cyrilzakka/clinical-trials huggingface dataset:
At Home Ammonia Monitoring of Inborn Errors of Ammonia Metabolism

The goal of this observational study is to learn if people with certain ammonia metabolism disorders will measure their ammonia levels at home.

The main question it aims to answer is:

• Will participants measure their ammonia every day?

Participants will be asked to:

* Attend three in-person study visits at the clinic.
* Measure temperature, heart rate, and blood oxygen every day.
* Complete a short survey every day.
* Measure ammonia every day.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed ammonia disorder such as

  * Ornithine transcarbamylase deficiency
  * Systemic primary carnitine deficiency
  * Type I citrullinemia
  * Argininosuccinic aciduria
  * Isolated methylmalonic acidemia
  * Type II citrullinemia
  * Propionic acidemia
  * Isovaleric acidemia
  * Multiple acyl-CoA dehydrogenase deficiency
  * Pyruvate carboxylase deficiency
  * Argininemia (arginase deficiency)
  * Carbamoyl phosphate synthase I deficiency
  * Dihydrolipoamide dehydrogenase deficiency
  * Lysinuric protein intolerance
  * Hyperornithinemia-hyperammonemia-homocitrullinuria
  * Carnitine-acylcarnitine translocase deficiency
  * Carbonic anhydrase VA deficiency
  * N-acetyl glutamate synthetase deficiency
* English Literacy

Exclusion Criteria:

* Incarcerated
* Presence of a non-inborn error of metabolism medical condition associated with abnormal ammonia metabolism (e.g., end stage liver disease).
* Unable to read in English
A Comparison of Three Different Formulations of Prednisolone Acetate 1%

Generic prednisolone acetate 1% is less effective than Pred Forte 1% or Econopred Plus 1%.

Overall Study Design:

Structure:

This is a randomized, double-masked prospective study. The study medications will be masked and randomized by the outpatient pharmacy at Indiana University Hospital.

Duration:

Treatment duration: The duration of each subject's participation will be for up to 2 months after surgery. One hundred and two subjects will be enrolled over a twelve-month time span.

Controls:

Examiner, staff, and subjects are masked. Parallel group comparison.

Dosage/Dose Regimen/Instructions:

Subjects scheduled for glaucoma and/or cataract surgery will be recruited. Subjects may not be currently on any steroid or ophthalmic non-steroidal anti-inflammatory (NSAID) therapy for a minimum of 6 weeks prior to surgery. Subjects will be randomized to receive a dose of Pred Forte 1% (Allergan), Econopred Plus 1% (Alcon) or prednisolone acetate 1% (Falcon) four times a day starting immediately after finishing the surgery for two weeks, then twice a day for two more weeks. After 1 month of therapy subjects will stop or continue steroid treatment based on clinical findings. No other subconjunctival steroid or ointment will be used intra-operatively or post-operatively. The eye drop will be instilled per labeling instructions.

Eligibility Criteria:
Inclusion Criteria:

* Be willing and able to provide written informed consent.
* Be able and willing to follow instructions on the use of the study medication and likely to complete the entire course of the study.
* Be male or female of any race at least 18 years of age.
* Have visually significant cataract or medically uncontrolled glaucoma for which they have elected to undergo surgery.

Exclusion Criteria:

* Contraindication to use of corticosteroids.
* Ocular disease other than glaucoma or ocular hypertension that would interfere with study parameters (such as: uveitis, ocular infection, or severe dry eye). Subjects with mild chronic blepharitis, age-related macular degeneration and background diabetic retinopathy may be enrolled at the discretion of the investigator.
* Laser or any other intraocular surgery within the past three months.
* Require use of ocular NSAID or systemic steroids.
* Have known allergy or sensitivity to the study medications or their components
* Have corneal abnormalities that would interfere with the ability to obtain an adequate laser flare measurement.
* Be concurrently enrolled in an investigational drug or device study or participation within the last 30 days in any investigational drug or device study.
* Be pregnant, nursing, planning a pregnancy, or be of childbearing potential and not using a reliable form of contraception (a woman is considered of childbearing potential unless she is postmenopausal, has had a uterus and/or both ovaries removed, or has had a bilateral tubal ligation).
* Have a situation or condition that in the investigator's opinion may put the subject at significant risk, may confound the study results, or may interfere significantly with participation in the study
Efficacy and Safety of a Covered Self-expandable Dual-layered Metallic Mesh Stent (UVENTA) in Ureteral Obstruction

The purpose of this study is to evaluate Efficacy and Safety of a covered self-expandable dual-layered metallic mesh stent (UVENTA) in ureteral obstruction.

