cyrilzakka/clinical-trials huggingface dataset:
Effect of Mizagliflozin Repeat Dosing on Adverse Events and Postprandial Glucose Excursions

This is a phase 2 crossover, randomized, placebo-controlled, single-blind, repeat dose study in PBH subjects to determine the effect of mizagliflozin on adverse events and postprandial glucose excursions.

This is a phase 2 crossover, randomized, placebo-controlled, single-blind, repeat dose study in PBH subjects to determine the effect of mizagliflozin on adverse events and postprandial glucose excursions. This study will examine repeat doses of mizagliflozin and placebo while also evaluating dosing regimen. Up to 15 subjects are expected to complete the study. Subjects will be randomly assigned to a treatment arm within a cohort. Each subject should receive placebo and 2 active dose regimens in a crossover fashion.

Eligibility Criteria:
Inclusion Criteria:

* Roux-en-Y gastric bypass surgery performed \> 6 months prior to enrollment
* Diagnosis of PBH

Exclusion Criteria:

* History of current medical conditions (other than PBH) which may result in hypoglycemia such as insulinoma, adrenal insufficiency, insulin autoimmune hypoglycemia, congenital hyperinsulinemia.
* Current use of insulin or insulin secretagogues
* History of current fasting hypoglycemia
* Pregnancy and/or lactation: For women of childbearing potential: there is a requirement for a negative urine pregnancy test and for agreement to use contraception during the study and for at least 2 weeks after participating in the study
Memantine Treatment of Compulsive Buying

This is an 8-week, open-labe study of memantine in the treatment of compulsive buying.

The goal of the proposed study is to evaluate the efficacy of memantine in the treatment of compulsive buying. Sixteen subjects meeting criteria for compulsive buying will receive 8 weeks of open-label memantine. The hypothesis to be tested is that memantine will be effective and well tolerated in patients with compulsive buying. The proposed study will provide needed data on the treatment of a disabling disorder that currently lacks a clearly effective treatment.

Eligibility Criteria:
Inclusion Criteria:

1. men and women age 18-65
2. current CB using the clinician-administered Structured Clinical Interview for Compulsive buying (SCI-CB)
3. buying behavior within 2 weeks prior to enrollment

Exclusion Criteria:

1. infrequent buying (i.e. less than one time per week) that does not meet proposed criteria for CB
2. unstable medical illness or clinically significant abnormalities on laboratory tests or physical examination at screen
3. history of seizures
4. myocardial infarction within 6 months
5. current pregnancy or lactation, or inadequate contraception in women of childbearing potential
6. a need for medication other than memantine with possible psychotropic effects or unfavorable interactions;
7. clinically significant suicidality;
8. current Axis I disorder determined by the SCID and SCID-compatible modules for impulse control disorders, except for nicotine dependence
9. lifetime history of bipolar disorder type I or II, dementia, schizophrenia, or any psychotic disorder determined by SCID
10. current or recent (past 3 months) DSM-IV substance abuse or dependence;
11. positive urine drug screen at screening
12. initiation of psychotherapy or behavior therapy within 3 months prior to study baseline
13. previous treatment with memantine
14. treatment with investigational medication or depot neuroleptics within 3 months, with fluoxetine within 6 weeks, or with other psychotropics within 2 weeks prior to study baseline
Evaluate Long-term Safety, Tolerability and Efficacy of Iptacopan in Study Participants With aHUS

This is a multicenter, single arm, open-label, extension study to evaluate the long-term safety, tolerability, and efficacy of iptacopan in participants with aHUS.

The extension study Baseline/Day 1 visit is equivalent to the End of Treatment visit of the parent study. The study will begin on Day 1 followed by on-site visits every 4 months during the study treatment period. A Safety Follow Up tele-visit must be conducted 7 days after last study treatment to collect information on Adverse Events.

