cyrilzakka/clinical-trials huggingface dataset:
Evaluation of FID 114657 in Dry Eye Subjects

The primary objective of this study is to assess the overall Meibomian Gland Dysfunction Subject's preference for a particular product. Dry eye symptom relief will also be evaluated based on clinical evaluation and a set of subject questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Patients must be at least 18 years of age
* must read and sign the informed consent forms (ICF)
* must agree to comply with the study requirements.
* Patients must have a best corrected visual acuity of 0.6 LogMar or better in each eye
* must report having an ocular examination in the last two years
* must be using topical ocular dry eye therapy (artificial tears or Restasis® at least 2 times per day.
* must have been diagnosed with Meibomian Gland Dysfunction / Posterior Blepharitis based on the following criteria: must have dry eye symptoms and Meibomian gland expression grade greater than 1.

Exclusion Criteria:

* Patients cannot wear contact lenses during the study and cannot have a history of hypersensitivity to any component of FID 114657.
* Patients cannot have ocular or intraocular surgery or serious ocular trauma within the past 6 months, and cannot have a history and/or current evidence of active intraocular inflammation in either eye.
* Patients cannot have punctal plugs that were placed less than or equal to 30 days prior to Visit 1, and they cannot have ocular conditions that, in the opinion of the investigator, preclude the safe administration of the test article.
* They cannot have started or changed the dose of chronic systemic medication within 7 days prior to visit 1, and must remain on a stable dosing regimen for the duration of the study.
* Patients cannot have participated in another investigational clinical or research study within 30 days of visit 1.
* Subjects cannot have a history and/or current evidence of the following: epithelial herpes simplex keratitis (dendritic keratitis); vaccinia, active or recent varicella viral disease of the cornea and/or conjunctiva; active ocular rosacea (excluding subjects enrolled with MGD (posterior blepharitis)); acute or chronic bacterial disease of the cornea and/or conjunctiva and/or eyelids; mycobacterial infection of the eye; and/or fungal diseases of the eye.
Examine the Possible Association of Hepatic CYP3A Activity and the Susceptibility to Femur Head Necrosis

The purpose of the present study was to examine the possible association of hepatic CYP3A activity and the susceptibility to femur head necrosis in patients treated with corticosteroids.

Femur head necrosis is one of the major side effects of corticosteroid therapy. Since corticosteroids are metabolized by hepatic cytochrome P-450 (CYP) 3A, a low endogenous activity of this enzyme may contribute to the pathogenesis of ONFH. The purpose of the present study was to examine the possible association of hepatic CYP3A activity and the susceptibility to femur head necrosis in patients treated with corticosteroids.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of avascular necrosis of the femur

Exclusion Criteria:

* Old age (\> 70 years)
* Severe hepatic or renal dysfunction
* Heart disease
* Current use of known CYP3A-inducing or -inhibiting drugs
* Morbid obesity
Electrical Interactions in Heart Disease

This study will evaluate the relationship of markers of cardiac activation and their determinants. The hypothesis is that these markers will be interrelated.


Eligibility Criteria:
Inclusion Criteria:

* ventricular dysfunction

Exclusion Criteria:

* normal ventricular function
An Open-label Study to Evaluate the Long-term Safety and Tolerability of LUM001 in Patients With Primary Biliary Cirrhosis

Open-label, multicenter study in adults with Primary Biliary Cirrhosis (PBC) designed to evaluate the long-term safety and tolerability of daily dosing with LUM001.

This is an open-label study in subjects with PBC who previously completed the LUM001 201 (CLARITY) study. The study is designed to investigate the long-term safety and tolerability of LUM001 treatment, with daily dosing for up to 2 years. Changes over time, compared to baseline, in liver enzymes, other biochemical markers associated with PBC, pruritus, and other quality of life measures will also be assessed.

Eligibility Criteria:
Inclusion Criteria:

1. Completed a core treatment protocol of LUM001 in the treatment of Primary Biliary Cirrhosis.
2. Ability to understand and willingness to sign informed consent/assent prior to initiation of any study procedures.

