cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Meloxicam Suspension Versus Diclofenac Suspension or Nimesulide Suspension in Patients With a Diagnosis of Acute, Non-bacterial Pharyngitis, Pharyngotonsillitis or Laryngitis

The objective of this study was to assess the clinical efficacy and safety of meloxicam suspension 0.25 mg/kg/day once a day, versus diclofenac suspension 1 mg/kg/day twice a day or nimesulide suspension 4 mg/kg/day twice a day, after five days of treatment in patients with a diagnosis of acute, non-bacterial pharyngitis, pharyngotonsillitis or laryngitis


Eligibility Criteria:
Inclusion Criteria:

* Patients of both genders between 2 and 8 years old
* Outpatients, with onset of symptoms not more than 72 hours prior to presentation, patients with acute non-bacterial pharyngitis or pharyngotonsillitis diagnosed according to the following criteria:

  * Spontaneous pharyngeal pain, pharyngeal pain upon swallowing, pharyngeal and/or tonsillar hyperemia, absence of purulent plaques, pharyngeal smear negative for ß-hemolytic Streptococcus or Strepto Test® and Treatment with an Non-steroidal anti-inflammatory drugs (NSAID) required or recommended

Exclusion Criteria:

* Known or suspected hypersensitivity to study medications or NSAID's
* Pharyngeal smear positive for ß-hemolytic Streptococcus
* treatment with antimicrobials prior to enrolment in the study
* Chronic infection, infectious mononucleosis, peptic ulcer disease that has been active in the previous 6 months
* Asthma
* nasal polyps
* angioneurotic edema or urticaria after the administration of aspirin or NSAID's
* Concomitant treatment with anticoagulants (including heparin), lithium or methotrexate
* Concomitant administration of other NSAID's (including high dose aspirin) or analgesics, except authorized rescue drugs
* Administration of any NSAID during the three previous days or of analgesics within six hours prior to the administration of the first study drug dose
* Treatment with corticosteroids at the time of enrollment or within the two previous months
* Known liver, renal or hematological disease
* Participation in another clinical trial during the study period or during the previous month
* Previous enrollment in this study
* Inability to comply with the protocol
* Suspected acute bacterial pharyngitis or pharyngotonsillitis (under the following clinical criteria):

  * Clinical presentation characterized by a rapid onset, very high fever (\>38.5°C), severe pharyngeal pain, cervical adenopathy, intense headache, purulent pharyngeal plaques, evidence of peritonsillar abscess or phlegmon
Use of Oxybutynin for Treating Hyperhidrosis: A Placebo-control Study

Video-assisted thoracic sympathectomy (VATS) provides excellent resolution of palmar and axillary hyperhidrosis but is associated with compensatory hyperhidrosis. Low doses of Oxybutynin can be used to treat palmar hyperhidrosis with fewer side effects.

Introduction: Video-assisted thoracic sympathectomy (VATS) provides excellent resolution of palmar and axillary hyperhidrosis but is associated with compensatory hyperhidrosis. Low doses of Oxybutynin can be used to treat palmar hyperhidrosis with fewer side effects.

Purpose: The objective of this study is to evaluate the effectiveness and patient satisfaction with the use of oxybutynin at low doses comparing to placebo for treating palmar hyperhidrosis.

Methods: This is a prospective, randomized and controlled study. From December 2010 to february 2011, 50 consecutive patients with palmar hyperhidrosis were treated with oxybutynin or placebo. Data were collected from 50 patients, and 5 (10,0%) patients were lost to follow-up. During the first week, patients received 2.5 mg of oxybutynin once a day in the evening. From the 8th to the 42nd day, they received 2.5 mg twice a day, and from the 43rd day to the end of the 12th week, they received 5 mg twice a day. All of the patients underwent 2 evaluations: before and after (12 weeks) the oxybutynin treatment, using a clinical questionnaire; and a clinical protocol for quality of life (QOL).