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent must be obtained prior to participation in the open label extension study
2. Willing and able to comply with the study Schedule of Activities
3. Participants who have completed the full study treatment period of any prior "Novartis sponsored" iptacopan Phase 3 clinical trial in aHUS, are still on iptacopan study treatment and derive benefit from it as per Investigator's judgement
4. Prior vaccinations against Neisseria meningitidis, Streptococcus pneumoniae and Haemophilus influenzae infections should be up to date (i.e., any boosters required should be administered according to local guidelines)

Exclusion Criteria:

1. Concomitant treatment with any complement inhibitor as well as concomitant treatment with any of the prohibited drugs
2. Any comorbidity or medical condition (including but not limited to any active systemic bacterial, viral or fungal infection or malignancy) that, in the opinion of the Investigator could put the participant at risk
3. Active infection or history of recurrent invasive infections caused by encapsulated bacteria such as Neisseria meningitidis, Streptococcus pneumoniae or Haemophilus influenzae
4. History of hypersensitivity to iptacopan or its excipients or to drugs of similar chemical classes
5. Pregnant or nursing (lactating) women
6. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of investigational drug and for 1 week after stopping of investigational drug.

Other protocol-defined inclusion/exclusion criteria may apply.
Home Care Management of Pediatric Pain

The purpose of this study is to determine whether around-the-clock dosing of pain medication, with or without nurse coaching, increases the effectiveness of pain management (i.e., decreased pain intensity scores with and without swallowing, increased use of pain medication, improved sleep, increased oral intake of fluids, decreased negative behaviors, and the same degree of side effects), over time, compared to standard care with "as needed" dosing.

The undertreatment of postoperative pain in children remains a critical problem. Only recently have clinical trials begun to evaluate the efficacy of pharmacologic interventions in the management of postoperative pain beyond the immediate postoperative recovery period and after discharge home following tonsillectomy. Given the fact that approximately 50% of pediatric surgeries are done on an outpatient basis, this study has the potential to improve the home pain management of thousands of children. This study is one of the first to evaluate in a systematic fashion the use of an around-the-clock dosing of a weight appropriate dose of a nonopioid/opioid combination analgesic compared to as needed dosing. Because the study will evaluate the effectiveness of both a behavioral intervention and two different pharmacologic interventions, it will provide important information that should have a direct clinical application in the management of children's pain.

The consent form is written according to the standards outlined by the Committee on Human Research, including: 1) an explanation of the purposes of the research and the expected duration of the subject's participation; 2) a description of the procedures to be followed; 3) a description of any foreseeable risks or benefits to the subject, and any alternative courses of treatment; 4) a statement describing the extent to which confidentiality of records will be maintained; 5) a statement whether compensation will be provided and medical treatment made available if injury occurs; 6) the name and number of the Chair of the Committee on Human Research; 7) a statement that participation is voluntary, and that the subject may discontinue participation at any time; and 8) a statement indicating that the subject has received a copy of the consent document and related materials. A separate form is signed to authorize access to their health care information.

Eligibility Criteria:
Inclusion Criteria:

* Outpatient tonsillectomy, with or without other minor procedures (e.g., ear tube placement); parental consent; child assent (age-appropriate); ability of the child to speak English; ability of the parents to read, write, and speak English; and, access to a telephone.

Exclusion Criteria:

* History of severe obstructive sleep apnea (causing the child to stop breathing repeatedly during sleep); known problems with vision, hearing, control and coordination of movement, or thinking ability.
Prognostic Value of Anti-Ro52 Antibodies in Connective Tissue Diseases (a-Ro52)

Anti-Ro52 autoantibodies can be detected in patients with several autoimmune diseases. Clinical significance of anti-Ro52 is controversial. The presence of anti-Ro52 may be a factor associated with disease severity (interstitial lung disease, vasculopathy) and cancers. The aim of this study is to assess interstitial lung disease and vasculopathy prevalence and severity, cancers occurence and others clinical features of connective tissue disease patients with anti-Ro52 autoantibodies.


Eligibility Criteria:
Inclusion Criteria:

* Connective tissue disease (differenciated or not)
* Presence of anti-Ro52 antibodies at diagnosis

Exclusion Criteria:

* Healthy subjects
Effects of Different Doses of Pinitol on Carbohydrate Metabolism Parameters in Healthy Subjects

The purpose of this study was to assess the acute effects of increasing doses of pinitol on glucose tolerance and insulin sensitivity and to evaluate the absorption of pinitol after consumption of an oral nutritive pinitol-enriched beverage in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria for all subjects were age range of 18-65 years, body mass index of 20-30 Kg/m2 and clinically normal kidney function, liver function, heart function, protein status and haematological profile.