Exclusion Criteria:

1. Presence of advanced liver disease.
2. History of non-adherence during the subject's participation in the core LUM001 treatment protocol.
Resorbable Barrier for the Prevention of Abdominal and Peri-hepatic Adhesion Formation

The purpose of this study is to evaluate the efficiency of a resorbable barrier membrane for the prevention of abdominal and peri-hepatic adhesion in patients with colorectal cancer requiring two-stage surgery for the resection of hepatic metastases.

Eligible patients will be randomly assigned to one of 2 arms:

* Seprafilm group (receiving resorbable barrier membrane during the first surgery)
* No-treatment control group (without seprafilm barrier during the first surgery)

The primary objective is to establish, in patients with colorectal cancer requiring two-stage surgery for the resection of hepatic metastases, the efficiency of a resorbable barrier membrane (Seprafilm) for limiting abdominal and peri-hepatic adhesion during the second operation.

This study is a prospective multicentric phase II, controlled, randomized and non comparative trial.

A total of 60 patients will be enrolled: 45 will receive Seprafilm whereas 15 will be assigned to the no-treatment control group. The inclusion period should be approximately 18 months. The follow up period after the second surgery will be 3 years.

The secondary objectives of the study are:

During and after the 1st surgical procedure To evaluate immediate complications (during surgery), early complications (during post-surgery hospitalization) and late complications (between 1st and 2nd surgeries) in relation with operating procedure and use of resorbable membrane.

During and after the 2nd surgical procedure

* To evaluate abdominal and peri-hepatic adhesion (at the site of the 1st surgery), with qualitative and quantitative description.
* To evaluate intestinal adhesion (in the small intestine), with quantitative description.
* To evaluate immediate complications (during surgery), early complications (during post-surgery hospitalization) and late complications (in the month following the intervention) in relation with operating procedure.
* To evaluate post-operative rehabilitation
* To assess tumour evolution in patients over a period of 3 years after the 2nd surgery.

Eligibility Criteria:
Inclusion Criteria:

* Women and men aged ≥ 18 years
* Colorectal cancer with synchronous or metachronous hepatic metastases
* Patients requiring two-stage surgery with laparotomy for the resection of hepatic metastases
* The 2 operations should be scheduled in the same centre
* The 2 operations should be scheduled at an interval of 1 to 6 months
* Patient affiliated with social security
* Patient able to read and write French
* Written, voluntary, informed consent

Exclusion Criteria:

* Patient with previous hepatic or biliary surgery through supra-umbilical incision (except biliary surgery with laparotomy more than 6 months previously)
* Patient with previous major surgery except colorectal surgery for resection of primitive tumour
* Metastasis removable in one surgical procedure
* Non resectable metastasis
* Follow-up impossible for social, geographical, familial or psychological reasons
* Patient deprived of freedom
* Patient enrolled in another experimental surgery trial
* Pregnant or lactating woman
The Role of Sleep in the Treatment of Cannabis Use Disorders

The number of people seeking treatment for marijuana-related problems is on the rise, yet there is no currently accepted medication proven to help them quit. Frequent marijuana users have reported that they have trouble sleeping when they try to quit, and that the loss of sleep can lead to relapse. This research is designed to measure the severity of sleep problems in people as they are trying to quit heavy use of marijuana, and to investigate whether extended-release zolpidem (Ambien CR®) can improve quit rates among people trying to stop using marijuana.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-55 years.
2. Recent problematic use of cannabis
3. Cannabis use impacts sleep

Exclusion Criteria:

1. Dependent on drugs other than cannabis or nicotine, or current Axis I psychiatric disorder
2. Moderate sleep apnea or periodic limb movement disorder
3. Pregnant, breast feeding, or planning to become pregnant within the next 3 months
4. Current condition associated with severe cognitive/social impairment
5. Allergy to any ingredient in extended-release zolpidem or prior adverse reaction to zolpidem
6. Current use of drugs that affect metabolism via cytochrome P450 or current illness resulting in severe hepatic impairment
7. Current use of hypnotic medications
Pharmacokinetics of Progesterone in Pregnancy

Pharmacokinetic analysis of 200mg vaginal progesterone suppository in women with singleton pregnancies between 18 0/7- 23 6/7 weeks' gestation

