cyrilzakka/clinical-trials huggingface dataset:
A Prospective, Randomized, Placebo and Active Comparator Controlled Study of CP-690,550 in Subjects With Dry Eye.

A prospective, randomized, placebo and active comparator controlled study of CP-690,550 in subjects with dry eye.


Eligibility Criteria:
Inclusion Criteria:

* Symptoms of dry eye for at least 6 months.
* Signs of moderate to severe dry eye

Exclusion Criteria:

* Women who are nursing or pregnant
* Participation in other studies within 30 days of screening visit
* Ocular disorders that may confound interpretation of study results
Genetics of Aortic Stenosis: From Family Forms to the Common Forms

The association study will compare the allele frequencies of polymorphisms of a single nucleotide (SNP) in the population of individuals with aortic stenosis compared to a control population.

Patients will be included only if they are suffering from a typical form of tight and surgical tricuspid aortic stenosis. Patients will therefore only included if they are suffering from aortic stenosis, the surface is less than 1 cm² and if histological analysis or failing intraoperative findings of the surgeon showed a tricuspid aortic stenosis.


Eligibility Criteria:
Inclusion Criteria:

1. Criteria has reached:

   * That patients are operated or not, they can be considered as having a degenerative aortic stenosis, patients will be diagnosed with aortic stenosis (aortic area \<1 cm) without obvious cause found.
2. criteria not met

   * Strictly normal aortic valve by ultrasound in an over 65-year-old patient.
   * All patients do not fit into the above two categories are considered as having an unknown phenotype and will not be used in binding assays. In particular, the presence of an aortic sclerosis or even moderate aortic regurgitation can be considered as potentially incipient form of aortic stenosis, patients with this type of anomaly will not be scanned during family analyzes.

Exclusion Criteria:

* Patients who did not sign the consent
* Non degenerative aortic stenosis or for which another cause could be found.

Among the most commonly found causes are:

* Bicuspid aortic valve
* Severe renal impairment
* Severe Hypercholesterolemia
Cannabidiol for Inflammatory Bowel Disease

There are many anecdotal reports about improvement of Inflammatory bowel diseases (IBD) with cannabis smoking. The most effective anti inflammatory compound known today is cannabidiol. cannabidiol can be extracted from the cannabis plant, it has no central effect and is fat soluble so it can be given as drops in oil. Doses of up to 500mg did not cause any side effects.

The aim of the proposed study is to examine in a double blind placebo controlled fashion the effect of cannabidiol on disease activity in patients with IBD.

Background: Inflammatory bowel diseases (IBD) are relatively common disease with a rising incidence. Treatment includes various immunocompromising agents including corticosteroids, immunomodulators and biologic agents. Current treatment is not always effective and has many side effect.

Cannabinoids have been known to have anti inflammatory effect, probably via the CB2 receptor. There are many anecdotal reports of cannabinoids in inflammatory disease such as rheumatoid arthritis, and the impression is that cannabinoids do have an ameliorating effect on IBD and that side effects are negligible. However, there are no placebo controled trials in human subjects.

The cannabis plant contains about 600 ingredients, and it is not known which are the active ingredients affecting IBD. The most effective anti inflammatory compound known today is cannabidiol. Cannabidiol can be extracted from the cannabis plant, it has no central effect and is fat soluble so it can be given as drops in oil. Doses of up to 500mg did not cause any side effects.

The aim of the proposed study is to examine in a double blind placebo controlled fashion the effect of cannabidiol on disease activity in patients with IBD.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with a diagnosis IBD at least 3 months before recruitment will be eligible to the study.
2. Patients with active disease who are resistant to either 5 ASA, steroids or immunomodulators, or who can not receive those drugs due to adverse reactions will be offered the possibility of receiving cannabidiol at a dose of 10 mg in sub lingual drops or drops of olive oil as placebo.
3. Disease activity index of either CDAI of more then 200 in Crohn's disease or Mayo score above 3 in UC.
4. Age above 20.