Exclusion Criteria:

* Exclusion criteria were pregnancy or lactation, alteration of carbohydrate metabolism, fasting glycaemia ≥5.55 mmol/l on at least two previous occasions, diabetes, or medication known to interfere with glucose metabolism.
Beyond Performance Status: Electronic Activity Monitoring to Assess Functional Activity of Patients With Gastrointestinal Malignancy During Chemotherapy.

Electronic activity monitoring (EAM) devices are wearable electronic devices that monitor functional activity and provide personal feedback on activity progression. This study aims to determine if EAM can provide an objective, assessment of patient functional activity. The study will also examine the change in functional activity experienced by patients during the first cycle of chemotherapy. Another objective of the study will be to see if baseline functional activity and the change in functional activity that occurs during the first cycle of chemotherapy can be used to predict patient tolerability of subsequent cycles of chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of gastrointestinal malignancy.
* Age ≥ 18 years
* Planned to receive systemic chemotherapy, either adjuvant chemotherapy, or neoadjuvant chemotherapy, or any new line of chemotherapy in the setting of advanced disease. Subjects may enroll prior to chemotherapy or during the first cycle of treatment.

Exclusion Criteria:

* Restricted mobility defined as dependence or anytime use of a walker or wheelchair in the past three months.
* Refusing systemic chemotherapy.
* Concurrent radiotherapy with chemotherapy
* Have received at least one cycle of chemotherapy in the current chemotherapy regimen.
Zonisamide Versus Topiramate in Migraine

Investigators aim to compare the effect of zonisamide versus topiramate in migraine by assessing the absolute reduction in MMD in each group, the percentage of patients who achieved ≥ 50% reduction in the monthly headache days frequency compared to the baseline frequency

Investigators will enroll 600 migraine patients who are diagnosed according to ICHD3-beta criteria in our study and will use a questionnaire to detect their demographic and clinical features (disease duration, attack frequency, and duration, pain intensity assessed by the visual analogic scale and we have two groups the first group will include 300 patients and will receive 100mg zonisamide daily and Acetaminophen 500-1000 mg in acute attack, and the second group will receive topiramate100 mg per day and Acetaminophen 500-1000 mg in acute attack for at least three months. Investigators will assess The number of migraine days after three months of treatment and the percentage of patients who achieved ≥ 50% reduction in the monthly headache days frequency compared to the baseline frequency. HIT-6 score reduction in each group after three months of treatment. The safety of lacosamide was evaluated by monitoring and documenting treatment-emergent adverse events (TEAE) in patients through regular follow-up procedures for three months.

Eligibility Criteria:
Inclusion Criteria:

* migraine patients, according to the International Classification of Headache Disorders 3rd edition,
* age from 10 to 55 years,

Exclusion Criteria:

* Patients with major neurological disorders such as ( epilepsy, ischemic or hemorrhagic stroke, multiple sclerosis, mitochondrial diseases, brain tumors, and patients with essential tremors.
* patients with major systemic diseases such as malignancy, collagen, liver, and renal diseases.
* Patients with cardiovascular diseases, such as hypertension (systolic blood pressure of more than 130 and/or diastolic blood pressure of more than 85 mm/Hg on at least three different occasions), diabetes (fasting plasma glucose level \>126 mg/dl and/or casual plasma glucose \>200 mg/dl), and/or HbA1C more than 6.5.
* Patients with valvular and ischemic heart diseases, bradycardia or heart blocks, congestive heart failure patients who received prophylactic treatment for migraine, patients with any contraindications to drugs used in the study patients with bronchial asthma, chronic obstructive pulmonary disease
Phase I/IIA Study of PET Imaging With 89Zr-Df-IAB2M in Metastatic Prostate Cancer

This is a Phase I/IIa study evaluating the safety and feasibility of \[89Zr\]Df-IAB2M as an immunoPET tracer for metastatic prostate cancer. Individuals participating in this study will have a FDG PET scan, as well as four (4) PET scans (over a 3 day period) following the injection of \[89Zr\]Df-IAB2M PET tracer. Three different dosing levels will be explored. The purpose of the study is to demonstrate the safety of \[89Zr\]Df-IAB2M, ability to detect prostate cancer, and optimal time point and dose level for imaging.