Prospective study of 6 women with singleton pregnancies 18 0/7- 23 6/7 weeks' gestation with no prior preterm birth or short cervix who are administered a single dose of 200mg vaginal progesterone suppository. Serum progesterone levels will be drawn serially from pre-dose to 24 hours post-dose.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years old pregnant with singleton gestation 16 0/7 - 23 6/7 weeks
* pre-pregnancy BMI 20-40
* no history of prior preterm birth

Exclusion Criteria:

* history of an adverse reaction to progesterone
* contraindication to progesterone treatment including prior or active thrombus, active hepatic disease, known adverse reaction to progesterone
* medical comorbidity requiring medication including: hypertension, diabetes, substance abuse/methadone maintenance therapy, asthma, thyroid disease
* major fetal anomaly diagnosed on ultrasound or known chromosomal disorder
* multifetal gestation
* vaginal bleeding, preterm labor, premature rupture of membranes, or clinical chorioamnionitis, at the time of enrollment or on Day 1 of study
* any progesterone use of any form previously during the pregnancy
* active vaginitis
* Illicit substance use in pregnancy including cocaine, opiates, marijuana
* abnormal pap smear/+HPV on most recent pap smear
* known or suspected malignancy of the breast or genital organs
* cervical length ≤25mm
CARES Lumbar Artificial Disc Registry

The purpose of the registry is to assess outcomes following treatment with lumbar total disc replacement (TDR) in patients outside the clinical trial setting.

The purpose of this study is to capture outcomes associated with use of total disc replacement (TDR) in patients treated with either the CHARITE™ Artificial Disc or the PRODISC®-L Total Disc Replacement may be included in the registry.

Eligibility Criteria:
Key Inclusion Criteria:

* Treated with the lumbar TDR.
* Signed IRB approved consent document.

Key Exclusion Criteria:

* None known.
Post-Approval Study of the TECNIS® Toric Extended Cylinder Range Intraocular Lens (IOL)

This study is a prospective, multicenter, bilateral, non-randomized, open-label, clinical study conducted at up to 20 sites in the USA. Subjects were to be bilaterally implanted with one eye having an extended cylinder (high cylinder) toric IOL (model ZCT450, ZCT525 or ZCT600) and the fellow eye having a high cylinder toric IOL (model ZCT450, ZCT525 or ZCT600) or a lower cylinder toric IOL (ZCT300 or ZCT400). This study evaluates the outcomes for subjects implanted with at least one higher cylinder toric IOL.

The purpose of this study is to evaluate the performance of the higher cylinder (ZCT450,ZCT525 and ZCT600) toric IOLs. Some subjects had the higher cylinder toric IOLs in both eyes with other subjects having a higher cylinder toric IOL in one eye and the lower cylinder toric IOL in the other eye.

Per the statistical plan, data for the ZCT450/525/600 toric IOLs were to be pooled together and reported as one group.

The primary endpoint is the rate of severe visual distortions reported by subject at 6 months via questionnaire. The analysis population for this endpoint will be bilaterally implanted subjects with a high cylinder IOL (ZCT450/525/600) in the primary eye and a high cylinder IOL (ZCT450/525/600) or a low cylinder IOL (ZCT300/400) in the fellow eye.

There were no formal secondary endpoints. Data from a few other endpoints (rate of IOL repositioning due to IOL misalignment and percent change in cylinder) have been reported. For these endpoints the analysis population contains all subjects implanted with a ZCT450/525/600 in at least one eye.

Adverse events were reported by subject for all subjects with a high cylinder IOL (ZCT450/525/600) in at least one eye.

