cyrilzakka/clinical-trials huggingface dataset:
Artificial Tears, Tear Lipids and Tear Film Dynamics

Dry eye disease (DED) is pervasive with some reports estimating over 16 million adults diagnosed in the United States. Currently, artificial tears remain an integral part of managing dry eyes and are mainly used for symptomatic relief. Recent studies have shown there may be therapeutic benefits with regular use of lipid-based artificial tears to improve the structure of the tear film, which may improve tear film stability and provide relief of symptoms. In this study the investigators propose to compare effects on the tear lipid film and its dynamics between 3 lipid based artificial tears and a widely available non-lipid based artificial tear.

This is a prospective, double-masked, randomized, controlled, parallel-group trial designed to compare the impact of Systane Complete PF lipid-based artificial tears (the Treatment solution under study) on tear lipid layer thickness compared with a non-lipid Control solution, Refresh Relieva PF. Secondarily, the study will compare changes in tear lipid layer thickness, lipid layer uniformity, tear film thinning dynamics, and symptoms between the Treatment solution, the non-lipid Control solution, and 2 other available lipid-based solutions (Active Comparators: Refresh Optive Mega-3 PF and CVS Health Lubricant Eye Drop (PG 0.6%)). The study will include 4 clinic visits, and require 1 week of single-masked run-in with Systane Ultra PF (an over-the-counter non-lipid-based solution) followed by 3 months of study treatment dosing. All subjects will complete a screening interview, then an in-clinic baseline ocular health examination and study eligibility determination followed by dispensing of the Control solution to all subjects for 1 week of run-in. After that week, subjects will be randomized to 1 of the 4 artificial tear solutions and have an in-clinic ocular examination and dispense of the assigned solution to use for 3 months. An in-clinic follow-up examination is completed after 1 month of study solution use, followed by a phone interview at 2 months, and a final in-clinic examination at 3 months post-dispensing.

Eligibility Criteria:
Inclusion Criteria:

* Best Corrected Visual Acuity of 20/30 or better;
* Experiencing Dry Eye symptoms (baseline OSDI score \>= 13);

Exclusion Criteria:

* Currently experiencing active ocular inflammation or infection;
* Currently using topical eye medication (not including over-the-counter eyedrops);
* Having systemic health conditions or using prescription medications (including but not limited to isotretinoin derivatives) that could alter tear film physiology;
* Having a history of severe ocular trauma, ocular surgery, or diabetes;
* Being pregnant or breast feeding;
* Being a current contact lens wearer;
* Currently having a condition or being in a situation which, in the examiner's opinion, may put the subject at significant risk, may confound the study results, or may otherwise significantly interfere with their participation in the study;
Study Evaluating Prevenar Vaccine in Healthy Infants

To determine the immunogenicity of Prevenar in infants immunized at 2, 4 and 6 months of age. To determine the antibody responses to the seven pneumococcal vaccine serotypes one month after second dose and determine the safety of Prevenar in infants immunized at 2,4 and 6 months of age.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female children 2 months of age (42 to 100 days) in good health.
* An informed consent must be signed by a parent or legal guardian following a detailed explanation of participation in the study.
* Infants whose parent(s)/guardian(s) will be available for the entire study period.

Exclusion Criteria:

* Hypersensitivity to any component of the vaccine, including diphtheria toxoid
* Infants with thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection
* Infants with known or suspected impairment of immunologic functions including HIV or those receiving immunosuppressive therapy.

Other exclusions apply.
Knee vs. Ankle Training on Knee Mechanics After ACLR

This study will be conducted to investigate if there is any difference between starting rehabilitation program after ACL reconstruction with knee joint training followed by ankle joint training and starting it with ankle joint training followed by knee joint training (crossover effect) on gait parameters of the knee joint.


Eligibility Criteria:
Inclusion Criteria:

* ACL reconstruction with a hamstring tendon autograft participated in this study.
* Score 7 on Tegner activity scale.

