cyrilzakka/clinical-trials huggingface dataset:
A Study to Assess the Efficacy of 3 Months of Latanoprost Treatment in Reducing the Intraocular Pressure in Patients With Ocular Hypertension or Open-angle Glaucoma

The purpose of this study is to evaluate the effect of latanoprost on intraocular pressure reduction in patients with ocular hypertension or open-angle glaucoma.


Eligibility Criteria:
Inclusion Criteria:

* A patient with an IOP greater than or equal to 20 mmHg related to unilateral or bilateral OH or OAG (primary open angle glaucoma, pseudo-exfoliative glaucoma, and pigmentary glaucoma), after a visual field exam
* Naive patients (i.e. never having been treated) and requiring treatment initiation

Exclusion Criteria:

* A patient with OH or OAG currently on treatment
* A patient with OH or OAG previously treated (regardless of the date treatment was discontinued)
* A patient with traumatic, inflammatory, or neovascular glaucoma
Remote Ischemic Preconditioning in Cardiac Surgery

Aim of the work :

Evaluation of the role of Remote Ischemic Preconditioning (RIP) on liver function in patients undergoing on-pump cardiac surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Being candidate for on-pump cardiac surgery.
2. Willing to participate in the study
3. Ages eligible for the study: 18 to 70 years.
4. Gender eligible for the study : both

Exclusion Criteria:

1. Patient refusal.
2. Known cause of possible liver function disturbances that includes right heart failure, acute inflammation of gallbladder or any other complication of gallstone disease.
3. Active viral and non viral hepatitis.
4. Pregnant women.
5. History of peripheral nerve disease or peripheral vascular disease of the extremities
A Study of LY900014 and Insulin Degludec in Participants With Type 1 Diabetes

In this study, participants with type 1 diabetes (T1D) will take the study drug LY900014 and insulin degludec. The reason for this study is to evaluate the amount of time with glucose values within target range.


Eligibility Criteria:
Inclusion Criteria:

* Participants must have type 1 diabetes and have been treated with insulin therapy for at least 1 year
* Participants must be using Continuous Glucose Monitoring (CGM) with total CGM use ≥ 2 months in the prior 6 months
* Participants must have been on the same type of short acting insulin (Humalog U-100, Novolog, Admelog, or Apidra) for at least 30 days prior to screening
* Participants must have been treated with long-acting insulin degludec U-100 for at least 30 days prior to screening

Exclusion Criteria:

* Participants must not have had more than 1 emergency room visit or hospitalization due to poor glucose control within 6 months before screening
* Participants must not have had more than 1 episode of severe hypoglycemia within the last 90 days prior to screening
* Participants must not be taking certain diabetes medications that are not allowed for study participation
Effects of an Infant Formula and follow-on Formula Containing Bio-active Ingredients on Growth, Tolerance and Infections

In this clinical trial, the growth (weight for age), product tolerance (product intake, comfort) and infection-related symptoms of healthy infants consuming an IF and FOF containing bio-active ingredients will be evaluated and compared to a group of infants consuming a standard IF and FOF

In this clinical trial, the growth (weight for age), product tolerance (product intake, comfort) and infection-related symptoms of healthy infants consuming an IF and FOF containing bio-active ingredients will be evaluated and compared to a group of infants consuming a standard IF and FOF, until the age of 1y. 456 healthy term infants who are exclusively formula-fed will be included \<2mo of age.

Eligibility Criteria:
Inclusion Criteria:

* Full-term infants
* Healthy birthweight: 2500 g ≤ birthweight ≤ 4200 g
* Boys and girls
* Apparently healthy at birth and screening
* Weight-for-age Z-score (WAZ) at screening within the normal range according to WHO Child Growth Standards
* Age at enrolment: ≤60 days of age
* If age at inclusion ≤1 month: infants exclusively formula fed for at least 5 days prior to inclusion
* If 1 month \< age at inclusion ≤ 2 months: infants exclusively formula fed since 1 month old2
* Being available for follow up until the age of 12 months
* Written informed consent from parent(s) and/or legal guardian(s) aged ≥18 years

Exclusion Criteria:

* Severe acquired or congenital diseases, mental or physical disorders, including cow's milk protein allergy (CMA), lactose intolerance and diagnosed medical conditions that are known to affect study outcomes (e.g. functional gastro-intestinal disorders (FGID))
* Incapability of parents to comply with the study protocol
* Illiterate parents (i.e. not able to read and write in local language)
* Participation in another clinical trial
* Unwillingness to accept the formula supplied by the study as the only formula for their child until the age of 12 months
* Infants fed a special diet other than standard cow's or goat's milk based (non-hydrolyzed) infant formula prior to inclusion
Double Blind, Randomized Trial of Bosentan for Sarcoidosis Associated Pulmonary Hypertension

Patients with advanced sarcoidosis often develop pulmonary hypertension. Pulmonary hypertension is a condition where the right side of the heart has to push the blood though the lungs at a higher pressure than normal. Since this pressure is higher, it is harder for the heart to pump the blood through the lungs to the left side of the body. If the blood can not get through the lungs, it can not get pumped through the rest of the body. This leads to weakness and shortness of breath. This type of hypertension does not usually respond to regular blood pressure medicines. The purpose of this study is to determine if bosentan (Tracleer) will help sarcoidosis associated pulmonary hypertension.

Patients will be randomized in 2:1 manner to receive either bosentan or placebo for 16 weeks. After 16 weeks, there will be an additional 32 weeks of an open label extension.

Eligibility Criteria:
Inclusion Criteria:

* Patients with known sarcoidosis 21.
* Age 18 or greater
* Patients with documented pulmonary hypertension with a PA mean \> 25 mm Hg as measured by cardiac catheterization within six months of entry into the study. Pulmonary artery occluding pressure and or left ventricular end diastolic pressure must be less than 15 mm Hg.
* Patients with WHO class II or III
* Six minute walk distance of between 100 to 500 meters
* Patients on stable immunotherapy for their sarcoidosis, including prednisone, methotrexate, azathioprine, hydroxychloroquine, cyclophosphamide, thalidomide, and/or infliximab
* Patients able to provide written consent

Exclusion Criteria:

* Patients on pulmonary vasodilator drugs (flolan, remodulin, bosentan, sildenafil) n the prior 28 days. Patients on stable dose of calcium channel blocker for more than 1 month prior to right heart catheterization can be continued on the calcium channel blocker.
* Patients with severe airway obstruction as defined by FEV1/FVC of less than 35%
* Patients with World Health Organization (WHO) class IV status.
* Patients who are pregnant or breast feeding
* Patients with significant left ventricular dysfunction with a left ventricular ejection fraction of less than 35%
* Cardiac index \< 2.0 liters and/or right atrial pressure \>15 mm Hg
* Significant liver dysfunction not due to sarcoidosis.
* Patients with severe other organ disease felt by investigators to impact on survival during the course of the study.
* Patients unable to perform the 6 minute walk study
Staging System in Amyotrophic Lateral Sclerosis

Recently two staging systems have been proposed for amyotrophic lateral sclerosis (ALS), based on clinical milestones The King's college clinical staging system (1) and ALS Milano-Torino Staging (ALS-MITOS) (2). Further research to validate and develop an accurate staging system in different populations will improve our understanding of its pathogenesis, disease activity and progression.

General objective : To validate the two previously proposed staging system and to test the interest of considering Neurofilament biomarkers in these systems.

Specific objectives: 1) To validate the two classification systems in an independent cohort of patients with ALS followed-up in the ALS expert center of Limoges (France) 2) To assess the interest of Nf biomarkers to predict neurological decline

Amyotrophic lateral sclerosis (ALS) is a rare, fatal neurodegenerative disease of the human motor system. Recently two new staging systems have been proposed for ALS, based on clinical milestones related also to the spreading pattern of the disease (1,2). Furthermore, biomarker development is still an essential component of future therapeutic development in ALS. Thus, it is also important to acknowledge the value of biomarker research in supporting or revealing fundamental pathophysiological mechanisms in ALS.

The proposed staging systems: have been recently tested in two independent cohorts (3,4) with results that were not fully consistent (ii) did not considered the potential value of biomarkers.

Eligibility Criteria:
Inclusion Criteria:

* ALS cases recruited for retrospectively (between) 2007 to 2016 for the retrospective cohort
* ALS cases recruited for prospectively by the ALS expert center of Limoges for one year.