Eligibility Criteria:
Inclusion Criteria:

* Minimum 22 years of age
* Bilateral cataracts
* Preoperative keratometric cylinder of at least 2.00 D in both eyes with at least one eye having approximately 3.00 D to 4.75 D of corneal astigmatism.
* Ability to understand, read and write English in order to consent to study participation and complete a study questionnaire
* Signed informed consent and HIPAA authorization

Exclusion Criteria:

* Irregular corneal astigmatism
* Any corneal pathology/abnormality other than regular corneal astigmatism
* Previous corneal surgery or recent ocular trauma or intraocular surgery that is not resolved/stable or may affect visual outcomes
* Any pupil abnormalities
* Subjects with conditions associated with increased risk of zonular rupture, including capsular or zonular abnormalities that may lead to IOL decentration
* Known ocular disease or pathology that may affect visual acuity or that may require surgical intervention during the course of the study
* Concurrent participation or participation during 30 days prior to preoperative visit in any other clinical study
* Planned monovision correction
* Patient is pregnant, plans to become pregnant or is lactating
Electrical Stimulation for Respiratory and Leg Muscles Impact on COPD Patients

Electrical neuromuscular stimulation electrode patches will be applied over the intercostal respiratory muscles and leg muscles

Electrical neuromuscular stimulation electrode patches will be applied over the intercostal respiratory muscles and leg muscles (placed superficially just below each knee, over the head of the fibula, in close proximity to the common peroneal nerve).

Active stimulation consisted of a ∼30-second ramp-up to the titrated intensity value at the start of stimulation, ∼30 minutes at the titrated intensity, and a 10-second ramp-down at the end of stimulation.

Eligibility Criteria:
Inclusion Criteria:

* Patient undergoes four main clinical criteria for the diagnosis of RLS according to the international restless leg syndrome study group (IRLSSG) including

  1. an urge to move legs that is usually associated with paresthesia.
  2. alleviation of the symptoms by moving the legs.
  3. aggravation or exacerbation of the symptoms particularly at rest or during sitting or lying down in the bed.
  4. worsening of the signs at night. patients with diagnosed with grade I and grade II COPD their ages ranged between 45-55 o All patients will be clinically and medically stable when attending the study

Exclusion Criteria:

* History of Deep venous thrombosis

  * History of Bleeding disorders
  * Have an implantable device like a pacemaker
  * Recent Infected wound
  * History of allergic response to the electrodes, gel or tape
  * patients who participating in any other exercise program
  * Loss of sensation or numbness
Plyometric, Proprioceptive and Strength Exercises in Rugby Players.

Introduction. Shoulder injury is the pathology that causes the longest downtime in rugby players, representing 66% of upper limb injuries in this discipline. The lack of strength, and instability are factors that predispose the athlete to suffer this type of dysfunction. The intervention of the study consists of a training program that counteract these dysfunctions.

Aim. Assess the effectiveness of a program using plyometric, proprioceptive and strength exercises on 18-45-year-old rugby players to improve strength and stability.

Study design. Clinical randomized, prospective, single-blind and trackable. Methods. The subjects included in two study groups, experimental and control, will be attributed a random order. The treatment will last 4 weeks, with 2 weekly sessions, of approximately 25 minutes each. The study variables will be strength, stability and functionality. A descriptive statistical analysis will be carried out calculating the main statistical characteristics. Through of a Kolmogorov analysis the normality of the sample will be assessed. A t-Student test for paired samples will be performed for the difference between the means of the dependent and independent variables. An analysis if variance (ANOVA) for repeated measures will be used to compare the means and checked to what extent the intra-subjects factors influence the dependent variables.

Expected results. Improved shoulder strength, stability and functionality for the subjects on which the study is carried out.


Eligibility Criteria:
Inclusion Criteria:

* Federated rugby players
* Male
* 18 to 45 years old
* Currently participating in regional competitions

Exclusion Criteria:

* Being treated with anti-inflammatory drugs
* Having suffered an upper limb injury in the month prior to the intervention
* Have undergone surgery for any shoulder pathology during the previous 12 months
* Who have suffered or suffer from a serious and / or metabolic disease
* That they have not signed the informed consent
LEV102 Topical Gel in Acquired Blepharoptosis

Phase 1/2a, multicenter, randomized, vehicle-controlled, double-masked, multiple-dose, parallel-group study conducted in adult subjects with acquired blepharoptosis.