Exclusion Criteria:

* Patients with bilateral knee injury
* History of surgery or traumatic injury to the uninvolved lower extremity or to the hip or ankle of the involved lower extremity
* History of ACL reconstruction on the ipsilateral side and other knee ligament injuries requiring surgery.
Minocycline for Helicobacter Pylori Rescue Treatment

Current guidelines have recommended classical bismuth-containing quadruple therapy including proton-pump inhibitor, bismuth, tetracycline, metronidazole as the empirical rescue therapy. However, tetracycline is clinically unavailable in China and the high frequency of adverse events of bismuth quadruple therapy often result in poor compliance, which limited the applicability of this recommendation. We previously showed that the efficacy of bismuth-containing quadruple therapy with minocycline and metronidazole was not inferior to classical bismuth quadruple therapy for refractory H. pylori infection, though also accompanied with high occurrence of adverse events.This study aimed to evaluate the efficacy and tolerability of four different regimens with minocycline and metronidazole compared to classical bismuth quadruple therapy for H. pylori rescue treatment in a real-world setting.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed H. pylori infection and with previous treatment failure

Exclusion Criteria:

* subjects naive to H. pylori treatment,
* history of gastrectomy
* pregnant or lactating women
* severe systemic diseases or malignancy
* administration of antibiotics, bismuth, antisecretory drugs, or Chinese herb medicine in the preceding 12 weeks
A Phase 4 Study With Tamsulosin OCAS to Assess Nighttime Voiding.

Randomized, double-blind, placebo-controlled study with two treatment arms (Tamsulosin OCAS 0.4 mg \& placebo). The study comprises a 2-week placebo run-in followed by a 12-week treatment period.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed as having LUTS associated with BPH
* On average, at least 2 voids per night over the last week
* A maximum of 4 hours of undisturbed sleep expected per night (night time is defined as the time from going to bed with the purpose of sleeping until waking up with the purpose of getting up)

Exclusion Criteria:

* Subject is currently taking diuretics
* Subjects who work shift hours and whose hours of work include any time between 23.00 and 06.00h
Phase I/Ib Trial of LSZ102 Single Agent or LSZ102 + LEE011 or LSZ102 + BYL719 in ER+ Breast Cancers

To characterize the safety and tolerability, identify recommended doses and regimens for future studies, pharmacokinetics (PK), pharmacodynamics (PD) and anti-tumor activity of LSZ102 as a single agent and in combination with either LEE011 or BYL719 in adult patients with locally advanced or metastatic ER+ breast cancer who have progressed after endocrine therapy.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent must be obtained prior to any procedures
* Histologically and/or cytologically confirmed diagnosis of ER+/HER2- breast cancer
* Advanced or metastatic breast cancer
* Must be able to swallow tablets and capsules

Exclusion Criteria:

* Symptomatic CNS metastases
* Patients whose laboratory values do not meet protocol criteria
* Clinically significant cardiac disease
* Impaired gastrointestinal function (GI) or GI disease that may significantly alter the absorption of oral medications

Other protocol defined inclusion/exclusion criteria may apply.
PulseHaler Drug Deposition Study in Chronic Obstructive Pulmonary Disease Patients

This study is aimed at finding the effect of PulseHaler™ with Albuterol on Lung Deposition of Aerosol and on Pulmonary Functions in COPD Patients


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Chronic Obstructive Pulmonary Disease (COPD), established for at least 1 year
* Post-bronchodilator FEV1/FVC \< 0.7
* Post-bronchodilator FEV1 in the range 30% - 70% predicted
* Age: 40 years or older
* Patient signed the informed consent form

Exclusion Criteria:

* Pneumothorax in the past, per anamnesis.
* Women at the age of fertility, who are pregnant, or plan pregnancy, or do not use contraceptive.
* Severe cardiac disease, e.g., Congestive Heart Failure (CHF) grade 3 or higher
* Coronary Artery Bypass Graft (CABG) or Acute Myocardial Infarction (MI) within last 3 months
* Other severe systemic disease
* Non-cooperative or non-compliant patient
This is a Study to Evaluate a Pre-confectioned Plantar Insole for the Treatment of Plantar Heel Pain

Patients affected by plantar heel pain will be asked to use a pre-confectioned plantar insole for one year.

The aim of the study is to assess if the insole under study allows the patient to reach a better mobility and a faster return to the normal everyday life.


