cyrilzakka/clinical-trials huggingface dataset:
Trial to Compare the Effects of Either Telmisartan (40-80 mg PO Once Daily) or Ramipril (5-10 mg PO Once Daily) on Renal Endothelial Dysfunction in Hypertensive Patients With Type 2 Diabetes

The primary objective is to evaluate the effect of 9 weeks treatment with either telmisartan or ramipril on NO bioavailability in the renal vasculature, measured as renal plasma flow (RPF) in response to NG-monomethyl-L-arginine (LNMMA) infusion.

This study was designed as a randomised, double-blind, double-dummy, parallel group in hypertensive patients with type 2 diabetes and normo- or microalbuminuria over a treatment period of 9 weeks.

After a 4 week Run-in period, patients will be randomised to one of the treatment groups and receive either Telmisartan 40 - 80 mg or Ramipril 5 - 10 mg. The treatment regimen is a forced titration with the lower dose given for 3 weeks and the higher dose given for the rest of the treatment period summing up to 9 weeks of treatment. During the treatment period, 3 visits to the investigator will be scheduled in order to control blood pressure, renal function parameters and safety. In addition, parameters of endothelial function in the renal vasculature, based on a nephrological clearance investigation and a provocation with L-NMMA will be measured at baseline and after 9 weeks of treatment.

Study Hypothesis:

Due to the exploratory nature of the trial, the primary objective to evaluate the effect on RPF in response to L-NMMA infusion at baseline and after 9 weeks of therapy with either telmisartan 80 mg or ramipril 10 mg was not planned to be addressed by a test of prespecified hypotheses.

Comparison(s):

The change in RPF from baseline (Visit 4) to the end of treatment (Visit 7) in response to L-NMMA infusion was to be calculated as the change from the pre L-NMMA infusion (S1) to the end of the L-NMMA infusion (S2). A comparison of treatment groups was to be made using an analysis of covariance (ANCOVA) with pooled centre and treatment included as main effects and RPF (in response to L NMMA infusion) at baseline as a covariate. The treatment group difference, adjusted for the other factors in the model, was to be presented with a corresponding 95% confidence interval (CI) and a test of statistical significance. The model was also to be used to provide analysis results for the within treatment group changes.

Eligibility Criteria:
Inclusion Criteria:

* Hypertensive patients aged 30-80 years with type 2 diabetes, normo- or microalbuminuria, GFR \> 80 mL/min (Cockroft-Gault)

Exclusion Criteria: None
Pilot Study: Intraoperative Clonidine and Postoperative Behaviour

Children who are upset during induction of general anaesthesia are frequently distressed postoperatively and are more likely to demonstrate negative behaviour changes.

This pilot study is a randomised controlled study of clonidine vs placebo during anaesthesia to identify whether postoperative behavioural disturbance may be minimised.


Eligibility Criteria:
Inclusion Criteria:

* age 2 to 10 years inclusive
* healthy (ASA 1 or 2)

Exclusion Criteria:

* inability of parents to understand english
Safety and Efficacy Study of Guaifenesin and Pseudoephedrine for Symptomatic Therapy to Treat Acute RTI

The purpose of this study is to determine if treatment with Mucinex D lowers the use of antibiotics in the treatment of upper respiratory infection when compared to placebo


Eligibility Criteria:
Inclusion Criteria:

* patients aged 18 to 75 yrs of age presenting at a clinical site with symptoms diagnostic for an acute upper respiratory tract infection within the last 5 days

Exclusion Criteria:

* patients who had chronic, recurring respiratory signs and symptoms due to conditions such as chronic allergic rhinitis, chronic sinusitis or chronic bronchitis which in the investigator's opinion, confounded interpretation of symptom ratings for the acute upper respiratory infection. Also excluded were patients with a fever greater than 101 degrees F.
Ischaemic Stroke and Sleep Apnea in Northern Part of Finland

Obstructive sleep apnoea is a risk factor for ischaemic stroke. study hypothesis: In prospective study the investigators want to know how many ischaemic stroke patients have sleep apnoea and does thrombolysis play a role in severity of osa in six months follow up.