Prospective, Multi-center, open label, single arm Study

1. Treatment

   - Covered self-expandable dual-layered metallic mesh Stents(cSEMS) are implanted in patents with malignant ureteral obstruction
2. Follow up

   * Assessments including X-ray(KUB), are done 3, 6, 12, 18 and 24 months after the procedure.
   * Diuretic RI scan (DTPA, MAG-3) 3, 6, 12 months after the procedure
   * Imaging such as IVP(Intravenous Pyelogram), ultrasonogram, CT(Computed Tomogram) are performed at 6 and 12 months.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who voluntarily agree to participation and submitted a written informed consent for this study, and 20\~80 years
2. One out of following cases below apply to Patients who have malignant ureteral obstruction or have benign ureteral obstruction without improvement after previous treatment

   * Patients who doesn't want to have regular replacement of plastic stent
   * Patients who has no improvement of obstruction after plastic stent implant
   * Patients who want other Urinary diversion because of stimulatory sign or pain due to plastic stent
3. Patients with no previous ureteral metal stenting procedure experience.
4. Patients with more than 6 months of life expectancy
5. Patients understanding the objective of the study and who are willing to sign a consent

Exclusion Criteria:

1. Patients with Urothelial Carcinoma
2. Patients with bladder invasion of malignant tumor
3. Patients with bladder dysfunction or obstruction of lower urinary tract
4. one or more times Recurrent Urinary stone in the last 3 years
5. 2 or more times upper urinary tract infection without upper urinary tract obstruction
6. Karnofsky scores \< 60
7. Patients with Bacteriuria
8. Inadequate Patient to participate in the study as judged by the investigator
RCT of Carvedilol Versus Variceal Band Ligation in the Primary Prophylaxis of Oesophageal Variceal Haemorrhage

Aim To compare Carvedilol with variceal band ligation in the prevention of first variceal bleed.

End points of trial Primary: Variceal hemorrhage Secondary: Death

Study design

Randomised controlled clinical trial. Results analysed for the above end points on an intention-to-treat basis.

Patients from the Gastroenterology section of the Aga Khan University, Karachi, with liver cirrhosis and on endoscopy having grade II, or larger oesophageal varices and who have not bled previously from varices.

Method All suitable patients will be recruited after informed consent is given. Randomisation of treatment is by sealed envelopes prepared in batches of 20.

Carvedilol This will be administered as a once daily dose of 12.5mg.

Variceal band ligation Endoscopy will be performed ever two weeks until eradication of oesophageal varices. Eradication is achieved when no varices or only grade I varices (varices which are small and flatten on air insufflations in the oesophagus) are present. Subsequent endoscopy sessions will be progressively less frequent, at intervals of 3 months, 6 months and 12 months thereafter. Should varices recur, the protocol for eradication as described above will be re-instituted.

Follow-up This will take place in a dedicated clinic. First visit is six weeks after initiation of treatment and three monthly thereafter. Clinical and laboratory parameters will be obtained at each visit. All patients with alcoholic liver disease will be asked to provide an up-to-date status on drinking. Treatment will cease upon reaching any of these end-points: variceal haemorrhage, death or liver transplantation. Duration of follow-up is defined as time from randomisation to the above end points or to the last follow-up date available.

Eligibility Criteria:
Inclusion Criteria:

* Patients with liver cirrhosis and on endoscopy having grade II, or larger oesophageal varices and who have not bled previously from varices.

Exclusion Criteria:

* Age \<18 or \> 75 years.
* Pregnant or lactating patients: patients of childbearing age who are not on contraception.
* Allergy to Carvedilol.
* Already on beta blockers or nitrates.
* Presence of malignancy that will significantly affect survival.
* Presence of severe systemic illness e.g. cardiorespiratory, active sepsis.
* Psychiatric disease or learning difficulty that will prevent the granting of informed consent.
* Presence of obstructive airways disease.
Bizarreness and Anomalous Self Experiences in Schizophrenia

Several authors suggest that the specific experience felt in clinical encounter, called Praecox Feeling, is directly linked to the psychopathology of Schizophrenia.

However, determining factors of this phenomena, whether cognitive or subjective, remains poorly studied.

Furthermore, Self-Disorders are alterations of the first-person experience regarded as specific of the disease. The investigators plan to study in an exploratory way the phenomenological and subjective links between Praecox Feeling and Self Disorders determinants, while hypothesizing that the clinician's Praecox Feeling can be positively correlated to SDs, as our main objective.

Several authors suggest that the specific experience felt in clinical encounter, called Praecox Feeling, is directly linked to the psychopathology of Schizophrenia. However, subjective, cognitive or neurophysiologic aspects of this phenomena remains poorly studied.

Furthermore, Self-Disorders (SD) are alterations of the first-person experience and of sense of agency, regarded as specific of Schizophrenia. Unlike Praecox Feeling, clinical, cognitive and neuropsychological determinants of SD are increasingly studied.