This is a Phase 1/2a, multicenter, randomized, vehicle-controlled, double-masked, single-dose, parallel-group study conducted in adult subjects with acquired blepharoptosis. Subjects will receive a one-time application of randomized, double-masked IP. Approximately 30 subjects will be enrolled in this study. Eligible subjects will be randomized to 1 of the following 3 treatment groups in a 1:1:1 ratio and will receive a single dose of double-masked IP externally on the upper eyelid of both eyes (OU):

Eligibility Criteria:
Inclusion Criteria:

Subjects who meet all the following inclusion criteria will be eligible to participate in the study. Subjects must:

1. Be male or female subjects 25 years of age or older at the time of Screening (Visit 1)
2. Have complaints of aesthetically unacceptable upper eyelid position for both eyes making them desirous for elevation, or have complaints of superior visual field defects in both eyes that impact activities of daily living
3. Present with the following at Screening (Visit 1):

   a. At least one eye that meets both of the following criteria: i. Margin Reflex Distance 1 MRD1 ≤2 mm (no visible central pupillary light reflex defaults to 0) ii. Current corrected VA, using subject's own prescription eyeglasses, if applicable, in the qualifying eye(s) of +0.3 LogMAR (Logarithm of the Minimum Angle of Resolution) or better as assessed by ETDRS b. Demonstrate upper eyelid elevation ≥0.5 mm change from baseline in MRD1 in both eyes in response to a single drop of oxymetazoline 0.1% ophthalmic solution)to each eye at Screening
4. Women of Childbearing Potential must agree to use an approved method of birth control from the date they sign the informed consent form (ICF) until after the last study visit (Follow-Up Visit)
5. Be able to give informed consent and willing to comply with all study visits and examinations

Exclusion Criteria:

1. Have any other ocular pathology other than ptosis requiring treatment with topical prescription ophthalmic drops in either eye (e.g., glaucoma, dry eye)
2. Have narrow angles, glaucoma, intraocular pressure \>23 mmHg or diagnosis of ocular hypertension, cup-to-disc ratio of \>0.7, or history of any glaucoma eye surgery in either eye
3. Have any active ocular or peri-ocular infection; any history of recurrent or chronic infection or inflammation in either eye
4. Have a history of allergic reaction to the investigational drug or any of its components
5. Within 7 days of Screening (Visit 1), or anticipated use during the study, use of any systemic, intranasal, topical dermatologic, or ophthalmic α-adrenergic agonist (including brimonidine) or antagonist including nasal or ocular or oral decongestants including pseudoephedrine, oxymetazoline topical ophthalmic solution, oxymetazoline topical dermatologic cream
6. Subjects who are pregnant or breast-feeding
Descartes-25 in Relapsed/Refractory Multiple Myeloma

This is a Phase I/IIa dose-escalation study to evaluate the safety, tolerability, and preliminary efficacy of an allogeneic Mesenchymal Stem Cell (Descartes-25) product secreting a bispecific protein and other proteins in patients with Relapsed/Refractory Multiple Myeloma.


Eligibility Criteria:
Inclusion Criteria:

* 18 years and older'
* diagnosed with active R/RMM, who have failed 2 lines of treatment
* have measurable disease

Exclusion Criteria:

- Patients with active plasma cell leukemia
KT® in Patients with Cervical Spine Surgery

Aim of the study was to investigate the effect of Kinesio taping application on upper trapezius muscle after cervical spine surgery.

Patients will be randomly divided into three groups. The first group will receive conservative treatment and Kinesio Taping application. The second group will receive conservative treatment and the third group will receive only Kinesio taping application. The treatment procedure will continue for post-operatively three days and assessments will be done four times; before the surgery, post-operative 1st day, postoperative 3rd day and two weeks after surgery. Data will be recorded on patient assessment file and transferred to the computer. Data analysis will be performed with SPSS.22.

Eligibility Criteria:
Inclusion Criteria:

* To be voluntary participation in the study,
* Aged 25-75 years old,
* To be diagnosed with cervical disc herniation, cervical stenosis and cervical spondylolisthesis
* No mental problem, sensory or motor aphasia in order to understand and answer the evaluation questions correctly.

Exclusion Criteria:

* History of surgery,
* Allergic reaction to kinesio taping,
* Primary or metastatic neoplasm in cervical spine,
* History of different treatment for neck pain during the study period,
* Individuals with any congenital deformity in the spine,
* Having any rheumatologic, neurological and orthopedic disease.