IAB2M is an approximately 80 kDA molecular weight antibody fragment (a "Minibody"). Limited (Phase 0/Proof-of-concept) patient experience with this biologic targeting agent has been previously obtained with SPECT imaging Ex-US, demonstrating targeting of soft tissue and bone lesions in advanced metastatic prostate cancer.

Eligibility Criteria:
Inclusion Criteria:

* Adult male \>/= 18 years of age
* Patients with histologically confirmed prostate cancer
* Progressive disease manifest (within 6 weeks of screening) by either

  * imaging modalities (bone scan, MRI or CT) OR
  * biochemical progression (PSA)
* Performance status of 60 or higher on Karnofsky scale
* Subject's schedule permits compliance with all study procedures
* Ability to understand and willingness to sign a written informed consent form

Exclusion Criteria:

* Previous anaphylactic reaction to huJ591 antibody or FDG imaging
* On any new anticancer therapy (GnRH analog allowed) while on the study
* Hepatic lab values: Bilirubin\>1.5 ULN; AST/ALT \>2.5 ULN; Albumin \< 2 g/dL; GGT \> 2.5 ULN if Alkaline Phostphatase \>2.5 ULN
* Renal lab values: Creatinine \> 1.5 ULN
* Other severe acute or chronic medical condition that may increase the risk associated with study participation or investigational product administration
Effects of Virtual Reality System in Children With Developmental Delays

The purpose of this study is to investigate the effects of virtual reality system on children with developmental delays.

Participants attended eight 30-minute sessions of virtual reality system for 4 weeks in addition to regular rehabilitation programs.

Eligibility Criteria:
Inclusion Criteria:

* confirmed to have developmental delays
* provided informed consent
* 2 to 12 years old

Exclusion Criteria:

* failed to provide informed consent
Using Light Therapy to Treat Toe Nail Fungus

To see if four sessions of light therapy successfully treats nail fungus.

This study is a one year study which includes four treatment sessions of light therapy looking for clinical and mycological improvement.

Eligibility Criteria:
Inclusion Criteria:

* toe nail fungus, not infolving lunula
* between ages 18-70 years old

Exclusion Criteria:

* not on systemic anti-fungal medications
Comparison of Atorvastatin and Pitavastatin on the Effect of HbA1c in AMI Patients With Abnormal Glucose Metabolism

Different types of statins show different influences on glycometabolism. There are no systemic analyses of the effects that statins exert on the metabolism of glucoses so far in China. This research aims to compare impacts on the glycometabolism of pitavastatin in AMI patients with atorvastatin and to accumulate data for guiding the utilization of statins.

General study design:

This study is a prospective, multicenter, open and randomized controlled clinical trial, which utilize online registration database of CAMI to do the enrollment, randomization and follow-up. We will select 14 of the centers to compete into the group. The researchers used a central randomized distribution system to prescribe medication for patients. Follow the method of drug administration approved by the state drug administration department, we will estimate the efficacy and safety of treatment at the following timing: baseline, one month and six months after treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Newly diagnosed acute myocardial infarction.
2. Diabetes or pre-diabetes.
3. The patient signed informed consent.