Exclusion Criteria:

* Previous neurosurgical operations
* A recent history of neurotrauma
* Peripheral neuropathies
* ALS/frontotemporal dementia (ALS/FTD)
A Study in Maintenance Kidney Transplant Recipients Following Conversion to Nulojix® (Belatacept)-Based

The primary purpose is to assess the benefits and risks of changing from Cyclosporine or Tacrolimus to Belatacept between 6-60 months after kidney transplant.


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Men and women, ages 18-75 inclusive
* Adult recipients of a renal allograft from a living donor or a deceased donor between 6-60 months prior to enrollment
* Receiving a stable (≥1 month) regimen of Calcineurin inhibitor (CNI) \[Cyclosporine A (CsA) or Tacrolimus (TAC)\] with Mycophenolate mofetil (MMF) or Enteric Coated Mycophenolate Sodium (EC-MPS)/Mycophenolic acid (MPA), and corticosteroids
* Stable renal function for 12 weeks prior to enrollment without new onset proteinuria
* Calculated glomerular filtration rate (cGFR) ≥30 and ≤75 mL/min/1.73 m2 \[Modification of Diet in Renal Disease study (MDRD) 4-formula\]

Exclusion Criteria:

* Recipients with Epstein-Barr virus (EBV) serostatus negative or unknown
* History of acute rejection (AR) within 3 months prior to enrollment
* History of antibody mediated rejection
* Positive T-cell lymphocytotoxic cross match
* Proteinuria \>1 g/day or \>0.5 g/day if diabetic
Patient Perceptions and Willingness to Enroll in Clinical Trials

The objective of our study is to determine which factors affect willingness to participate in gynecologic oncology clinical trials. Women with a diagnosis of gynecologic malignancy will be approached to complete a survey assessing willingness to participate in clinical trials. The validated Attitudes and Randomized Trials Questionnaire (ARTQ) will be used to assess willingness to participate.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of gynecologic malignancy
* English or Spanish literate

Exclusion Criteria:

* Prior enrollment in a clinical trial
* Currently pregnant
* Currently incarcerated
Breaking Sitting and Metabolic Health in Sedentary Lean Adults

The purpose of this project is to investigate the effects of breaking up prolonged sitting on postprandial metabolic responses, gut hormones secretion and energy balance in sedentary lean adults.

Two trials are included - Prolonged sitting and Breaking sitting.

In the Prolonged sitting trial, after consuming breakfast, participants sat on a chair for 180 min. After 180 min, lunch was provided. After finishing lunch, participants sat on a chair for another 120 min. In the Breaking sitting trial, after consuming breakfast, participants walked 2 min on a treadmill every 20 minutes for the following 180 min. For the remainder of the time participants sat on the chair. After 180 min, lunch was provided. After finishing lunch, participants continued 2 min of walking every 20 min for the following 120 min. Blood samples were collected in a regular pattern throughout the trials. Energy balance (e.g., energy intake and spontaneous physical activity) was assessed using food diary and an accelerometer until midnight in the trial days once participants left laboratory.

Eligibility Criteria:
Inclusion Criteria:

* Physical inactive males and females
* Aged between 20 and 45 years
* Lean healthy (waist circumference less than 90 cm for males and 80 cm for females)
* Weight stable for more than 3 months (no change in weight +/- 3%)
* Non-smoker
* Able to walk comfortably on a treadmill

Exclusion Criteria:

* Personal history of/existing diabetes, cardiovascular disease, metabolic disease or dyslipidaemia
* Waist circumference \> 90 cm for male and \> 80 cm for female
* Taking medications that may influence lipid or carbohydrate metabolism or immune system function
* Unable to take part in exercise for any reason (e.g., injury or disability) or a positive response to any questions on the Physical Activity Readiness questionnaire (PAR-Q)
Window Trial 5-aza in HNSCC, T-tare

The purpose of this study is to assess the activity of 5-azacitidine in patients with Human Papilloma Virus (HPV)-positive and HPV- negative head and neck squamous cell carcinoma (HNSCC). The response activity will be determined by analyzing your tumor tissue prior to and after treatment with 5-azacitidine. Preliminary studies in mice bearing human head and neck cancers or head and neck cancer cells cultured in laboratories suggest that treatment with 5-azacitidine increases changes in cancer cells that lead to their death. This study is designed to determine if similar changes occur in cancer cells of patients with head and neck cancer.