The investigators plan to study in an exploratory way the links between Praecox Feeling and SDs determinants, while hypothesizing that the clinician's Praecox Feeling can be positively correlated to SDs, as our main objective.

As a secondary outcome, the investigators will control this correlation by a comparison between SDs evaluation and clinician subjectivity.

The present study also plan to evaluate the associations between Praecox Feeling and clinical features, low and high cognitive level with attentional and social cognition evaluations.

The first step of the research project is to implement this exploratory design in a transversal multicentric setting between centers with a limited number of participants and without follow-up.

Eligibility Criteria:
Inclusion Criteria:

* People with a diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria.
* Psychiatric medical situation judged clinically stable : no change of main antipsychotic in treatment in last 15 days.
* People who has given his non-opposition
* Patients affiliated to a social security system

Exclusion Criteria:

* Previous meeting of the participant with one of the investigators involved in the clinical assessment and scoring of the study scales.
* Person with a moderate to severe intellectual disability (clinical criteria).
* Person with a neurological pathology with cognitive impact
* Patients with legal protection
A Pumpkin Seed, Isoflavonoid and Cranberry Mix in LUTS/BPH

The aim is to assess the efficacy of a mix of Pumpkin Seed Extract, Soy Germ Isoflavonoids and Cranberry (Novex®) in the management of mild to moderate LUTS in BPH patients. The patients will be evaluated based on the severity of LUTS, urological quality of life, and erectile function.

This is a single-arm prospective open-label trial investigating a combination of pumpkin seed, isoflavonoid and cranberry mix in improving LUTS, urological quality of life, and erectile function in BPH patients. The compound will be administered orally two tablets daily for 3 months. Recruited patients will be seen at 3 visits: initial visit (visit 1), 1-month visit (visit 2) and 3-month visit (visit 3) and their data will be collected in a dedicated case report form.

Eligibility Criteria:
Inclusion Criteria:

* mild to moderate LUTS due to BPH for at least 6 months at the initial visit
* no previous therapy or are still symptomatic despite the current use of alpha-blockers

Exclusion Criteria:

* International Prostate Symptom Score (IPSS) \> 19
* Prostate cancer
* Urethral stenosis
The Effects of Different Degrees of Head-of-bed Elevation

The patient's position is important for ensuring patient comfort and preventing complications after thyroidectomy. This study was carried out to determine the effects of different degrees of head-of-bed elevation on the respiratory pattern and drainage following thyroidectomy and to provide suggestions for evidence-based clinical practice.

Thyroidectomy is a safe surgical procedure commonly used for the treatment of benign or malignant tumors, multinodular goiter and Graves disease. However, because of the rich vascular structure of the thyroid gland, serious complications including hemorrhage, hematoma and hematoma-related dyspnea can develop after thyroidectomy. The American Thyroid Association also suggested to keep the patient in a head-up at 45°-Fowler's position in the post anesthesia care unit following thyroidectomy to prevent hematoma formation on the incision site by facilitating venous return from the head and neck. The mentioned guideline does not offer any recommendations regarding the position that should be given to the patients at surgical clinic after thyroidectomy. Therefore, this study aimed to identify the effects of different degrees of head-of-bed elevation on respiratory pattern including respiratory rate, peripheral oxygen saturation and dyspnea, and drainage including amount of drainage and hematoma formation.

Eligibility Criteria:
Inclusion Criteria: The eligible participants were those

* who were not using anticoagulants,
* whose coagulation tests were normal,
* who had hemovac drains inserted during thyroidectomy,
* who had no contraindication to positioning (e.g., heart failure, chronic obstructive pulmonary disease, dyspnea before surgery and respiratory complications in the post-anesthesia care unit),
* who could tolerate positioning, and who volunteered to participate and signed the informed consent form

Exclusion Criteria:The participants excluded from the study;

* who were using anticoagulants,
* whose coagulation tests were abnormal,
* who had hemovac drains inserted during thyroidectomy,
* hemovac drains removed in the post-anesthesia care unit following thyroidectomy,
* who did not tolerate positioning and who refused to participate
Effect of Compound Amino Acid Tablets on Nutritional Status of Patients With Lung Cancer

To investigate whether compound amino acid supplementation can further promote protein synthesis and improve nutritional status for lung cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* NRS2002 \>=3 scores
* lung cancer patients
* low albumin or hemoglobin
* informed consent

Exclusion Criteria:

* Acute and critical patients;
* Severe liver and kidney dysfunction;
* Patients with gastrointestinal bleeding or intestinal obstruction;
* Pregnant women, lactating women, people with mental illness, and people without independent behavior ability.
The Role of Immune Semaphorins in NAFLD

To goal is to identify semaphorins that are associated with NAFLD and to investigate their relationship with variable degrees of steatosis and fibrosis.