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with hyperhidrosis

Exclusion Criteria:

* Glaucoma and pregnancy
Initiation and Titration of Amaryl

Primary Objective:

* To describe the conditions of initiation and titration of Amaryl M, according to previous treatment:
* initial dose
* titration scheme
* efficacy after 4 months assessed by HbA1C
* tolerability (number and severity of hypoglycaemia)

Secondary Objective:

* Fasting Plasma Glucose
* Weight evolution


Eligibility Criteria:
Inclusion criteria:

* Patients with Type 2 diabetes who have been treated with a stable dose (any dose) of :
* sulfonylurea monotherapy or
* metformin monotherapy or
* free combination of glimepiride and metformin with a stable dose (any dose)
* Body Mass Index (BMI) between 20 and 40 kg/m2
* HbA1c superior or egal to 7.5%
* FPG superior or egal 7 mmol/l

Exclusion criteria:

* Secondary or insulin-dependant diabetes
* Any severe chronic disease (hepatic, renal impairments)
* History of major cardiovascular event in the last 6 months
* Acute conditions with the potential to alter renal function such as: dehydratation, severe infection, shock, IV administration of iodinated contrast agents
* Allergy to sulfonylurea, metformin
* Drug or alcohol abuse
* Pregnancy, lactation

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
e-Cigarette - DNA Adducts

This study will examine the level of toxicity of e-cigarette use compared to smokers and nonsmokers including inflammation markers, toxicant and carcinogen exposure. Additionally, the study will look at the effect of varying voltage levels for e-cigarette users.

In this observational study, e-cigarette users, smokers, and non-users of e-cigarette or tobacco products (up to 134 per group) will be recruited from the Minneapolis-St. Paul area. This research will be conducted at the Tobacco Research Programs at the University of Minnesota. Subjects are screened for eligibility over the phone. If eligible after the phone screen, participants will be invited to attend orientation screening visit in the clinic where consent will be obtained and subjects will complete forms about their tobacco and e-cigarette use and medical history. Subjects who eligible will be asked to return for six visits over the course of six months.

At these appointments, subjects will provide biological specimen samples (buccal cells, urine and blood). Saliva will be collected before and after a smoking or vaping session. Non-users will only have 1 saliva collection.

Subjects will be asked for information pertaining to and e-cigarette and tobacco use and overall health.

Eligibility Criteria:
Inclusion Criteria:

* Good physical health with no unstable medical conditions; Able to provide written informed consent; Stable and good mental health;

Meet criteria for 1 of three groups:

1. Regular smokers confirmed by CO;
2. E-cigarette users (exclusive e-cigarette use for 3 months); Non-Tobacco Users
3. Non-smokers

Exclusion Criteria:

* Unstable medical condition Not willing to attend visits
COVID-19 and Rare Skin Diseases European Observational Study During an Epidemic

This is a European observational cohort study (data research) involving multiple centres to look at the potential impact of COVID infection on patients with rare skin diseases examining factors such as comorbidity, protection factors, and clinical and/or therapeutic factors. The data collected may provide additional information on the situation of patients and, on a wider basis, provide useful data applicable to the general population.

Medical and demographic data will be collected from the medical records of patients. The data required will be specified in Appendix 1 (collection form). Patients will be identified by their initials (first letter of their surname and first name); The study will last for one year to cover the COVID-19 epidemic in France (which includes the areas of mainland France and its overseas departments and territories) and in Europe, via the ERN-Skin European Network.

The frequency of severe forms of COVID-19 will be calculated with a bilateral 95% confidence interval using, as a numerator, the number of patients with a severe form of COVID-19 and, as a denominator, the number of patients with a COVID-19 diagnosis confirmed by PCR, chest scan, serological assay or by suggestive clinical signs during the medical consultation. A severe form of COVID is defined as a case requiring hospitalisation in an intensive care unit, requiring resuscitation, or resulting in death.

Analysis of the impact of COVID-19 infection on rare skin diseases: complications, potential comorbidity factors, impact on the management of chronic conditions (change in treatment) and the experience of patients.

The results of the analysis may be compared with those obtained for other groups of diseases. Gaining a better understanding of high-risk situations, as well as any aggravation or protective factors, should enable us to issue recommendations adapted to this kind of disease but that may also be useful for the general population. This type of study may also provide "reassurance" to patients with rare diseases who have many questions during this period of epidemic and heightened concern.

