand movement, but they work in slightly different ways. The goal is to see if one method is more effective than the other in helping stroke survivors recover their hand abilities.


Eligibility Criteria:
Inclusion Criteria:

* Chronic stroke patients were between 45 and 65 years old, with a duration of illness ranging from 6 to 18 months post-stroke. They exhibited upper extremity spasticity no greater than 1+ on the Modified Ashworth Scale. Patients were cooperative, as indicated by a Mini-Mental State Examination (MMSE) score of ≥ 24, and were capable of grasping and releasing at least one block in the Box and Block Test.

Exclusion Criteria:

* Hand function impairment caused by factors other than stroke, unstable health conditions such as cardiac dysfunction, end-stage renal failure, or uncontrolled diabetes, long-term use of medications that may affect motor or sensory excitability, contractures or restrictions in wrist joint range of motion, pre-existing musculoskeletal diseases significantly impacting physical function, and a history of Botulinum Toxin injection in the hand muscles.
Characteristics of SARS-CoV-2 Reinfection

As the COVID-19 pandemic continues and the number of individuals with previous infection rises, numbers of SARS-CoV-2 reinfection are increasing. The second Omicron wave in Shanghai, China caused by BA.5-sublineages led to a large fraction of reinfections among BA.2 primary infections. To better understand the SARS-CoV-2 reinfection rate and clinical severity of reinfections, the investigators conducted a multi-centre cohort study. The investigators hope to provide valuable clinical evidences for reinfections and offer guidance for future policy making.

The investigators used data from Huashan Hospital, Renji Hospital, and Shanghai Jing' an Central Hospital to collect information on SARS-CoV-2 primary infections with BA.2 during 1 March to 23 May 2022, and followed up for participants' reinfections with BA.5-lineages during 1 December 2022 to 14 January 2023. After matched 1:1 by age and gender with the reinfection cohort, data of primary infections with BA.5-sublineages were also collected. Reinfection cases were defined as having positive COVID-19 PCR or antigen test, at least 90 days after participants' first positive testing. Basic information, vaccination status, time interval between two infections, and clinical manifestations were collected.

Eligibility Criteria:
Inclusion Criteria:

* All PCR- or RAT-confirmed SARS-CoV-2 reinfections were included in the study.

Exclusion Criteria:

* Patients who did not know if they were reinfected were excluded.
Effectiveness of a Digital Health Application for Multiple Sclerosis (Levidex)

The trial aims to evaluate the effectiveness of a novel digital health application (levidex), which was designed to increase quality of life in persons with multiple sclerosis (MS). Therefore, 470 people with MS will be recruited and randomized to two groups: (1) an intervention group that will receive access to levidex in addition to treatment as usual (TAU) (n = 235) and (2) a control group receiving an overview of relevant brochures from the Deutsche Multiple Sklerose Gesellschaft (German Multiple Sclerosis Society) on the topic of lifestyle in MS in addition to TAU (n = 235).The primary outcome measure is the total score on the Hamburg Quality of Life Questionnaire for Multiple Sclerosis (HALEMS), collected 6 months post-randomization.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* Impaired health-related quality of life (total score of the Hamburg Quality of Life Questionnaire for Multiple Sclerosis \[HALEMS\] ≥ 2)
* Specialist treatment in the last three months before study inclusion
* Diagnosis of MS (relevant ICD-10-GM diagnoses G35.x), confirmed by a medical document or equivalent certificate
* Sufficient cognitive and motor skills to use an online program
* Consent to participate
* Sufficient knowledge of the German language
* Access to the Internet

Exclusion Criteria:

* Presence of severe impairment of independence or abilities (degree of care \["Pflegegrad", § 15 SGB XI\] ≥ 3)
Visualization of the Effect of Acupuncture on Brain Serotonin in Breast Cancer Survivors

RATIONALE: New imaging procedures, such as single photon emission computed tomography, may help in learning how acupuncture affects serotonin levels in the brain of breast cancer survivors. PURPOSE: This phase I trial is studying the best way to visualize the effect of acupuncture on brain serotonin in breast cancer survivors.

Detailed Description

OBJECTIVES:

I. To determine the feasibility of using \[123-I\] ADAM Serotonin transporter (SERT) binding as a putative biomarker to visualize the mechanism of effects of acupuncture for hot flashes involving serotonin.