Exclusion Criteria:

1. Patients with a known mental disorder
2. Patients who are deemed to be at a high risk of abuse or addiction to the study drug.
3. Pregnant women
4. Patients who are sensitive to any of the ingredients of the study medication.
5. Patients who are unable to give informed consent.
6. Patients who may need surgery in the near future.
Homeless Care Management App

There is a significant revolving door of incarceration among homeless adults, a population with substantial health disparities. Homeless adults who receive the professional coordination of individualized care (i.e., case management) during the period following their release from jail experience fewer mental health and substance use problems, are more likely to obtain stable housing, and are less likely to be re-incarcerated. The proposed study will use mobile technology to address these barriers and fill gaps in the understanding of the causes of the revolving door of homeless incarceration. This research represents a step toward integrated service connection and healthcare service provision for one of the most underserved, high need, and understudied populations in the United States. Smart phone apps that increase the use of available healthcare services and identify predictors of key outcomes (e.g., homelessness, re-arrest, medication compliance) could be used to reach hard to reach populations with histories of significant and persistent health disparities (e.g., homeless adults).


Eligibility Criteria:
Inclusion Criteria:

* released from Dallas County Jail in the past month
* plan to reside in the Dallas area for the next year
* enrolled in The Bridge Homeless Recovery Program
* willing and able to attend the baseline visit, randomization visit, and the 1, 3, and 6-month follow-up visits
* score ≥ 4 on the REALM-SF indicating \> 6th grade English literacy level
* score \>24 on the Mini-Mental State Exam indicating no substantial cognitive impairment.

Exclusion Criteria

* Cannot read English
* Under the age of 18
Preoperative Intraarterial Chemoembolization Combined With Radiotherpy in Locally Advanced Rectal Cancer

Compared to postoperative chemotherapy combined with radiotherapy, preoperative chemotherapy combined with radiotherapy shows higher sphincter preservation rate and lower local recurrence rate in locally advanced rectal cancer. The purpose of this study is to evaluate the response and prognosis of intraarterial chemoembolization and intravenous infusion chemotherapy in patients with rectal T3-T4 and/or N+ rectal cancer before operation.


Eligibility Criteria:
Inclusion Criteria:

* Histologic or cytologic diagnosis of rectal cancer, Stage IV.
* Males or females between 18 Years to 75 Years.
* No prior cisplatin-based chemotherapy or radiotherapy.
* Performance status of 0～2 on the ECOG criteria.
* Adequate hematologic (Leukocyte count \>= 4,000/uL, neutrophil count \>= 1,500/uL, hemoglobin \>= 10 g/dL, platelets \>= 100,000/uL), hepatic (AST \& ALT =\< upper normal limit(UNL)x1.5, bilirubin level =\< UNLx1.5), and renal (creatinine =\< UNL x1.5 or creatinine clearance rate ≥60 ml/min) function.
* Patient can take oral medicine
* Patient compliance that allow adequate follow-up. Informed consent from patient or patient's relative.

Exclusion Criteria:

* Patient with allergic to S-1 or ingredient of Oxaliplatin
* Patient with Peripheral neuropathy
* Diagnosed fibrosis of lung;pulmonary fibrosis or interstitial pneumonia within 28 days.
* Medically uncontrolled serious heart, renal failure, liver failure, hemorrhagic peptic ulcer, paralysis of intestine , ileus, poor controlled diabetes.
* Enrollment in other study.
* Pregnant or breast-feeding.
* Seriously psyche or intelligence problem.
* Inability to comply with protocol or study procedures.
Double Trunk Mask and Standard Nasal Cannula During Acute Hypoxia

The objective of the study is to determine whether adjunctive mask of our design (Double Trunk Mask - DTM) has an effect on increasing arterial pressure in Oxygen (PaO2) diagnosed with severe hypoxia.