In prospective study the investigators include all over 18 years old patients who came to emergency room for ischaemic stroke. Exclusion criteria is not able to co-operate or need for intensive care unit.The investigators shall take 100 control patients who have ischaemic stroke and no thrombolysis and 100 study patients who will have thrombolysis. The investigators do sleep registration during hospital staying within 2 days after patients have felt ill.Follow-up registration will be done after 6 months at home.

Eligibility Criteria:
Inclusion Criteria:

* over 18 years old patients that have cerebral palsy and are able to participate to the study.

Exclusion Criteria:

* no co-operation and need for intensive care unit
A Dose-Ranging Study Evaluating the Safety and Efficacy of IDP-107 in Patients With Acne Vulgaris

The purpose of this study is to evaluate the safety and efficacy of IDP-107 versus placebo in treating patients with acne vulgaris.


Eligibility Criteria:
Inclusion Criteria:

* Presence of acne vulgaris on the face and neck/trunk
* Presence of inflammatory and non-inflammatory lesions on the face

Exclusion Criteria:

* Presence of any skin condition on the face that could interfere with clinical evaluations
* Use of any systemic antibiotics or corticosteroids within 4 weeks prior to the Baseline visit
* Use of any systemic retinoids, such as isotretinoin, within 3 months prior to the Baseline visit
* Woman who is pregnant, nursing an infant, or planning a pregnancy during the study period
Halodine Nasal Antiseptic in Patients With COVID-19

Povidone iodine (PVP-I) is a well-known broad spectrum, resistance free antimicrobial agent that has a long history of safe and effective use. Halodine Nasal Antiseptic is formulated for topical application PVP-I to nasal passages, and has demonstrated effectiveness against SARS-COV-2 in vitro - 99.99% inactivation within 15 seconds. This study will evaluate the ability of Halodine Nasal Antiseptic to impact SARS-CoV-2 in vivo.

This is a multicenter, phase 4 prospective, single-cohort study in adult male and female volunteers hospitalized with COVID-19. Baseline nasopharyngeal swabs will be performed on all individuals. Halodine Nasal Antiseptic will then be applied to the anterior nares. Serial nasopharyngeal samples will then be collected at specified time points after the application. All samples will be tested for SARS-CoV-2 by real-time reverse transcription (rRT)-PCR assay.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized with COVID-19
* Positive SARS-CoV-2 (rRT)-PCR within 48 hours of enrollment

Exclusion Criteria:

* Allergies to iodine-containing compounds
A Study of Prexasertib (LY2606368) With Chemotherapy and Radiation in Participants With Head and Neck Cancer

The main purpose of this study is to investigate the safety of prexasertib in combination with other anti-cancer drugs (cisplatin or cetuximab) and radiation therapy in participants with locally advanced head and neck cancer. The study has two parts (A and B). Participants will only enroll in one part.

The primary purpose of Parts A and B of this study is to determine a recommended dose level of prexasertib (an inhibitor of checkpoint kinase 1\[Chk-1\]) in combination with cisplatin and radiation therapy (Part A) or cetuximab and radiation therapy (Part B) in participants with locally advanced head and neck cancer.

Eligibility Criteria:
Inclusion Criteria:

* Must be able to comply with the treatment plan and follow-up schedule
* Must have diagnosis of head and neck squamous cell carcinoma of the oropharynx (tonsil, base of tongue, soft palate, or oropharyngeal walls), hypopharynx, or larynx
* Have adequate organ function
* If participant is of reproductive potential, must agree to use medically approved contraceptive precautions during the study and for six months following the last dose of study drug
* If the participant is a female of childbearing potential, must have had a negative serum or urine pregnancy test within 14 days of the first dose of study drug and must not be breast feeding

Exclusion Criteria:

* Must not have taken an unapproved drug as treatment for any indication within the last 28 days prior to starting study treatment
* Must not have received any of the following prior therapies or treatments: systemic therapy for the study cancer, radiation therapy to the head and neck region, or curative-intent surgery in the head and neck region
* Have evidence of a distant metastatic disease
* Must not have an active symptomatic fungal, bacterial or viral infection, including human immunodeficiency virus (HIV) or Hepatitis A, B, or C
* Must not have a serious heart condition, such as congestive heart failure, unstable angina pectoris, or heart attack within the last three months
* Must not have a family history of long corrected QT interval (QTc) syndrome
* Must not have known allergic reaction against any of the components of the study treatment
Memory and Emotion in Acute and Chronic Phases of Cerebrovascular Accident

The purpose is to determine the relationship between anxiety and cognitive performances in patients with acute and chronic phases of cerebrovascular accident (CVA). Data from neuropsychological assessment concerning cognitive processes (working and episodic memory) sensitive to different dimensions of anxiety will be analyzed.

The secondary purpose is to evaluate how some neurological (hemispherical lateralization of lesions), psychological (depression) and demographic (quality of life) variables can increase the effects of different dimensions of anxiety on cognitive processes, during the acute and/or chronic phase of CVA.

Data will be collected during usual neuropsychological evaluation and cerebral imagery examination (NIHSS, Rankin scale) of patients in acute (0-1 month) and chronic (6 months) phases of CVA.

Eligibility Criteria:
Inclusion Criteria:

* Acute phase of carotid, vertebrobasilar or lacunar cerebrovascular accident with ischemic or hemorrhagic origin
* Right-handed
* Possible cooperation: understanding of French instructions
* Normal or corrected vision
* Normal or corrected hearing
* Mini-mental state examination score higher than pathologic threshold according to age and sociocultural level of patient
* Possible follow up of patient

Exclusion Criteria:

* Hearing problems
* Vision problems
* Right hemiplegia or acute monoparesis of right upper limb
* Hemispatial neglect
* Apraxia
* Psychiatric or neurological history possibly interfering with neuropsychological evaluation
* Important defect of working memory or executive functions
Efficacy and Safety of Radiotherapy Combined With Apatinib Mesylate in the Treatment of Rhabdomyosarcoma in Children

The purpose of this study is to evaluate the efficacy and safety of radiotherapy combined with apatinib mesylate in the treatment of rhabdomyosarcoma in children.

This study is a Interventional study. The target group was 3-18 years old, and the pathological stage was group II-IV recurrence or distant metastasis. A total of 48 patients were enrolled in this study. The treatment was radiotherapy combined with apatinib. The main outcome measures were ORR, DCR , OS , quality of life and drug safety. The main safety indicators were vital signs, laboratory indicators, adverse events (AE), and severe adverse events (SAE). This study is expected to be enrolled for 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be ≥ 3 and ≤ 18 years of age.
* The predicted survival period is more than 3 months.
* According to RECIST version 1.1, there is at least one measurable lesion.
* Postoperative pathological stage was group II-IV.
* Patients have not received radiotherapy before, and can accept chemotherapy and surgical treatment.
* No other anticancer therapy should be used during radiotherapy.
* The main organs are functioning normally, which meets the following criteria:

  1. Blood routine examination standards should be met: (no blood transfusion within 14 days) A.HB\>90g/L; B.ANC\>1.5\*109/L; C.PLT\>80\*109/L
  2. Biochemical tests should meet the following criteria:

A. BIL \< 1.25 times normal upper limit (ULN); B. ALT and AST \< 2.5 ULN; C. Serum Cr \< 1 ULN, endogenous creatinine clearance \> 50 ml/min

* Subjects volunteered to participate in this study, patients or legal guardians signed informed consent through patient consent, good compliance, with follow-up.
* Doctors believe that treatment can benefit patients.
Visual Performance of Prototype Contact Lens Designs

The aim of this study is to assess the visual performance of prototype soft contact lens designs compared to a commercially available contact lens

Prospective, participant-masked, randomised, stratified, crossover, bilateral wear, dispensing clinical trial where participants will wear the prototype (test) and the commercial (control) lens. A minimum of an overnight washout period is required between the fitting /assessment visits.