Eligibility Criteria:
Inclusion Criteria:

* Patient with a rare skin disease,
* Patient of any age (paediatric or adult),
* Patient with suspected COVID-19 infection (remote consultation, face-to-face consultation, general practitioner, hospital physician),
* Patient in contact with a subject infected with the COVID-19 virus,
* Asymptomatic patient for COVID-19 viral infection but with a positive serology,
* Study information given to the patient and/or to their legal representative,
* Patient who has been informed and has agreed to this data collection process.

Exclusion Criteria:

* Patients not suffering from a rare skin disease,
* Patient and/or their legal representative who object to their participation in the study at the presentation of the information leaflet,
* Adult patient unable to understand the implications and constraints of the study,
* Protected adult subject to guardianship or safeguarding measures.
Effect of Exercise in Pediatric Hemophilia

This study investigates the effect of exercise training on pain, physical activity and quality of life in pediatric hemophilia patients.

Hemophilia is a congenital X-linked recessive disease characterized by the lack or absence of clotting factors in the blood. Male individuals with problems in the X chromosome are affected, females are carriers. There are two common types, factor VIII (Hemophilia A) and factor IX (Hemophilia B), and the percentage of the exposed factor in circulation determines the degree of hemophilia disease (\<1% severe, 1-5% moderate,\> 20% mild). The most common clinical symptoms in hemophilia are intra-articular and intramuscular spontaneous bleeding, a history of bleeding that lasts longer than expected after trauma, hemarthrosis and hematomas after crawling or walking in children with moderate or severe hemophilia. Pain, swelling, redness, temperature increase and limitation of movement occur in the bleeding joint. Bleeding into the joint space causes inflammation in the synovial membrane and synovitis occurs. With chronic synovitis, the synovial membrane thickens. Degeneration of the joint cartilage and narrowing of the joint space occurs. Hemarthroses constitute 70-80% of bleeding findings. The most common bleeding joints are knee joints with a rate of 45%. Besides pharmacological treatment for joint and muscle bleeding, the most suitable option is exercise therapy.

The aim of our study is to examine the effect of exercise agitation on pain, physical activity and quality of life in pediatric hemophilia patients. The results of the study indicate that the exercise protocol developed for the lower extremity in pediatric hemophilia patients will have a positive effect on pain, physical activity and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with hemophilia (Hemophilia A) by a hematologist
* Hemophilia is moderate or severe, without spontaneous bleeding complaints
* Having a history of bleeding in the knee joint
* Not doing any regular exercise
* Willing to continue working and will not start other treatment during the study
* Patients whose parents were informed about the study and whose consent form was obtained

Exclusion Criteria:

* Those who have undergone another surgery (joint debridement, fracture, knee replacement) that will affect lower extremity function
* Those with neurological disease or any sensory loss or peripheral nerve injury that may affect functional performance and balance
ICG Distribution Using NIF Imaging After IV Injection of ICG in Benign and Malignant Breast Cancer Tissue.

The purpose of this study is to determine if NIF fluoresent imaging is an effctive approch to detect the margine of the breast tumoral tissue.

Primary objective:

Definition of the histological distribution (intravascular, extra vascular, in specific cells) of ICG (pre-operatively intra-venously injected) at the level of tumoral and healthy tissues of breast cancer patients (and the potential of axillary lymph nodes found fluorescent).

Secondary objectives:

Evaluation of the ability of the fluorescence imaging to determine the tumor volume and, more specifically, the boundaries of tumor tissues which will be analyzed by the pathologist.

Analysis of the correlation between fluorescence and "margins" as defined operatively as tumor (microscopically by the pathologist).

Eligibility Criteria:
Inclusion Criteria:

* Patients with histopathological diagnosis of breast cancer for which a mastectomy with axillary dissection is planned.
* Informed Consent signed.

