cyrilzakka/clinical-trials huggingface dataset:
Duration of Exercise Program in Interstitial Lung Diseases.

We aimed to compare the functional results of the 8th week with the results of the 12th week of the exercise programs applied to the patients with ILD.

Exercise programs (EP) have been shown to be the effective approach for functional outcomes in interstitial lung diseases (ILD). In many studies, the duration of exercise programs varies between 8-12 weeks. However, the optimal duration of exercise program is still unknown.

We aimed to compare the results of the 8th week with the results of the 12th week of the PR programs applied to the patients with ILD.

A total of 14 patients with ILD referred to our PR unit \[11 idiopathic pulmonary fibrosis, 2 sarcoidosis (stage 3 and 4) and 1 nonspecific interstitial pneumonia\] were included in the study. Pulmonary function test, arterial blood gas analysis, 6- minute walk test, mMRC dyspnea scale, quality of life questionnaires and hospital anxiety depression scale were performed before, at the 8th and 12th weeks after the exercise program applied to the patients twice a week.

Eligibility Criteria:
Inclusion Criteria:

* Completed the 12 week exercise program
* Diagnosed with ILD

Exclusion Criteria:

* Not completed 12 week exercise program
Caroverin and Inner Ear Diseases

This trial is a randomized, double blind, placebo controlled study on patients suffering from inner ear diseases with tinnitus as a principal symptom.

The study will investigate the transtympanic treatment with a 1,5 % caroverine solution.

Each patient will undergo treatment for 2 cycles of 48 hours each.


Eligibility Criteria:
Inclusion Criteria:

* Men or women aged at least eighteen
* Written consent to take part in the study after receiving information from the trial physician
* One of the following illnesses:

  * Decompensated tinnitus
  * Sudden hearing loss
  * Morbus Menière
  * Blast injury
  * Presbyacusis with Tinnitus
  * Chron. Otitis media

Exclusion Criteria:

* Patients who are not able to give their consent (e.g. dementia, coma, mental disability,...)
* Women of childbearing age who are not using adequate contraception or who are (or plan to become) pregnant (a pregnancy test must be carried out by a doctor once a month in Austria) or are lactating
* If there are solid reasons to doubt that the patient would be willing and able to cooperate
* Known intolerance of/hypersensitivity to caroverine
* Subjects who have taken part in another clinical trial within the 30 days preceding the start of this study or during this study
* Pulse-synchronous tinnitus
* Tinnitus caused by malposition of the jaw bone (bruxism)
* Eardrum perforation
* Subjects who have previously had a barotraumas, diving accidents or decompression sickness
* Retrocochlear hearing disorder
* Patients who have previously had a fracture of the petrous bone
* Subjects suffering from acute or chronic accompanying conditions which severely impede their general health (NYHA stage IV, cancer, HIV etc.)
* Accompanying conditions that according to the current state of scientific knowledge could affect the parameters used in this study to such an extent as to make it impossible to perform an objective assessment of those parameters, particularly ear conditions, including any conditions affecting the other ear or conditions like HI NYHA stage IV, cancer, HIV, Wallenberg Syndrome, massive Hypotension, Glaucoma.)
* Accompanying medication that according to the current state of scientific knowledge are likely to affect the measurement techniques used in this study or the results obtained (cytostatics, aminoglycoside antibiotics, loop diuretics (furosemide, etacrynic acid), psycho pharmaceuticals, muscle relaxants, benzodiazepines, salicylates, quinine, cortisone and/or caroverine within the three days preceding the start of the study)
* Drug treatment for tinnitus or sudden hearing loss (i.v. and oral) within seven days preceding the start of the study where the total duration of the course is less than four weeks
* Diseases or conditions that may be associated with an altered perception or processing of stimuli, e.g. mental illness
To Evaluate the Efficacy and Safety Aliviador Compared to Gelol in Patients With Contusions, Sprains, Trauma and Muscle Injury.

Multicenter, randomized, double-blind trial, to evaluate the efficacy and safety Aliviador compared to Gelol in the relief of signs and symptoms in patients with contusions, sprains, trauma and muscle injury start with less than 24 hours or patients of myalgia, myofascial pain and tendinitis.