Eligibility Criteria:
Inclusion Criteria:

* Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent.
* Be at least 7 years old, male or female.
* Willing to comply with the wearing and clinical trial visit schedule as directed by the Investigator.
* Have ocular health findings considered to be "normal" and which would not prevent the participant from safely wearing contact lenses.
* Correctable to at least 6/12 (20/40) or better with both eyes with contact lenses.
* Be suitable and willing to wear contact lenses.

Exclusion Criteria:

* Any pre-existing ocular irritation, injury or condition (including infection or disease) of the cornea, conjunctiva or eyelids that would preclude contact lens fitting and safe wearing of contact lenses.
* Any systemic disease that adversely affects ocular health e.g. diabetes, Graves' disease, and auto immune diseases such as ankylosing spondylitis, multiple sclerosis, Sjögrens syndrome and systemic lupus erythematosus. Conditions such as systemic hypertension and arthritis do not automatically exclude prospective participants.
* Use of or a need for concurrent category S3 and above ocular medication at enrolment and/or during the clinical trial.
* Use of or a need for any systemic medication or topical medications which may alter normal ocular findings / are known to affect a participant's ocular health / physiology or contact lens performance either in an adverse or beneficial manner at enrolment and/or during the clinical trial.
* Eye surgery within 12 weeks immediately prior to enrolment for this trial.

NB: Systemic antihistamines are allowed on an "as needed basis", provided they are not used prophylactically during the trial and at least 24 hours before the clinical trial product is used.
Postpartum Experience by the Second Parent

Many studies have been performed on mothers and their postnatal experiences. Unfortunately, studies about the second parent are very rare. Second parent is yet an essential figure in the parent-child triad and a real support for the mother.

The postpartum period is a time of intense restructuring and upheaval, both physically and psychologically. Studies have shown that almost 13% of fathers suffer from depression.

The main objective is to describe the postpartum experience of the second parent.

Eligibility Criteria:
Inclusion Criteria:

* Males and females
* Second parent of a child born living for at least 3 months and at most 6 months
* Major
* Agreeing to participate in the study

Exclusion Criteria:

* Minors
* Protected by law (guardianship, curatorship, safeguarding of justice)
* Not agreeing to participate in this study
* Parents of stillborn children
* Refusing to participate in the study
BioPoly® RS Partial Resurfacing Patella Registry Study

The data registry will increase the knowledge of outcomes for treatment of focal cartilage defects of the patella treated with the BioPoly RS Patella Implant and will allow monitoring of the clinical safety and performance of the device and surgical implantation kit

The data registry will increase the knowledge of outcomes for treatment of focal cartilage defects of the patella treated with the BioPoly RS Patella Implant This study will also allow monitoring of the clinical safety and performance of the device and surgical implantation kit

Eligibility Criteria:
Inclusion Criteria:

* Age 21 years and older
* Cartilage lesion(s) located in the facets of the patella that have failed prior therapy (conservative or surgical)
* Symptomatic lesions classified as ICRS grade 2, 3, or 4
* Lesion size may not exceed 3.1 cm2 and must be circumscribed by a 15 mm or 20 mm circle of normal or nearly normal (ICRS Grade 0 or 1) cartilage, with an overall depth less than 4 mm from the articulating surface
* Subchondral bone quality sufficient to support the implant
* Understanding and willingness to comply with the post-operative rehabilitation instructions and follow-up visits.

Exclusion Criteria:

* Body mass index (BMI) ≥ 35
* Generalized degenerative or autoimmune arthritis
* Gout
* Uncorrected chronic malalignment of the patella (may be corrected at the same time as the implantation of the BioPoly device).
* Uncorrected ligamentous instability (may be corrected at the same time as the implantation of the BioPoly device).
* Kissing lesion on femur
* More than one implant required to accommodate lesion
* Allergy to ultra-high molecular weight polyethylene (UHMWPE), or hyaluronan/ hyaluronic acid (HA)
* Use with opposing articulating femoral components
* Any concomitant painful or disabling disease of the spine, hips, or lower limbs that would interfere with evaluation of the afflicted knee
* Pregnant, prisoner, vulnerable population, or unable to provide informed consent.
Compression Anastomosis Using the Compression Anastomotic Ring-locking Procedure (CARP)