Exclusion Criteria:

1. A clear history of chronic liver disease, or abnormal liver function (ALT/AST\>1.5×ULN).
2. There is evidence of active inflammatory myopathy or CK\>3×ULN.
3. Being allergic to statins or severe side effects were caused by taking statins(including myolysis).
4. Combined with hypothyroidism, nephrotic syndrome, alcoholism, pancreatitis, lupus erythematosus.
5. All patients who had a clear adverse reaction to the statins.
6. Possibility of pregnancy, pregnant or lactating patients.
7. There may be limited medical history of subjects who may can not complete their treatment during the study period.
8. Undergoing or planning to functional renal transplantation.
9. The life expectancy is no more than half a year.
10. Patients who are taking birth control pills, steroid hormones and imidazole drugs.
11. Patients who have participated in clinical trials of other drugs within 1 month, or known that clinical follow-up or research on drug compliance poorly.
12. Patients are not fit to be tested according to the researchers.
Comparison Between Rapid and Slow Palatal Expansion: Evaluation of Periodontal Indices

The aim of this study is to evaluate the periodontal effects during rapid palatal expansion (RPE) or slow palatal expansion (SPE) and to compare them by means of periodontal indices, in order to establish the possible differences and advantages of one of these treatments in periodontal terms.

Materials and methods: 10 patients will selected and submitted to RPE treatment; other 10 patients will selected and submitted to SPE treatment. The patients will treated with the Haas appliance. In both the groups the periodontal clinical indices (plaque index, PI; papillary bleeding index, PBI; probing pocket depth, PPD) will collected three times during the treatment (before, during and at the end). All measurements will performed by the same examiner.

A descriptive statistical analysis will conducted. The paired samples Student's T test will used to evaluate the intra-group differences between t1 and t2. The unpaired samples Student's T test will used to evaluate between groups differences at t1 and t2. The significance level will set at 95%.


Eligibility Criteria:
Inclusion Criteria:

* palate narrow
* necessity of performing a expansion treatment

Exclusion Criteria:

* dental disease
Optimal Transfusion in Anaemic Cancer Patients Treated With Chemotherapy (HaemOPtimal)

This an open two-arm interventional randomised feasibility study in anaemic patients treated with chemotherapy. Randomisation is performed between two transfusion thresholds: Haemoglobin \< 6.0 mmol/l (9.9 g/dL) versus haemoglobin \< 7.1 mmol/l (11.7 g/dL) for female and 8.1 mmol/l (13.4 g/dL) for males.Primary end-point is quality of life

Title:

Randomised Feasibility Study of Optimal Transfusion Thresholds in Anaemic Cancer Patients Treated with Chemotherapy (HaemOPtimal)

Background:

Cancer patients treated with chemotherapy very often become anaemic, which have profound negative impact of their quality of life. Blood transfusions can ameliorate symptoms caused by anaemia. Data are lagging with regard to what threshold should be used when offering blood transfusion.

Aim:

The primary aim is to determine which end-points reflect symptoms caused by anaemia in cancer patients treated with chemotherapy. The secondary aims are to collect data to estimate sample size in a future definitive study and to compare symptom relief using to different transfusion thresholds.

End-points:

* Numeric Rating Scale measuring fatigue, dizziness, palpitations, headache, and dyspnea.
* FACT-G,
* FACT-An (Total anemia scale) including a fatigue subscale
* Patient-assessed WHO performance status

Design:

Open two-arm interventional randomised feasibility study

Intervention:

* Blood transfusion.
* Randomisation between two transfusion thresholds:

Haemoglobin \< 6.0 mmol/l (9.9 g/dL) versus Haemoglobin \< 7.1 mmol/l (11.7 g/dL) for female and 8.1 mmol/l (13.4 g/dL) for males.

Population:

Cancer patients treated with chemotherapy

Inclusion criteria:

* Documented cancer
* Planned treatment with chemotherapy
* Age 18 years or older
* Informed consent

Exclusion criteria:

* Heart failure (NYHA 3 and 4)
* Prior serious complications to blood transfusion
* Medical conditions that require special considerations for blood transfusion
* Treatment with erythropoiesis-stimulating agents.

Number of patients:

Transfusion of at least 30 patients in each intervention arm. An estimated number of 90 patients will be randomised in each arm (180 in total) as a third of included patients are expected to require transfusion.

Eligibility Criteria:
Inclusion Criteria:

* Documented cancer
* Planned treatment with chemotherapy
* Age older than 18 years
* Informed consent

Exclusion Criteria:

* Heart failure (NYHA 3 and 4)
* Prior serious complications to blood transfusion
* Medical conditions that require special considerations for blood transfusion
* Treatment with erythropoiesis-stimulating agents