OUTLINE: Patients undergo acupuncture twice weekly for 2 weeks and then once weekly for 6 weeks. Patients undergo single photon emission computed tomography imaging with iodine 123-I ADAM before and after completion of acupuncture.

After completion of study treatment, patients are followed for 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* History of Stage I, II, or III breast cancer for at least 12 months
* Have been seen by an oncologist within the previous 6-month period and determined to be free of disease by clinical examination and history
* Have been receiving endocrine therapy (tamoxifen or aromatase inhibitors for at least four weeks)
* Experienced hot flashes with a hot flash composite score of 5 or greater per day
* Hot flashes have been present for at least a month before study entry

Exclusion Criteria:

* Currently on chemotherapy or radiation therapy as adjuvant treatment
* Started with hormonal therapies such as tamoxifen or aromatase inhibitors within the last 4 weeks; or plan to change or terminate hormonal therapies in the next 14 weeks
* Any history of use of psychotropic medication such as SSRI use for the past 6 months
* Any past use of centrally acting medications such as clonidine for the past 6 months
* Any past diagnosis of a Major Depressive Episode within the last 6 months
* Any allergy to iodine or shell-fish or radio-nuclear materials
* Current use of estrogen and/or progestin
* Pregnancy
* Breast feeding
* Women of child-bearing potential NOT willing to use a medically acceptable form of contraception
* Current use of any anti-convulsant such as gabapentin
* History of cerebral infarction (including lacunar infarct with symptoms \>= 24 hours duration)
* History of Binswanger's disease (or a history of hypertensive encephalopathy)
* History of intracranial hemorrhage
* History of head trauma with loss of consciousness
* History of encephalitis
* History of extended exposure to known neurotoxin (e.g., cyanide, carbon monoxide)
* Uncontrolled metabolic disorder (e.g., thyroid disease, diabetes mellitus)
* History of normal pressure hydrocephalus
* History of Parkinson's or other basal ganglia disease
* History of substance abuse in the previous 6 months
Effect of Multi Strain Probiotic on Ferritin Levels in Children with Iron Deficiency

The goal of this clinical trial is to learn about the effect of multi-strain probiotic (bacteria and yeast) on ferritin levels in children age 1 - 18 years old who had iron deficiency in 15 orphanages of Makassar city. The main questions it aims to answer are:

• Are ferritin levels in iron deficiency children given iron standard therapy with multi-strain probiotics (bacteria and yeast) higher than those given iron standard therapy with placebo? Researchers will compare iron standard therapy with multi-strain probiotics (bacteria and yeast) to a placebo to see if muti-strain probiotics works to treat iron deficiency in children.

Participant will :

* Take iron standard therapy with multi-strain probiotics (bacteria and yeast) or iron standard therapy with placebo every day for 30 days
* Ferritin levels were evaluated on day 31

The aim of this study was to assess the effect of multi-strain probiotic (bacteria and yeast) on ferritin levels in children with iron deficiency treatment. It is a randomized controlled trial (RCT) conducted in 15 orphanages of Makassar city in children aged 1 - 18 years. The study population was children aged 1 - 18 years who had iron deficiency. Eligible children are randomized into two groups - an intervention group receiving standard iron therapy with multi-strain probiotics (bacteria and yeast) and a control group receiving standard therapy with placebo. The primary outcome is serum ferritin levels, measured at baseline and after 30 days of intervention. Blood samples are collected to measure ferritin levels. The study aims to enroll 80 infants (40 per group) to detect a clinically meaningful difference in ferritin levels between groups. This trial will provide evidence on whether multi strain probiotic can increasing ferritin levels in children with iron deficiency treatment. The results may inform clinical practice regarding the use of probiotics multi strain as an adjunctive therapy for iron deficiency in children.

Eligibility Criteria:
Inclusion Criteria:

* Children with iron deficiency
* Age 1 year - 18 years
* The parent or person in charge of the foundation signed the informed consent that the child was willing to be included in the study.