The study also aims to determine the amount of a specific type of protein, p53 before and after treatment. Research has shown that the p53 protein is associated with anti-tumor activity.

Finally, this study is measuring the amount of a specific type of protein called interferon in your tumor tissue. Interferons are proteins made and released by the body in response to pathogens (disease causing agents) such as viruses, bacteria, or tumor cells. Interferons allow for communication between cells to trigger the protective defenses of the immune system that remove pathogens (disease causing agents) or tumors.

Primary Objectives:

The primary objectives of this study are:

• to determine the proportion of HPV-positive patients in whom 5-azacytidine increases APOBEC RNA expression.

Secondary Objectives

The secondary objectives of this study are:

* to investigate response (proliferation, apoptosis), as well as reactivation of IFN pathways in patients treated with 5-azacitadine for HPV-positive and HPV-negative HNSCC.
* to investigate the clinical activity of 5-azacitadine in patients with HPV-positive and HPV-negative HNSCC.
* to investigate the safety of 5-azacitadine in patients with HPV-positive and HPV-negative HNSCC

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed p16 or HPV PCR positive HNSCC with surgically resectable disease
2. Age ≥18 years of age.
3. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1 or 2
4. ANC greater than or equal to 1500, Hb greater than or equal to 8, platelet count greater than or equal to 100,000

Exclusion Criteria:

1. AST or ALT greater than 2.5 x ULN
2. Known brain metastases
3. Women must not be pregnant or breastfeeding
4. Known allergy to 5-azacitadine
5. Patients receiving any other investigational agents within 4 weeks of starting the study
A Study of JR-141 in Patients With Mucopolysaccharidosis II

A Phase II/ III multicenter, open-label, single-group, designed to evaluate the efficacy and safety of study drug for the treatment of the MPS II.


Eligibility Criteria:
Inclusion Criteria:

1. Capable of providing written consent by himself (not mandatory for those aged under 20 years at the time of informed consent process, or those who is impossible to obtain consent from the patient himself due to intellectual disabilities associated with MPS II.)
2. In the case of a patient who is under the age of 20 years or from whom it is not possible to obtain consent due to intellectual disabilities associated with MPS II, he may be included if written consent can be provided by legal representative (however, written consent should be obtained from the patient himself too, whenever possible)
3. Males with confirmed diagnosis of MPS II, based on deficient activity of iduronate-2-sulfatase (IDS) in leucocytes, plasma or fibroblasts and/or pathogenic mutations identified in the IDS gene, etc.
4. Naïve patients or patients who are receiving stable enzyme replacement therapy with Elaprase for more than 8 weeks before the observational period starts.

Exclusion Criteria:

1. Previous engrafted HSCT, excluding those who need enzyme replacement therapy even after HSCT.
2. Judged by the investigator or subinvestigator as being unable to undergo lumbar puncture, including those who have difficulties in taking position for lumbar puncture due to joint contracture or those who are likely experience difficulty breathing during the lumbar puncture process.
3. Judged by the investigator or subinvestigator to be ineligible to participate in the study due to a history of serious drug allergy or sensitivity.
4. Patients who have received other investigational product within 4 months before enrollment in the study.
5. Otherwise judged by the investigator or subinvestigator to be ineligible to participate in the study.
European Union Registry in Paediatric Chronic Kidney Disease Patients Looking at Safety and Usage Patterns of Darbepoetin Alfa

This European study observes paediatric patients with Chronic Kidney Disease using Darbepoetin Alfa to assess the drug's long term safety and profile the patterns of its use within this population.


Eligibility Criteria:
Inclusion Criteria:

* Anaemia attributed to Chronic Kidney Disease (CKD)
* Sixteen years of age or under
* Documented CKD as demonstrated by estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73m² (Schwartz equation) for ≥3 months if not on dialysis, or: Receiving dialysis
* Treatment with darbepoetin alfa
* Documented informed consent by a parent or authorised individual, if required, and assent by the patient if appropriate

Exclusion Criteria:

* Active malignancy or current chemotherapy or radiation therapy
* Investigator unlikely to be able to obtain adequate follow-up information, or participant will not be available for follow-up assessment
* Currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug study; subject receiving other investigational agents
The Teaspoon Study - Telefitting Spinal Cord Stimulation for Pain