Eligibility Criteria:
Inclusion Criteria:

Male and female adults

* Age ranging 18 to 70 years
* Patients with a history of at least 6 months of plantar fasciitis resistant to other conventional therapies
* Willingness and ability to participate in the trial
* Informed Consent signed by the subject

Exclusion Criteria:

* Diabetes mellitus not controlled pharmacologically
* Rheumatoid arthritis
* Previous foot surgery
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, general physical problem of the participant, etc.
Efficacy and Safety of Valsartan and Amlodipine (± HCTZ) in Adults With Moderate, Inadequately Controlled Hypertension

This study will evaluate the efficacy and safety of valsartan and amlodipine in fixed dose combination in adults with moderate, inadequately controlled hypertension. There was an optional study extension for eligible patients who wanted to participate that contains the triple therapy (ie, hydrochlorothiazide+ amlodipine/valsartan).

Title of study extension: An open-label, multicenter extension to evaluate the efficacy and tolerability of a 4 week therapy with hydrochlorothiazide 12.5 mg plus amlodipine 10 mg/valsartan 160 mg in hypertensive patients not adequately responding to a 4 week therapy each with the combinations of olmesartan 20 mg plus amlodipine 10 mg followed by amlodipine 10 mg/valsartan 160 mg

Eligibility Criteria:
Inclusion Criteria for Core study:

* Male or female patients (\>=18 years)
* Females must be either post-menopausal for one year, surgically sterile or using effective contraceptive methods
* Patients with essential hypertension (diastolic blood pressure \>=100 mmHg and \<110 mmHg)

Inclusion Criteria for Extension:

- Patients had to have a msSBP \>= 140 mmHg and/or msDBP \>= 90 mmHg at week 8 ie, end of core study.

Exclusion Criteria for Core study:

* Severe hypertension (diastolic blood pressure \>=110 mmHg or systolic blood pressure \>= 180 mmHg)
* Pregnant or nursing women
* Treated hypertensive patients with controlled hypertension under current therapy
* A history of cardiovascular disease, including angina pectoris, myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, transient ischemic attack, stroke, and heart failure NYHA II - IV

Exclusion Criteria for Extension:

* prematurely discontinued the core study
* failed to comply with the core study protocol

Other protocol-defined inclusion/exclusion criteria applied to the study.
Intrathecal Morphine in Robot-assisted Prostatectomy

This study will investigate the efficacy and safety of intrathecal morphine for the patients undergoing robot-assisted prostatectomy

Prostatectomy is the treatment of choice for prostate cancer. The robot-assisted prostatectomy is becoming the most popular surgical method for prostate cancer. The small incision after robot-assisted prostatectomy is thought to reduce the postoperative pain. There is few investigations for the strategy to reduce the postoperative pain of robot-assisted prostatectomy.

The intrathecal morphine injection is known to reduce postoperative pain for surgeries like hepatectomy, myomectomy and open prostatectomy. This method, however, is not yet studied for the robot-assisted prostatectomy. This study will investigate the efficacy and safety of intrathecal morphine for the patients undergoing robot-assisted prostatectomy.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for the open nephrectomy

Exclusion Criteria:

* Patients with renal insufficiency
* Patients with coagulopathy
* History of any neurologic disorder
* History of recent infection in 2 weeks
* History of drug abuse
* Patients who cannot understand the usage of th intravenous patient-controlled analgesia
* Patients using opioids due to the chronic pain
Chart Review: Unresectable/Metastatic Cholangiocarcinoma Treated With Irinotecan, Capecitabine and Celecoxib

Chart Review on Patients with unresectable/metastatic cholangiocarcinoma treated in the UNM Cancer Center with a combination of irinotecan, capecitabine and celecoxib.

As above.

Eligibility Criteria:
Inclusion Criteria:

* Patients with unresectable/metastatic cholangiocarcinoma treated in the UNM Cancer Center with a combination of irinotecan, capecitabine and celecoxib.

Exclusion Criteria:

* Not specified.
Evaluation of a Novel Optical Microscope with a Deep Depth of Field (DeepDOF) to Provide Histologic-quality Images on Cervical Biopsies and Loop Electrosurgical Excision Procedure (LEEP) Specimens At the Point-of-care

All patients will be enrolled in Mozambique and Brazil. They will provide informed consent to use their cervical biopsy and/or LEEP specimens for imaging with DeepDOF prior to sending for standard of care processing and interpretation.

Primary Objectives:

1. Evaluate the diagnostic performance of the DeepDOF digital histopathology platform compared with standard histopathology in cervical biopsies and/or LEEP specimens.
2. Compare performance characteristics between WLWH and HIV-negative women.