Eligibility Criteria:
Inclusion Criteria:

* Patients of both sexes, of any race, aged over 12 years.
* Ability to read, understand and sign the IC, in the case of minors consent of responsible;
* Clinical diagnosis of bruises, sprains, trauma, muscle damage occurred in less than 24 hours or muscle pain, myofascial pain or tendinitis.
* Patients able to understand and maintain the clinical protocol.

Exclusion Criteria:

* Known hypersensitivity to components of the formulas of both the drug test as the comparator.
* Known hypersensitivity to paracetamol.
* Location of the lesion with skin wound or irritated.
* Liver or kidney disease known.
* Pregnant or lactating women.
* Patients who require surgery or immobilization.
* Patients with fractures or rupture of the ligaments.
* Patients using anticoagulants.
* Patients with severe concomitant systemic diseases, such as cancer, diabetes, or acquired heart disease, hematological diseases, seizure disorders, autoimmune diseases, renal failure, severe infections, hormonal disorders and pulmonary disorders.
* History of alcoholism or illicit drug use;
* Use of NSAIDs, corticosteroids or venoterápicos, topics or any other form of administration.
* Conditions in the opinion of the researcher make the patient unsuitable to participate in the study.
A Study to Assess Adverse Events and Change in Disease Condition of Mesalamine Capsules in Children Aged 5 to 17 Years With Ulcerative Colitis

Ulcerative colitis (UC) is a type of inflammatory bowel disease (IBD) characterized by diffuse, continuous inflammation of the colon. This study will assess how safe and effective mesalamine delayed-release capsules are in treating pediatric participants with UC. Adverse events and change in disease activity will be assessed.

Delzicol (Mesalamine) is an approved drug being developed for the treatment of Ulcerative Colitis (UC). Study doctors put the participants in 1 of 2 groups, called treatment arms. Each group receives a different treatment. Around 80 Pediatric participants aged 5 to 17 years with a diagnosis of UC will be enrolled in approximately 45 sites in the United States.

Participants will receive oral mesalamine capsules twice daily for 26 weeks and followed for 30 days.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.


Eligibility Criteria:
Inclusion Criteria:

- Documented history of Ulcerative Colitis (UC) who have been successfully maintained in remission for at least 30 days prior to the screening visit and are on a stable dose of mesalamine or 5-aminosalicylic acid equivalent.

Exclusion Criteria:

- Abnormal and clinically significant results according to the investigator or designee, on physical examination, medical history, electrocardiogram (ECG), hematology, clinical chemistry, or urinalysis.
Metformin Postpartum for GDM RCT for Reduced Weight Retention

The purpose of this study is to determine whether the study drug metformin is helpful in reducing weight after pregnancy in women with gestational diabetes. This pilot study will provide information on how well women are able to take metformin postpartum, whether metformin increases weight loss, and whether there are any increased risks of side effects to you as a new mother.

At 24-48 hours after delivery, women who are eligible for participation will be approached and consented to the study. Maternal weight will be measured and 20ml of maternal blood will be obtained to assess glucose control and lipid profile. Women will be counseled regarding diet, exercise and glucose control. Data including maternal demographics, clinical characteristics and neonatal outcomes will be collected. At 3 weeks postpartum, a research nurse will contact the subject via telephone call to inquire about adverse or side effects, ability to take the prescribed medication (metformin or placebo), and to answer questions about the study. At 6 weeks postpartum, maternal weight will be measured , blood will be obtained and side effects will be evaluated again. Finally, a satisfaction survey will be completed.