The intestinal ends must be rejoined after colonic resection. Conventional methods include sutured and stapled anastomoses, which is associated with 3-6% leakage after colonic surgery. The leakage of an anastomosis can cause serious consequences, such as abdominal infections and/or sepsis. Early detection of anastomotic leakage is the best way to avoid serious abdominal infections. The methods that are used today to detect leaks are unfortunately not very accurate. These methods include monitoring symptoms, temperature, and CRP-levels, and performing abdominal examinations and tomography scans. Because of the difficulties in objectively assessing these parameters, the anastomotic leaks are often diagnosed late. When reoperation is required, a permanent stoma may be made at the level of the sigmoid colon. The CARP system has been developed to achieve a safe anastomosis. The CARP is designed to providing an improved contact surface between the two intestinal ends and the ability to precisely investigate the anastomosis during and after surgery using the catheters of the CARP system. Standardized use of the CARP to anastomose the large intestine may provide significant advantages in the field of colorectal surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 - 90 years (male or female)
2. Planned resection due to benign or malign disease in the left colon
3. Cognitive ability to take part in the study and understand the information he/she receives about participating in the study

Exclusion Criteria:

1. Urgent medical condition requiring immediate care
2. Health condition classified as ASA IV
3. Albumin level less than 25 g/l
4. Inflammatory bowel disease (IBD) (ulcerative colitis or Crohn´s disease)
5. Disease that requires more than one anastomosis during the surgical procedure
6. Treatment with cortisone and/or other immunosuppressive medications less than one month before surgery
7. Contraindications to general anaesthesia
8. Cognitive ability that limits the patient's ability to take part in the study and understand the information he/she received about participating in the study, or the patient does not agree to join the study
A Study of Fresolimumab in Patients With Steroid-Resistant Primary Focal Segmental Glomerulosclerosis (FSGS)

The primary objectives of this trial are as follows:

* to compare the achievement of a partial remission (PR) or complete remission (CR) in urinary protein: creatinine ratio (Up/c ratio) in patients treated with fresolimumab versus placebo
* to compare the safety profile of patients treated with fresolimumab versus placebo

The secondary objectives are as follows:

* To compare the reduction in proteinuria in patients treated with fresolimumab versus placebo
* To evaluate fresolimumab dose-dependent reduction in proteinuria
* To compare the change in renal function (estimated glomerular filtration rate \[eGFR\]) in patients treated with fresolimumab versus placebo
* To evaluate the multiple-dose pharmacokinetics of fresolimumab


Eligibility Criteria:
Inclusion Criteria:

* The patient's renal biopsy is consistent with the diagnosis of primary Focal Segmental Glomerulosclerosis (FSGS) including all histological subtypes.
* The patient has an eGFR ≥ 30 mL/min/1.73 m2
* The patient has a urinary total protein:creatinine ratio ≥ 3 mg protein/mg creatinine
* In the opinion of the Investigator, the patient has steroid-resistant FSGS. The patient must have been treated for FSGS with a course of high-dose steroid therapy for a minimum of 4 weeks
* The patient has been treated with an ACEi (angiotensin converting enzyme inhibitor) and/or ARB (angiotensin receptor blocker) at a stable dose for a minimum of 4 weeks prior to Visit 2 (treatment start)

Exclusion Criteria:

* The patient has FSGS which in the Investigator's opinion is secondary to another condition
* The patient has been taking prednisone at a dose \> 10 mg/day (or equivalent dose of an alternative glucocorticoid) within 4 weeks prior to Visit 1 (Screening Visit).
* The patient has received any other systemically administered immunosuppressive drugs (other than glucocorticoids) within 8 weeks prior to Visit 1.
* The patient has received rituximab within 6 months prior to Visit 1.
* The patient has a history of organ transplantation.