Exclusion Criteria:

* Diagnosis of breast cancer established by lumpectomy or "macro-biopsy".
* Operation after neo-adjuvant chemotherapy,
* Age less than 18 years.
* For pre-menopausal women, an operation planned for the second phase of their cycle.
* Inability to give informed consent.
* History of allergy or hypersensitivity to the investigational product, iodine.
* Clinical or biological hyperthyroidism.
* Known "toxic" thyroid nodules or known autonomous (hyperfunctional) thyroid.
* A reported pathological coronary artery disease.
* Creatinine \> 1.5 mg / dl.
* During the 2 weeks before surgery, being on medications which are known to interfere with the ICG (ie anticonvulsants, heparin and haloperidol).
* Pregnancy or breast feeding period.
Extending the hCG OPU Interval

Our and others experience suggest that in some cases delaying oocyte pick up (OPU) for more than 39 hours after hCG injection may be of benefit.

We plan to apply this to 20 women in whom less than 20% of oocytes were found suitable for intracytoplasmic sperm injection. The delay will be for up to an interval of 47 hours from hCG to OPU.

In IVF one encounters some women in whom a low percentage of oocytes are found in the metaphase II stage upon their retrieval. Following some incidents, in our experience as well as others', where women injected hCG too early but oocytes were still retrieved with high proportion of maturity, we decided to delay OPU intentionally in women who had low percentage oocyte maturity in previous cycles.

Eligibility Criteria:
Inclusion Criteria: Previous 2 oocyte pick up cycles with 20% metaphase II oocytes in the cohort -

Exclusion Criteria:

No previous IVF history

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Radiologic Score and Failure of Conservative Management of Adhesive Small Bowel Obstruction

The management of acute adhesive small bowel obstruction remains challenging for the digestive surgeon. The Bologna guidelines recommend that conservative management of aSBO. The literature reports that this form of management has a failure rate between 10 and 40%.

A radiological score has been proposed and was associated with an increased risk of failure of conservative management.

This tool is promising to select patients further requiring surgery but it has to be assessed in a multi centric prospective cohort.


Eligibility Criteria:
Inclusion Criteria:

* all the consecutive patients admitted for initial non-surgical management for aSBO
* during the period of inclusion

Exclusion Criteria:

* the cause of SBO was functional or other than adhesive
* patients requiring initial surgical management.
* absence of computed tomography performed at admission
Choroidal Thickness Measurements During Central Serous Chorioretinopathy (CSCR) Treatment

The purpose of this study is to determine changes in choroidal thickness in patients with Central Serous Chorioretinopathy (CSCR) during the first 3 months after initial diagnosis via Enhanced-Depth-Imaging-Spectral-Domain-Optical-Coherence-Tomography (EDI-OCT).

Study hypothesis: Since exudative changes in the choroid seem to constitute the primary pathology of CSCR, changes in choroidal thickness compared to healthy eyes should be present and be visible using EDI-OCT.


Eligibility Criteria:
Inclusion Criteria:

* Patients with initial diagnosis of CSCR and no treatment so far

Exclusion Criteria:

* Therapy (drugs/laser) due to CSCR
An Efficacy and Safety Study of Palovarotene for the Treatment of MO

This is a randomized, double-blind, placebo-controlled study comparing the safety and efficacy of 2 dosage regimens of palovarotene versus placebo in preventing disease progression in pediatric subjects with multiple osteochondromas (MO).

Multiple osteochondromas is a rare condition where children develop multiple benign cartilage-capped bony tumors called osteochondromas on bones throughout the body, resulting in pain, deformity, limb length discrepancy, disability, and eventually arthritis and possible malignancy. The primary objective is to compare the efficacy of two dosage regimens of palovarotene with placebo to prevent the formation of new osteochondromas in pediatric MO subjects with exostosin 1 or exostosin 2 gene mutations. Osteochondroma formation was assessed by whole body magnetic resonance imaging (MRI). Secondary efficacy objectives were to compare the effects of palovarotene with placebo on the volume of osteochondromas as assessed by MRI; the proportion of subjects with no new osteochondromas as assessed by whole-body MRI; the annualized rate of new or worsening deformities; the annualized rate of MO-related surgeries; and palatability. The overall safety and pharmacokinetics of palovarotene and the effects of palovarotene on linear growth, bone growth plates, bone mineral density, quality of life, and pain due to osteochondromas was also studied.