Nonalcoholic fatty liver disease (NAFLD) is the most common chronic liver disease associated with systemic changes in immune response. Semaphorins were recently recognized as one of the key regulators of immune responses; while some suppress immune cells activation, proliferation, and production of inflammatory cytokines, others stimulate immune responses. We have previously shown that semaphorins are associated with pathogenesis of viral hepatitis and progression of fibrosis. However, their role in NAFLD is unknown. The hypothesis of this project is that semaphorins are regulators of inflammation in patients with NAFLD. This study is designed as a prospective, non-interventional study. The main aims are: (1) to analyze serum concentration of semaphorins in patients with NAFLD; (2) to analyze tissue expression of semaphorins in patients with NAFLD; (3) to analyze semaphorin gene polymorphisms associated with NAFLD. Semaphorins could be a novel diagnostic and prognostic biomarker as well as targets for immune modulation.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with NAFLD according to current guidelines (AASLD, EASL)

Exclusion Criteria:

* Immunosuppression
* Malignancies
* Autoimmune diseases
* Pregnancy
* HIV
* Chronic viral hepatitis
* Presence of other chronic liver disease (hemochromatosis, Wilson's disease, toxic hepatitis, deficiency of alpha-1-antitrypsin, liver autoimmune disease)
* Consumption of alcohol \> 20 g/day
Long Acting Insulin Versus Multiple Dose Regimen for Control of Gestational Diabetes Mellitus

multiple dose regimen as a standard treatment for gestational diabetes will be compared to long acting insulin


Eligibility Criteria:
Inclusion Criteria:

* pregnant women with gestational diabetes mellitus
* between 24-28 weeks gestation

Exclusion Criteria:

* other endocrinological abnormalities
Randomized Trial Comparing Misoprostol and Foley Bulb for Labor Induction in the Preterm Gestation

The purpose of this study is to compare the time to delivery of two different cervical ripening methods on the preterm gestation.

Labor induction for the preterm gestation is indicated for various maternal and fetal indications. The preterm cervix, however, is frequently not favorable for induction. Multiple methods have been evaluated in the term gestation. As these comparison studies have not included the preterm gestation, this study seeks to evaluate these two methods in terms of safety, efficacy and time to delivery.

Eligibility Criteria:
Inclusion Criteria:

* singleton gestation, gestational age 23-35 weeks, indication for induction

Exclusion Criteria:

* multiple gestation, non-cephalic presentation, previous uterine surgery, rupture of membranes, intrauterine fetal death
Impact of Allo-HSCT on Bone Remodeling: Evolution of Bone Mineral Density and Architecture Measured by Bone Densitometry

Evaluation of variation of mineral density and bone microarchitecture after allogeneic HSCTs transplant in hematologic malignancies. Comparison with the general population.

Allo-HSCTs performed for the treatment of hematologic malignancies has been increasing in recent years. There is therefore a growing interest in the quality of life of these patients and in particular for the bone complications of the transplant. Indeed, it was found a high incidence of osteoporosis / osteopenia in this population associated with an increased risk of osteoporotic fracture from 6 to 9 times compared to the general population.

This study will evaluate the variation of mineral density and bone microarchitecture parameters by bone densitometry with measurement of trabecular bone score and fracturing risk before and after allogeneic HSCTs transplant, at predefined times. It's also evaluating pain scale, fracture incidence and bone remodeling markers.

Eligibility Criteria:
Inclusion Criteria:

* Cytological diagnosis of acute myeloid leukemia (AML) with indication for a first-line allo-HSCTs transplant
* Patient affiliated to the social security system
* For women of childbearing age, use of reliable contraception throughout the study in accordance with the CPR of the drugs used.
* The patient must be able to comply with study visits and per protocol procedures
* Patient who has been informed of the study and has signed his informed consent

Exclusion Criteria:

* Person under guardianship or curatorship, or unable to understand the purpose of the study.
* Hematologic malignancies other than AML
* History of neoplasia with bone involvement (sarcoma, multiple myeloma, metastasis...) and/or any solid cancer less than 5 years old
* History of fracture of the femoral neck prior to the diagnosis of hematologic malignancies
* Known bone involvement related to AML at diagnosis
* Primary or secondary osteoporosis known to the diagnosis of hematologic malignancies
* Corticotherapy \> 3 months at a dose \> 7.5mg/day prior to the diagnosis of hematological disease
* Autograft or anterior allograft
* Pathologies influencing bone metabolism: known inflammatory rheumatism (rheumatoid arthritis, ...), primary hyperparathyroidism, chronic renal failure (GFR \< or = at 30ml / min / 1.73m2)
* Pregnant or lactating woman