Secondary Objectives:

1. Evaluate the ability of pathologists to provide a diagnostic evaluation of cervical biopsies and LEEP margins using digital DeepDOF images.
2. Develop DeepDOF algorithms for automated diagnostic evaluation of cervical biopsies and LEEP margins.

Eligibility Criteria:
Inclusion Criteria:

1. Women aged 25 - 49 years
2. women undergoing cervical biopsy and/or LEEP
3. Women who are not pregnant and with a negative pregnancy test (within 3 days of enrollment)
4. Willing and capable of providing informed consent

Exclusion Criteria:

1. Women under 25 or over 49 years of age
2. Women not undergoing cervical biopsy or LEEP
3. Women who are pregnant
A Study Evaluating Implementation Strategies for the Delivery of Cabotegravir in Low and High-Volume PrEP Site in the United States

This is a two-arm study evaluating the impact of two implementation strategy conditions, dynamic implementation and routine implementation on the feasibility of delivering of Cabotegravir PrEP in low and high-volume PrEP sites in the United States for men who have sex with men (MSM) and Transgender men ≥ 18 years of age. There are two types of participants in the study. Patient Study Participants (PSPs) will refer to individuals who are enrolled in the study and who will receive commercially available Cabotegravir PrEP via prescription from the PrEP provider at the corresponding site. Staff Study Participants (SSPs) will refer to site staff who are involved in administrative and clinical aspects of offering and administering PrEP to PSPs and will participate in the staff study assessments. PSPs who choose to opt for 1-month oral lead-in (OLI) will receive cabotegravir tablets for PrEP at Month 1 followed by APPRETUDE intramuscular (IM) injections on Month 2, 3 and every two months thereafter up to Month 13. PSPs who opt for Direct to injections (DTI) will receive APPRETUDE IM injections on Month 1, 2 and every two months thereafter up to Month 12. Month 6/7 refers to Month 6 (DTI)/ Month 7 (OLI). Month 12/13 refers to Month 12 (DTI)/ Month 13 (OLI).


Eligibility Criteria:
Inclusion Criteria:

* Participant must be ≥ 18 years of age inclusive, at the time of signing the informed consent.
* No prior history of receiving CAB PrEP
* HIV negative test result at screening
* Capable of giving signed informed consent form

Exclusion Criteria:

* HIV indeterminate or positive test result during screening and prior to initiation of CAB PrEP
* A participant of concurrent interventional clinical or implementation science study at any time during the study
Outcome of Patients With Thoraco-abdominal Injury and Stress-induced Hyperglycemia or Diabetic Hyperglycemia

This study aimed to measure the effects of SIH and DH on the mortality outcomes of the adult patients with moderate to severe thoracoabdominal injury

Because the pathophysiologic response of the patients with a thoracoabdominal injury is different from those who had a traumatic brain injury, this study aimed to measure the effects of hyperglycemia induced by stress or by diabetes on the outcomes of patients with thoracoabdominal injuries in comparison with those who had non-diabetic normoglycemia (NDN). The primary study hypothesis stated that, following thoracoabdominal injuries, the patients with SIH had a worse outcome than patients with DH. The primary outcome was mortality rate of these patients.

Eligibility Criteria:
Inclusion Criteria:

* adult patients with moderate to severe thoracoabdominal injuries

Exclusion Criteria:

* patients with a thoracic and abdominal abbreviated injury scale (AIS) \< 3
* patients who had polytrauma which was defined as there was additional AIS scores ≥ 3 points in other regions of the body
* patients less than 20 years old
* patients who had sustained a burn injury
Hepatitis A Vaccine, Inactivated and Measles, Mumps, Rubella and Varicella Virus Vaccine Live Safety Study (V251-066)(COMPLETED)

Two doses each of Hepatitis A Vaccine, Inactivated and Measles, Mumps, Rubella and Varicella \[Oka/Merck\] Virus Vaccine Live will be given concomitantly or non-concomitantly. Safety data will be collected following each vaccination.


Eligibility Criteria:
Inclusion Criteria:

* Negative clinical history of hepatitis A, measles, mumps, rubella, varicella (chickenpox), and/or zoster
* No other vaccinations scheduled to be administered at the time of the first or second doses of VAQTA(TM) and ProQuad(TM)

Exclusion Criteria:

* Previously vaccinated with any hepatitis A vaccine, measles, mumps, rubella, and/or varicella vaccine either alone or in any combination
* History of allergy to any vaccine component
* History of seizure disorder
* Immunosuppressed including congenial and acquired conditions and immunosuppressive therapy
* Known severe thrombocytopenia or any other coagulation disorder that would contraindicate intramuscular injections
* Recent (\<72 hours) febrile illness (\>100.3 degrees F \[\>37.9 degrees C\] oral equivalent) prior to study vaccination.
Study of the Efficacy of Human Recombinant Factor VIII (Kogenate FS) Reconstituted in Pegylated Liposomes.