Exclusion Criteria:

* Iron deficiency children with infection, renal impairment and hepatic impairment were identified through interviews with caregivers and physical examination of the children.
* Children with immunocompromise (malignancy, malnutrition, HIV).
* Iron deficiency children who have received iron therapy and last consumed 3 months prior to the study.
* Iron deficiency children who were temporarily receiving iron therapy or iron supplementation.
Dancing for Better Aging: Evaluating the Impact of a Dance/Movement Therapy (D/MT) Program for Older Adults

The aim of this study is to empirically evaluate the impact of a Dance/Movement Therapy program adapted to older adults. Participants over 60 years old are enrolled in one of three groups: Dance/Movement Therapy, Aerobic Exercise or Waiting List (control group) for 12 weeks. The training groups occur 3 times a week for 1 hour each session. Physical condition, cognitive function, general health and lifestyle, and stress hormones are assessed at baseline, after 12 weeks and after 28 weeks.


Eligibility Criteria:
Inclusion Criteria:

* aged 60 years and older
* sedentary or moderately sedentary (less than 150 minutes of moderate to vigorous exercise per week)
* have not participated in another similar study in the last year
* have not been exposed to a dance or dance/movement therapy program in the past year
* are not in a wheelchair
* have not had surgery in the past year
* have not smoked in the past 5 years
* do not consume more than 2 glasses a day of alcohol
* are not in treatment for major depression

Exclusion Criteria:

* progressive neurological disorder
* unstable medical conditions (unstable cardio illness in the past 6 months, cardiac or thyroid troubles or pituitary gland illness)
* contraindication for moderate physical activity (major orthopaedic limitations)
* suspicion of cognitive problems (score of 24 or less on the Mini-Mental State Examination)
* large uncorrected perceptual limits
* treatment of hormone therapy
* uncontrolled hearing loss
Improving Access to Eye Care in Glaucoma Patients

1. To design and develop a prospective, randomized pilot study utilizing information from electronic medical records to address follow-up adherence and reduce the gap between recommended and actual follow-up adherence in patients with glaucoma.
2. To evaluate the impact of a telephone-based intervention on follow-up adherence in patients with glaucoma using a randomly assigned comparison with usual care.

The Wills Eye Health System (WEHS) proposes to conduct a pilot study to evaluate the feasibility and effectiveness of a telephone-based intervention to improve rates of follow-up exams in patients with glaucoma. The prospective, randomized, controlled trial entitled "Improving Access to Eye Care in Patients with Glaucoma" will utilize cohort data from 2013 electronic medical record information to reduce the gap between recommended and actual follow-up utilization of eye care services in glaucoma patients. Patients with glaucoma will be recruited from the Wills Eye Glaucoma clinic who were seen between 3/1/13 and 10/31/13. A recall list will be generated for patients who have scheduled follow-up appointments from 9/1/13 to 11/30/13. These patients will be randomly assigned to the "Usual Care" group or "Intervention" group. The primary outcome will be successful attendance at a follow-up appointment within an appropriate time frame. This intervention is based on a CDC funded project at Wills to improve access to eye care in patients with diabetes. Thus, this pilot study will test the efficacy of a telephone-based intervention to improve follow-up adherence in patients with glaucoma by improving access to eye care.

Eligibility Criteria:
Inclusion Criteria:

* Attended Wills Eye Glaucoma Clinic from 9/1/12 and 10/31/13

Exclusion Criteria:

* Any medical condition that would preclude the subject from providing reliable and valid data.
* Recommended to f/u in less than 1 month time period.
Remifentanil and Nitroprusside for Controlled Hypotension

The purpose of this study is the comparison of the cardiovascular effects of remifentanil and nitroprusside for controlled hypotension


Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent endoscopic sinus surgery

Exclusion Criteria:

* patient who took any drug to influence this study
* patient with cardiovascular disease, renal disease or liver disease
Follow-up Study After ACLSCT for Restoration of Corneal Epithelium in Patients With LSCD Due to Ocular Burns

This is a multinational, multicentre, prospective, non-pharmacological follow-up study of the clinical trial HOLOCORE. All patients transplanted with Holoclar in the HOLOCORE clinical trial who consent to participate will be enrolled in this prospective study and observed for at least 12 months.

HOLOCORE FOLLOW-UP prospective study offers the opportunity to collect long-term efficacy and safety data after one or two treatments with Holoclar. Moreover, since Holoclar (study drug used in the main HOLOCORE interventional clinical trial) is suspected to improve the success of keratoplasty in those patients candidate to receive this treatment but no data were collected in the three previous retrospective studies (HLSTM01, HLSTM02 and HLSTM04) on Holoclar, this follow-up study has been thought to observe the progress of the disease and to collect data on keratoplasty and evaluate the benefits of Holoclar in subsequent keratoplasty in patients treated once or two times with Holoclar.