Spinal cord stimulation modulates the nervous system to effectively block pain signals originating from the back and legs. Spinal cord stimulation has been shown to improve chronic pain, improve quality of life, and reduce disability. Unfortunately, spinal cord stimulation has a high trial failure rate and a high long-term failure rate. This study consists of a prospective cohort of patients clinically scheduled to undergo spinal cord stimulation for the treatment of chronic back pain or radiculopathy. Participants will undergo a structured optimization evaluating existing types of stimulation (tonic, burst, and multistim). Each participant will try out all types of available stimulation but be blinded to the type. Over the course of four months, each participant will evaluate each type of stimulation by reporting daily pain scores. Thompson sampling will be used to identify which setting produces the biggest improvement in pain and recommend it for future use. Participants will follow up routinely to collect laboratory, behavioral, and survey responses to test for the feasibility of obtaining data explaining pain phenotype.


Eligibility Criteria:
Inclusion Criteria:

* 22 years of age or older
* Scheduled to undergo spinal cord stimulation
* English speaker
* Baseline pain rating (NRS/VAS) \>=6

Exclusion Criteria:

* Scheduled for permanent implantation only without trial
* Presence of pacemakers or other neurostimulators
* Pregnant
* Inability to read or use smart phone
* Individuals who are unable to consent
* Employees or students of PI
* Prisoners
RCT Between UPP and Controls in Adult OSA

To compare the effect of uvulopalatoplasty with no treatment in treating adult OSA.

Two arms: the intervention group undergo uvulopalatoplasty one month after baseline polysomnography (PSG1) and a PSG2 6 months after surgery .

The control group perform PSG 1 and are then waiting 6 months, thereafter undergo PSG2, then surgery and PSG3 6 months after surgery. All patients are followed for four years with PSG. Patients fill in questionnaires at PSG sessions, and blood pressure control the morning after.

Eligibility Criteria:
Inclusion Criteria:

* AHI of 15 or more
* Friedmans stage I+II
* Tonsil size 0-1
* BMI\<34
* ESS värde \>7
* Failed treatment with CPAP and mandibular device

Exclusion Criteria:

* Severe cardiovascular or neurological disease
* ASA IV
* Not interested in surgical treatment
A Randomized, Blinded, Multicenter Study to Evaluate NASHA/Dx for the Treatment of Fecal Incontinence

The purpose of this study is to determine the effectiveness and safety of NASHA/Dx when used as an injectable bulking agent in the treatment of fecal incontinence. The study includes a 6-month blinded sham-controlled phase, followed by an open-label phase.

Subjects will be given up to 2 treatments of NASHA/Dx or sham and followed for 6 months from last treatment (ie, one retreatment is permitted at 1 month after the first injection) in the blinded phase of the study. At Month 6, the open phase of the study will begin and subjects on sham will be offered open-label treatment with NASHA/Dx.

Subjects who receive NASHA/Dx at the start of the blinded phase will be followed for up to 36 months from last treatment in the blinded phase. Subjects who receive sham at the start of the blinded phase and then receive open-label NASHA/Dx at Month 6 (start of the open phase) will be followed for another 24 months (equivalent to approximately 30 months from randomization) from last treatment in the open phase of the study.

Eligibility Criteria:
Inclusion Criteria:

* 18-75 years of age, male or female.
* Screening fecal incontinence severity score (CCFIS).
* Fecal incontinence episodes over a 14-day period.
* Failed conservative treatment for fecal incontinence.

Exclusion Criteria:

* Complete external sphincter disruption.
* Significant anorectal disease.
* Anorectal surgery within the last 12 months prior to the study.
* Active Inflammatory Bowel Disease (IBD).
* Immunodeficiency or receiving immunosuppressive therapy.
* Malignancies in remission for less than 2 years prior to the study.
* Bleeding disorders or receiving anticoagulant therapy.
* Chemotherapy within the last 12 months prior to the study.
* Prior Pelvic radiotherapy.
* Women who are pregnant or breast-feeding, or women of childbearing potential not practicing adequate contraception or planning to stop such contraception within the first year of the study.
* Women within one year post partum.
* Participation in any other clinical study within 3 month prior to the study.
* Hypersensitivity to hyaluronic acid containing products.
* Other severe conditions or in other ways unsuitable to participate according to investigator judgement.