Eligibility Criteria:
Key Inclusion Criteria:

* Written, signed, and dated informed subject/parent consent and age-appropriate assent (performed according to local regulations).
* A clinical diagnosis of MO with disease-causing exostosin 1 or 2 gene mutations.
* Male or female from 2 to 14 years of age.
* Female subjects must be premenarchal at screening.
* A bone age at screening of 14 years or less.
* Symptomatic MO, defined as five or more clinically evident osteochondromas and a new or enlarged osteochondroma that occurred in the preceding 12 months, five or more clinically evident osteochondromas and the presence of a painful osteochondroma, a skeletal deformity, a joint limitation, or prior surgery for a MO-related complication.
* The ability to undergo whole body MRI with or without sedation/general anesthesia.
* Use of two effective methods of birth control during treatment, and for 1 month after treatment discontinuation, unless committed to true abstinence from heterosexual sex. Sexually active females of child-bearing potential must also agree to start effective methods of birth control at screening.

Key Exclusion Criteria:

* Weight under 10 kg.
* Other syndromic conditions such as Langer-Giedion or Potocki-Shaffer.
* Any subject with neurologic signs suggestive of spinal cord impingement.
* Concomitant medications that are strong inhibitors or inducers of cytochrome P450 3A4 activity.
* Amylase or lipase \>2 times the above the upper limit of normal (\>2×ULN) or with a history of chronic pancreatitis.
* Elevated aspartate aminotransferase or alanine aminotransferase above 2.5×ULN.
* Any surgical implant that is contraindicated for MRI.
Preoperative Systemic Therapy vs Upfront Surgery in HER2 Positive Early Breast Cancer

Preoperative systemic treatment can make patients getting more opportunity for breast-conserving surgery, down-staging and new drugs developing. It is particularly common in human epidermal growth factor receptor 2 (HER2)-over expressing subtype for as high as 40%\~60% pCR rate of such a population. Even though, in NSABP B18/27 trials, it had been proved that PST could not improve either disease-free survival (DFS) or overall survival (OS) comparing with postoperatively systemic treatment in total population. We designed a real-world study to investigate the prognosis of anti-HER2 treatment combined with chemotherapy preoperatively versus postoperatively in HER2-positive early breast cancer

Patients with a diagnosis of HER2 positive early invasive breast cancer (cT1-3N0-1M0), from January 2012 to December 2014 were identified and enrolled continuously. The conditions of HER2-positive expression of primary breast cancer were defined as follows: HER2 3+ by immunohistochemical (IHC) method or HER2 2+ by IHC with a further positive result by fluorescence in situ hybridization (FISH). According to the real upfront treatment, all eligible patients were classified as PST group and surgery group. All the patients accepted standard one-year trastuzumab as anti-HER2 treatment combined with chemotherapy. In the PST group, the effect was evaluated according to RECIST1.1 every two cycles, the patients with clinical complete response (cCR) or partial response (PR) would receive the whole course of chemotherapy, those with stable disease (SD) or progressive disease (PD) would receive surgery promptly. After surgery, all patients underwent irradiation and endocrine therapies if necessary. The pCR was defined as the absence of infiltrating residual invasive disease in the breast and axillary nodes. For those non-pCR patients after PST, intensive adjuvant chemotherapy was not routine treatment except patients with progressive disease.The primary endpoint was DFS defined as the time from enrollment to local, regional, or distant recurrences; the occurrence of contralateral breast cancer; or death without evidence of breast cancer. Patients suffered disease progress becoming inoperable before surgery were counted as local treatment failures. The second endpoint was OS defined as the time from study entry to death from any cause. All the endpoints were compared between PST group and upfront surgery group, also further analysis according to pathological response status stratified in PST group.

Eligibility Criteria:
Inclusion Criteria:

1. HER2 positive
2. early invasive breast cancer (cT1-3N0-1M0)
3. using one-year trastuzumab as anti-HER2 treatment

Exclusion Criteria:

1. Exclude metastasis and recurrent breast cancer
2. using trastuzumab less than a year