This is a single-center, randomized, blind investigator, 2-way crossover study design. Enrolled participants had hypoxia being treated at Intensive Care Unit associated with a hospital in Hornu (Epicura).

The study consisted of two intervention periods separated by a washout period of 30 minutes.

The objective of the study is to determine whether adjunctive mask of our design (Double Trunk Mask - DTM) has an effect on increasing arterial pressure in Oxygen (PaO2) diagnosed with hypoxia.

The protocol and informed consent documents were reviewed and approved by a recognized ethics review board at the study facility. The study was performed in accordance with the Declaration of Helsinki.

Eligibility Criteria:
Inclusion Criteria:

* Regardless of gender, at least 18 years of age and diagnosed with Hypoxia (PaO2/FiO2 \< 380 mm Hg), dyspnea, respiratory rate (RR) ≥ 25 CPM, PaCO2 ≤ 45 mmHg, patient with an arterial catheter and without hemodynamic instability, Glasgow Coma Scale ≥ 12/15, written consent. Participants were also required to have a sufficient level of education to understand study procedures and be able to communicate with site personnel.

Exclusion Criteria:

* Patients were excluded if they Hypercapnia (\> 45 mm Hg with respiratory acidosis), COPD, pulmonary fibrosis, hypoventilation obesity syndrome, arterial pressure \< 60 mm Hg or treatment by epinephrine \> to 0,1 gamma/kg/minute, deterioration of awareness (Glasgow scale \< or = 12), acute confusional state.

Participants were randomized in a 1:1 ratio to receive either classical oxygenation with nasal cannula (NC) for 20 minutes or NC with an adjunctive of a Double Trunk Mask.
A Pre-Op Window Study Evaluating Anti-Proliferative Effects of Atorvastatin on the Endometrium

This is a preoperative window, phase 0 study of short-term atorvastatin treatment in obese women who are to undergo surgical staging for endometrial cancer.

This is a preoperative window, phase 0 study of short-term atorvastatin treatment in obese women who are to undergo surgical staging for endometrial cancer. After recruitment is completed, 24 paired endometrial biopsies and hysterectomy specimens from endometrial cancer patients treated at University of North Carolina at Chapel Hill will be retrospectively obtained from the Department of Pathology to serve as controls. These cases will be matched for stage and grade to the endometrial cancers of those women enrolled on this phase 0 clinical trial and will undergo the same immunohistochemical analysis. Two previous phase 0 window studies of metformin in endometrial cancer have found no difference in Ki-67 expression between preoperative endometrial biopsy and hysterectomy specimen in control patients, although a difference was seen in metformin treated patients. However, the investigators plan to include a control group to ensure that changes found between pre- and post-atorvastatin treated patients are due to the effects of this drug versus differences in the type of specimen examined (i.e. endometrial biopsy specimen obtained in clinic versus hysterectomy specimen obtained at the time of surgery). In addition, enrolled patients will undergo repeat endometrial biopsy post- atorvastatin treatment at the time of their surgical staging. Thus, study investigators plan to compare pre-treatment endometrial biopsies to both post-treatment endometrial biopsies and hysterectomy specimens as well as have a historical control group.

Eligibility Criteria:
Inclusion Criteria:

* Be between the ages of 18-75 years old
* Have a confirmed diagnosis of type I endometrial cancer (endometrioid) based on pre-operative endometrial biopsy or dilation and curettage (D\&C)
* Have a BMI \>30
* Have no contraindication to short-term atorvastatin therapy
* Have a serum creatinine ≤ 1.0 mg/dL
* Have normal serum transaminase values (AST and ALT)
* Need to be able to undergo atorvastatin treatment for a minimum of 2 weeks but no more than a maximum of 4 weeks prior to surgical staging

Exclusion Criteria:

* Are currently taking a statin or have taken a statin in the past 6 months or have a history of an allergic reaction or intolerance at any time to a statin
* Have a history of liver or renal dysfunction
* Have a history of alcoholism
* Are pregnant
* Are currently taking any hormonal therapy or have been on hormonal therapy in the past 4 weeks
* Are taking a drug that may significantly interact or influence the metabolism of atorvastatin
* Concomitant cyclosporine, gemfibrozil, telaprevir, or tipranavir/ritonavir use
* History of stroke or transient ischemic attack in the preceding 6 months
Platelet-rich Plasma(PRP) Injection in ED

RPR contains rich-in growth factors and has the properties of helping tissue regeneration and nerve repair. In theory, it is possibility of curing ED.

There are many reasons of erectile dysfunction(ED). If left untreated, there is a major impact on relationships, self-esteem, and overall health. RPR contains rich-in growth factors and has the properties of helping tissue regeneration and nerve repair. Its mechanism is to promote the regeneration of blood vessels in the cavernous body of the penis, increase blood circulation, and then help erection, increase penile stiffness and improve the phenomenon of premature ejaculation. The main purpose of this study is to study the safety and effectiveness of PRP injection for the treatment of ED.

Eligibility Criteria:
Inclusion Criteria:

* Male
* Between 20 and 70 years old
* Sexual dysfunction exists for at least 6 months
* IIEF-5 score 8-2
* Sign an informed consent form

Exclusion Criteria:

* Ever radical prostatectomy or extensive pelvic surgery
* Radiation therapy to the pelvic area within 12 months before recruiting
* Cancer
* Nervous system diseases that affect erectile function
* Have any blood disease
* History of coronary artery disease
Assessment of Factors Influencing Parents' Attendance Time During Feeding Time of Premature Infants Born Before 35 Weeks of Amenorrhea in Besançon University Hospital

The precise description of parental presence and the associated factors will make it possible to construct an intervention in order to correct potentially low parental participation. The demonstration of the effectiveness of such an intervention will be the subject of a larger study (PHRIP type). Ultimately, the investigators want to personalize the daily support for parents to offer optimal support for parenting.

Considering the importance of the bond of attachment, and in particular the emotional tuning between the adult and the premature baby and the particularly important interactions during feeding, it seemed essential to us to make an evaluation of the parental presence during the meals. , which sheds light on the factors influencing this presence.

The presence time seems to vary depending on: the child's background, the profile of the parents, the profile of the child and environmental factors.

Knowing the factors influencing this presence is essential in order to understand the obstacles to the arrival of parents, to think as a team and to offer personalized support in order to allow them to be more present with their baby.

Eligibility Criteria:
Inclusion Criteria:

* Premature newborn under 35 weeks of amenorrhea (AS), hospitalized at Besançon University Hospital,
* Newborn baby whose parents:

expressed their non-opposition to participate in the study, are affiliated to a social security scheme, are of age, express themselves easily in French.

Exclusion Criteria:

* Newborn baby whose parents object to participating in the study,
* Newborns presenting severe malformative anomalies, or malformations of the oral sphere,
* Newborn baby whose transfer is scheduled before the end of hospitalization (excluding birthing pool at the CHU de Besançon).
Double-blind Study of Safety and Immunogenicity of Two Candidate Malaria Vaccines in Gabonese Children

GSK Biologicals is developing a number of candidate malaria vaccines for the routine immunization of infants and children living in malaria-endemic areas. The candidate vaccines are designed to offer protection against malaria disease due to the parasite Plasmodium falciparum. Candidate vaccines containing the RTS,S antigen would also provide protection against infection with hepatitis B virus (HBV). This study will evaluate two candidate vaccines. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.