Eligibility Criteria:
Inclusion Criteria:

* Postpartum women with a delivery greater than 34 weeks of pregnancy
* Between the ages of 18 to 49 years
* Women with a diagnosis of gestational diabetes mellitus (either treated with insulin, oral hypoglycemic agent or diet-controlled) after 24 weeks in most recent pregnancy based on a confirmatory 3 hour glucola test (based on either the Carpenter and Coustan's of the Diabetes Task Force criteria)

Exclusion Criteria:

* women with pre-gestational diabetes mellitus (either Type I or Type II DM)
* women unable to tolerate metformin based on patient history
* women who will be discharged hom eon insulin or oral hypoglycemic agent in the immediate postpartum period
* women with a BMI \<25 kg/m²
Unilateral Epidural Block Versus Ultrasound Guided Combined Femoro-sciatic Nerves Block for Patients With Low Ejection Fraction

compare unilateral epidural anesthesia versus femoral/sciatic nerve block by ultrasound guided as anesthetic technique for cases with low ejection fraction undergoing insertion of nail tibia for fixation of fracture shaft tibia.

Group A ;( Unilateral epidural anesthesia group) Forty patients with low ejection fraction (30-40%) will do elective insertion of nail tibia for fixation of fracture shaft tibia using unilateral epidural anesthesia.

Group B;;( Ultrasound guided femoro/ sciatic nerve block group) Forty patients with low ejection fraction (30-40%) will do elective insertion of nail tibia for fixation of fracture shaft tibia by femoral/sciatic nerve block using ultrasound guidance.

For each patient, onset of sensory and motor block, degree of motor block, sign of sensory block in the contralateral lower limb for the epidural group, success in providing adequate anesthesia, hemodynamic changes, time of first analgesic request will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 60 years old.
* Patients scheduled for elective insertion of nail tibia for fixation of fracture shaft tibia.
* Patients with low ejection fraction (30-40%).

Exclusion Criteria:

* Patient refusal
* Uncooperative patient
* Unconscious patients
* Cases with head trauma
* History of relevant drug allergy to local anesthetics
* Local infection at the site of the block
* Patients with coagulopathies and impaired platelet functions
* Patients with hemodynamic instability
* Previous neurological deficit in lower limb and previous femoral artery grafts or injuries.
Efficacy of Intralesional PRP in Treatment of Onychomycosis

This study aims to investigate efficacy of intralesional PRP in treatment of finer nail onychomycosis.

Onychomycosis is a challenging medical condition with limited response to oral antifungal drugs. Recent study demonstrated that platelet rich plasma (PRP) have immuno-enhancing and antimicrobial properties. It had been shown that platelet microbicidal proteins released after platelet activation demonstrate potent activities against many gram-negative, gram-positive, and fungal pathogens in vitro and in vivo studies.

In addition, white blood cell concentration in PRP was reported to be two to fourfold their normal level in whole blood. Neutrophils release myeloperoxidase which has a defensive action against fungi and bacteria, while lymphocytes and monocytes both are immunogenic cells (Badade et al., 2016). Recently, PRP was successfully used in the treatment of multiple recalcitrant plane warts (Abu El-Hamd et al., 2021), Also, PRP proved its efficacy in inhibiting periodontal pathogens such as P. gingivalis and A. actinomycetemcomitans (Badade et al., 2016). In addition, relevance of platelets for antifungal defenses might be suggested by the fact that thrombocytopenia represents a highly significant risk factor for fungal infections in post-transplant liver patients (Chang et al., 2000).

This study compares between intralesional RPR versus oral antifungal versus intralesional PRP + oral antifungal in the treatment of finger nail onychmycosis.

Eligibility Criteria:
Inclusion Criteria:

* Eligible participants will be adult patients (\> 18 years) with onychomycosis confirmed by dermoscopy, direct KOH microscopic examination and positive culture..

Exclusion Criteria:

* Patients with one or more with the following criteria will be excluded.

  1. Pregnant and lactating women.
  2. Patients received topical and/or systemic antifungal therapy during the previous 3 months.
  3. Patients with impaired liver or renal functions.
  4. Patients with anemia (hemoglobin level \<10mg/dl), thrombocytopenia (platelet count \< 100,000 /µL), coagulopathies or patients on anticoagulant therapy as aspirin and patients with iron deficiency.
Lipid Profile Response to Electroacupuncture Stimulation in Non Alcoholic Fatty Liver Patients

sixty female patients suffering from non-alcoholic fatty liver disease were randomly divided into two equal groups group 1 received electroacupuncture stimulation for 6 weeks at special points of stimulation. group 2 was a control group that received nothing without any change in lifestyle and we assed the response of lipid profile post-treatment protocol in both groupes


Eligibility Criteria:
Inclusion Criteria:

non alcoholic fatty liver BMI 30-40

Exclusion Criteria:

* Patients with: (Hepatitis C \& b any form of seizure
Zevalin-BEAM/BEAC With Autologous Stem Cell Support as Consolidation in First Line Treatment of Mantle Cell Lymphoma

The purpose of the study is to determine if outcome for patients with mantle cell lymphoma is improved by adding radioimmunotherapy to high-dose regimen before auto-transplant in patients who are not in CR after induction therapy.