Primary efficacy endpoint: To study whether there is a difference in the length of the bleeding free periods between infusion of FVIII that is reconstituted with 22.1, 12.6, or 4.2 mg of pegylated liposomes per kg bwt compared with standard formulation.

Safety endpoint: To study the safety and tolerability of Kogenate FS reconstituted with Pegylated liposomes

Each subject will receive treatment for three bleeding episodes ("wash-in", on demand injections) followed by a minimum 4 day wash-out. Following this each subject will be randomized to a specific treatment order. Each order consists of four identical blocks. In each block the following three injections will be given: 1 One prophylactic treatment (randomized solution for dissolution) 2 and 3. Two standard on-demand treatments for a spontaneous bleeding episode (standard Kogenate FS). Each block will be followed by a four day wash-out. In total each subject should receive 3+4x3=15 injections. It is estimated that each subject will be in the study for about 4 months. A treatment for a spontaneous bleeding episode may require more than one infusion.

Eligibility Criteria:
Inclusion Criteria:

* Between 18 and 60 years of age
* Severe haemophilia A (≤ 1% of baseline Factor VIII activity)
* At least 250 treatment cumulative exposure-days (CEDs) to previous products
* At least 25 cumulative exposure-days (CEDs) to previous products during one year prior to study start
* If HIV positive, CD4 lymphocytes ≥ 400/µl
* Subjects on demand treatment, and with a minimum bleeding/treatment pattern of a four episodes per month, evenly distributed within each month, during the three month preceding study start
* Subjects who have given their written informed consent.

Exclusion Criteria:

* Inhibitors or history of inhibitors
* History of adverse reactions related to Factor VIII
* Platelet count \<90,000 /µl
* Subjects on prophylaxis treatment
* Subjects with concomitant debilitating disease (e.g. cancer, non-controlled diabetes, heart insufficiency, renal failure)
* Subjects with known sensitivity to blood products
* Subjects who have participated in another Ethical Committee approved Clinical Trial (including medical device studies) within the past 30 days
* Subjects with a weight over 86 kg or below 50 kg
* Subjects who do not understand or are not willing to comply with the requirement of the study protocol
* Subjects who cannot differentiate a bleeding episode from other causes of joint pain
Relationship Between Gross Motor Coordination and Balance in Children With Spastic Cerebral Palsy

This study aims to determine if there is a connection between gross motor coordination and balance in children with spastic cerebral palsy. Since these children often struggle with balance and other motor skills, researchers hypothesize that there is no link between the two abilities.

PURPOSE:

To examine the relationship between the gross motor coordination and balance in children with spastic cerebral palsy.

BACKGROUND:

Motor coordination is required for the effective acquisition of movements and effortless performance. Gross motor coordination involves numerous skills, including balance, bilateral movement, agility, and speed. Children with cerebral palsy exhibit a deterioration in gross motor coordination ability.

The lack of postural control in children with cerebral palsy impairs functional balance. According to studies, children with cerebral palsy have poorer static and dynamic balance responses than typically developing children.

HYPOTHESES:

- There is no relationship between gross motor coordination and balance in children with spastic cerebral palsy.

RESEARCH QUESTION:

- Is there a relationship between gross motor coordination and balance in children with spastic cerebral palsy.

Eligibility Criteria:
Inclusion Criteria:

1. They were scored Level I on the Gross Motor Function Classification System (GMFCS).
2. The subjects' age was from five to eleven years.
3. They were at least 1-meter-tall and not less 20 Kg.
4. They had to comprehend verbal commands.
5. They were score 1 to 1+ based on Modified Ashworth' Scale.

Exclusion Criteria:

1. Contracture, deformity and/or tightness in upper or lower limbs.
2. Botulinum toxin in the last year.
3. Recent fracture.
4. Vertigo or dizziness.
5. Epilepsy.
6. Osteoporosis.
7. Recent operation in the six months at least (according to the type of operation).