Eligibility Criteria:
Inclusion criteria:

* A male or female child between 18 months and 4 years of age (up to but not including 5th birthday) at the time of first vaccination.
* Written or oral, signed or thumb-printed and witnessed informed consent obtained from the parent(s)/guardian(s) of the child.
* Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g. return for follow-up visits)

Exclusion criteria:

* Acute disease at the time of enrolment.
* Serious acute or chronic illness determined by clinical or physical examination and laboratory screening tests.
* Laboratory screening tests for haemoglobin, total white cell count, platelets, ALT and creatinine out of range.
* Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine(s) with the exception of tetanus toxoid.
* Use of any investigational or non-registered drug or vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* Administration of immunoglobulins, blood transfusions or other blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
* Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
* Previous participation in any other malaria vaccine trial.
* Simultaneous participation in any other clinical trial.
* Same sex twin.
* History of allergic reactions (significant IgE-mediated events) or anaphylaxis to previous immunizations.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
* Any other findings that the investigator feels would increase the risk of having an adverse outcome from participation in the trial.
Effects of Instrument Assisted Soft Tissue Mobilization in Addition to Conventional Physiotherapy in Knee Arthrofibrosis

Arthrofibrosis is the abnormal proliferation of fibrous tissue within a joint and around the joint that leads to loss of motion, pain, muscle weakness, swelling, functional limitation. Study conducted to determine additional effects of IASTM along with conventional physiotherapy as compared to conventional physiotherapy alone on Range of motion, functional limitation and pain in knee arthrofibrosis.

Arthrofibrosis is common condition after surgeries, most of the arthrofibrosis literature addresses arthrofibrosis after arthroplasty or ligamentous reconstruction, and it is replete with manipulation under anesthesia or with arthroscopic interventions or both. Study will be conducted over period of 1 year at fauji foundation hospital.Ethical approval from ERC foundation university medical college. Participants recruited and written inform consent, following which they will be required to complete a self-reported demographic form. The data will be entered and analyzed on SPSS 22. IASTM is simple and effective intervention to improve Rom and functional limitation in patients with knee arthrofibrosis

Eligibility Criteria:
Inclusion Criteria:

* post Total knee replacement patients
* Extension lag \>10
* Flexion deficit \>25
* Age 18_60
* both male and female
* Numeric pain rating scale between 3-5

Exclusion Criteria:

* skin allergy
* Diabetic patient
* Any vascular disease
* Prolonged use of Corticosteroids
* Any infective or active inflammatory condition
* Fracture or dislocation
* Lower extremity functional scale score above 71.
Iron Supplementation in Schistosomiasis and Soil Transmitted Helminths Control Programmes in Zambia

The objectives of this study is:

* to establish the coverage rate of weekly iron supplementation in children in intervention schools over a period of nine months
* document any side effects of weeekly iron supplementation among children in intervention schools over a period of nine months asses the feasibility of incorporating the weekly iron supplementation programme into the normal school activity in intervention schools determine the extent of acceptability and support for the iron supplementation programme by staff at the health centre nearest to the intervention schools
* compare the praziquantel efficacy and schistosomiasis reinfection in children in intervention schools with that of children in control schools following the introduction of weekely iron supplementation over a period of nine months
* determine the impact of weekly iron supplementation on haemoglobin levels of children in intervention schools and compare with children in control schools over a period of nine months

Iron deficiency anaemia is a common denominator for both schistosomiasis and soil transmitted helminths. Iron deficiency appears to affect the immune response against schistosomes and intestinal helminths. It therefore follows that correcting the iron deficiency anaemia will improve the efficacy of anthelminthics such as praziquantel (against schistosomiasis) and albendazol (against soil transmitted helminths) and ability of the host immune system to resist reinfection with schistosomes and soil transmitted helminths.

The aim of this study is to identify factors necessary for a successful weekly iron supplementation programme in schistosomiasis and soil transmitted helminths control programmes. In addition impact of weekly iron supplementation programme n haemoglobin levels, efficacy of praziquantel, and schistosomiasis re-infection will be studied.

Eligibility Criteria:
Inclusion Criteria:all schoolchildren, in grade 2 and 3, at four selected schools -

Exclusion Criteria:

-