All patients treated in the HOLOCORE clinical trial who consent to roll over to the present extension study at the end of the HOLOCORE will be observed for a follow-up period which may vary from a minimum of 12 month for the last patient to a maximum of 57 months for the first patient entered.

A total of approximately 70 patients is expected (all patients who completed the HOLOCORE study).

In case the last enrolled patient undergoes to Keratoplasty at the Last Visit of the Follow-up study, this will consequently lead to a prolongation of the study up to further 12 months for all patients.

The subjects will be enrolled and observed at the same investigational centers where they were recruited for the HOLOCORE clinical trial.

No drug will be administered for the scope of this study. Ophtalmological visits including pictures collection and quality of life evaluations will be performed every 6 months.

Eligibility Criteria:
Inclusion Criteria:

* All patients (adults and pediatrics) who completed the HOLOCORE core study and who consent to roll over to the present extension study at the end of the HOLOCORE follow-up.

Exclusion Criteria:

* No specific exclusion criterion is considered for this study, except for patients dropping out from the HOLOCORE study or withdrawing consent.
Can Rhodiola Crenulata Intake Improve Oxygen Saturation and Decrease the Incidence of Acute Mountain Sickness

Traditional folk medicine in the Arctic and Himalayan areas used Rhodiola species to enhance physical endurance, prevent aging, resist acute mountain sickness (AMS), and to treat fatigue, depression, anemia, impotence and respiratory infections. Rhodiola crenulata are widely used to prevent AMS in Himalayan areas and Lhasa in Tibet but none was examined by human study. The investigators conducted a randomized, double blind, placebo controlled, crossover study to investigate the efficacy of Rhodiola crenulata in preventing AMS.

The number of people traveling to altitude for work or for recreation is rising, and increased media attention towards these activities has also raised the profile of altitude related illness. The most effective preventive measure for acute mountain sickness (AMS)-gradual ascent-is frequently difficult or impractical for modern international travel to locations such as Lhasa in Tibet (3650 m) and La Paz in Bolivia (3740 m). In order to solve this problem, prophylactic acetazolamide was most commonly used. But prescription needed and side effects such as paresthesia and nausea are the disadvantage of using acetazolamide. Some over-the-counter herbal supplements with essentially no adverse effect were widely used, such as Rhodiola species. Rhodiola crenulata are widely used to prevent AMS in Himalayan areas and Lhasa in Tibet but none was examined by human study. The investigators conducted a randomized, double blind, placebo controlled, crossover study to investigate the efficacy of Rhodiola crenulata in preventing AMS.

Eligibility Criteria:
Inclusion Criteria:

* age between 20 and 55 years.
* able to complete the study protocol of 9-day study regimens and mountain climbing twice.
* no prophylactic medication or herb one month before ascent.
* maintaining the same living conditions and habits four months before the first mountain climbing and four months between two mountaineering.

  * living in the same altitude or within a difference of 200 meters.
  * no additional physical training.
  * no plan to gain or loss weight.
  * no altitude exposure above 2500m.

Exclusion Criteria:

* any history of chronic obstructive pulmonary disease, heart failure, cerebral neoplasm, mania, renal or hepatic insufficiency.
* women in pregnancy or intending of pregnancy during the 4-month study period.
Clinical Efficacy of Supraclavicular Block for Arthroscopic Shoulder Surgery

The aim of this study is to compare the efficacy of supraclavicular and interscalene brachial plexus blocks in the patients undergoing arthroscopic shoulder surgery.

This study aims to compare supraclavicular brachial plexus block to interscalene brachial plexus block with regard to degree of sensory and motor blockades, side effects and complications of the blocks, and frequency of intraoperative analgesics or antihypertensives use.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists physical status I-II
* Body mass index \< 35 kg/m2

Exclusion Criteria:

* Neurologic deficits on the side to be blocked
* Infection or inflammation at the puncture site for brachial plexus block
* Psychiatric disorders
* Patient refusal
* Difficulty to communicate
* Coagulation deficiencies