Mantle cell lymphoma is considered to have the worst outcome of all non-Hodgkins lymphomas. Since 1997, the Nordic Lymphoma Group has conducted phase II studies in order to improve the results for this lymphoma subtype. The first study included high-dose therapy with autologous stem cell support in the first line of treatment. The results showed the importance of a high quality response to pre-transplant induction treatment, and that CHOP-based regimen alone did not achieve this. Thus, the second trial was designed to improve remissions by including Rituximab and high-dose Ara-C. Results now show that a high rate of molecular remission in the bone marrow was achieved, and the 3-year FFS was improved in comparison to the first study (80% vs 24%). Furthermore, patient who had a molecular relapse (t(11;14) or IgV-gene) were treated with 4 doses of Rituximab and many converted back to be PCR negative.

The present and thus third phase II study aims to improve the high-dose regimen by adding Zevalin radioimmunotherapy in patients who are not in CR prior to transplant. Data from the last trial show that patients not in CR at this point have a worse outcome (3 year FFS of 63%, vs 85% for CR patients). Monitoring for molecular relapse in the bone marrow will be done, and patients who become PCR positive will be treated with Rituximab in order to evaluate the value of this strategy.

Eligibility Criteria:
Inclusion criteria:

1. Age 18 - 65 years.
2. Histologically confirmed (according to the WHO classification) mantle cell lymphoma stage II-IV at time point of diagnosis. The diagnosis has to be confirmed by phenotypic expression of CD5, CD20 and cyclin-D1 and most cases will have t(11;14) translocation.
3. No previous treatment for lymphoma except radiotherapy or one cycle of any regimen and except patients treated in the previous phase II study who can be transferred to NLG-MCL-III before evaluation at week 15.
4. WHO performance status of 0 - 3.
5. Life expectancy of more than 3 months.
6. Written informed consent.

Exclusion Criteria:

1. Severe cardiac disease: cardiac function grade 3-4 (Appendix 1).
2. Impaired liver, renal or other organ function not caused by lymphoma, which will interfere with the treatment.
3. Pregnancy/lactation
4. Men or woman of reproductive potential not agreeing to use acceptable method of birth control during treatment and for six moths after completion of treatment.
5. Known HIV positivity
6. Any other prior malignancy than non-melanoma skin cancer or stage 0 (in situ) cervical carcinoma.
7. Known seropositivity for HCV, HbsAg or other active infection uncontrolled by treatment.
8. Psychiatric illness or condition which could interfere with their ability to understand the requirements of the study.
A Study in People With Abnormal Fat Levels in the Blood

The purposes of this study are to determine:

* The safety of the study medication and any side effects that might be associated with it;
* Whether the study medication can help patients with low levels of 'good' cholesterol (HDL-C) and high blood fats or triglycerides (TG);
* How much of the study medication should be given to patients;
* How the study medication compares to fenofibrate (Lofibra), a drug used for people with low levels of HDL-C and high levels of TG.


Eligibility Criteria:
Inclusion Criteria:

* Men and women between 18 and 80 years of age
* People with abnormal fat levels in the blood (low HDL, high TG)

Exclusion Criteria:

* People with diabetes
* People whose blood pressure is greater than 160/95 mm Hg, on or off blood pressure medicine
* People who have had frequent chest pain or unstable angina, a heart attack or a heart procedure, including stent placement, within the past 3 months
Assay for the Pancreatic Polypeptide: an Help for Clinical Practice Guidelines in Classification of the Diabetes

The purpose of this study is to evaluate global endocrine function within type 1 and type 3c diabetic patients, helping pancreatic polypeptide measurement.

All diabetes are the result of endrocrine deficiency. The endocrine deficiency may be absolute, as in type 1 diabetes, considered as an elective and exclusive attack of pancreatic Beta cell, or it could be relative, as un type 2 diabetes.

More rarely, diabetes fit into a broader context of pancreatic failure, with diffuse involvement of the exocrine and endocrine function, suggesting an impairment of the whole endocrine secretion of the pancreas, affecting the entire islet of Langerhans, such as in type 3c diabetes, whose prototypes are total pancreatectomy, chronic alcoholic pancreatitis, cystic fibrosis.

The diagnostic of type 3c diabetes is not always obvious, with several clinical presentations, without biological specific disease tag. Moreover, it also appears that the common form of diabetes, type 1 and type 2, may be associated with an exocrine function deficit and with a decrease of the pancreatic volume correlated with exocrine function abnormalities, and a decrease of insulin secretion capacity. The consequences of a spread of the disease beyond the Beta cells remain uncertain, but they could be linked, as in type 3c diabetes, with severe form of hypoglycaemia, due to glucagon deficiency, or nutritional deficiency due to the exocrine deficiency.

The pancreatic polypeptide belongs to the neuropeptide Y family, it is produced by the endocrine pancreatic F cells, located in the hook and the head of the pancreas. Food intake stimulates its secretion. The role of the pancreatic polypeptide in human is uncertain.

Investigators propose to study the pancreatic polypeptide in type 1 and type 3c diabetes before and after a mixed meal in order to study the other endocrine functions of the islet of Langerhans, to evaluate the possibility, or not, of a more diffuse pancreatic involvement in type 1 diabetes, considered as an elective pathology of the pancreatic Beta cell.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years or older
* Patients with type 1 diabetes with anti-GAD and / or IA2 and / or Znt8 positive antibodies, or characteristic clinical history, with and without exocrine deficiency (\*)
* Patients with chronic alcoholic pancreatitis or cystic fibrosis origin (type 3c diabetes), complicated with diabetes defined by HbA1c\> 6.5% or treated with oral anti-diabetic and / or insulin
* Patients who have given informed and written consent to participate in research
* Patients affiliated to a social security scheme (\*): The exocrine deficiency is defined by an assay of fecal elastase:
* without deficit of exocrine function = fecal elastase = /\> 100 μg / g
* with deficit of exocrine function = fecal elastase \<100 μg / g

Exclusion Criteria:

* Pregnancy
* Severe renal impairment (eDFG \<45 mL / min / 1.73 m²)
A Study to Evaluate the Efficacy and Safety of an Experimental Solution for Peritoneal Dialysis

Objective: The purpose of this study is to demonstrate:

-the non-inferiority of an experimental peritoneal dialysis solution compared to a current solution for the management of end stage renal disease (ESRD) in peritoneal dialysis patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have given written informed consent after the nature of the study has been explained.
* Patients who are at least 18 years of age.
* Patients who have been treated with CAPD using specific solutions for at least 60 days before the baseline visit.

Exclusion Criteria:

* Patients who have received antibiotics for the treatment of an episode of peritonitis within 30 days before the screening visit. - Patients who have had acute or chronic exit-site or tunnel infection in the past 14 days, counted from the last day of infection to the screening visit.
* Patients who have other serious diseases, such as active, or if previously treated, residual malignancy or systemic infection.
* Patients who have had a major illness or injury requiring hospitalisation within 30 days before the baseline visit.
* Patients who have severe malnutrition (serum albumin \< 25 g/l by bromocresol green method).
* Patients who are participating in another study that requires Ethics Committee approval. Non-interventional studies are permitted.
* Patients who have received an investigational product within 30 days preceding the screening visit.
* Patients who are pregnant or lactating. (NB: Female patients of childbearing potential must have a negative urine or serum pregnancy test at the time of the screening and will be required to use a medically acceptable means of contraception during their participation in this study).
* Patients who have a significant psychiatric disorder or mental disability that could interfere with his/her ability to provide informed consent and/or comply with protocol procedures.