cyrilzakka/clinical-trials huggingface dataset:
Trial on Treatment of Patients With Primary Hyperoxaluria Type I With Pyridoxal-phosphate

In this study the investigators will prospectively analyze the reduction of urinary oxalate excretion under the treatment with PLP in dosages of 5mg/kg/day up to 20 mg/kg/day and serum level response relationship with PLP as an i.v. solution used orally in 12 patients with primary hyperoxaluria type I as an inherited autosomal-recessive-disorder leading to increased endogenous oxalate production, urolithiasis and end stage renal disease.


Eligibility Criteria:
Inclusion Criteria:

* Documentation of diagnosis of PH I by any one of the following:

  * Liver biopsy confirmation of deficient liver specific peroxisomal alanine-glyoxylate aminotransferase, (AGT or mislocalization of AGT from peroxisomes to mitochondria)
  * Homozygosity or compound heterozygosity for a known mutation in the causative gene (AGXT) for PH I
* Male or female subjects between 5 years and 60 years of age
* Renal function defined as an estimated GFR \> 60 ml/min normalized to 1.73 m2 body surface area
* Subjects receiving pyridoxal-phosphate before the study must be willing to discontinue therapy with pyridoxal-phosphate for a wash out phase of at least 4 weeks but always until normalization of serum pyridoxal-phosphate levels
* Written informed consent from patients and/or legally acceptable representatives

Exclusion Criteria:

* Pregnant or lactating women
* Women of child-bearing potential who are not using a highly effective contraception method with a pearl-index \< 1. Highly effective contraception methods are oral, transdermal, injectable, or implanted contraceptives, IUD, abstinence, or sterile sexual partner and must agree to continue using such precautions during the pyridoxal-phosphate study
* Subjects post liver or kidney transplantation or combined transplantation
* Chronic diarrhoea with the risk of malabsorption
* Any other abnormal finding such as physical examination or laboratory evaluation, in the opinion of the investigator, is indicative of a disease that would compromise the safety taking pyridoxal-phosphate per os and the absorption
* Subjects participating in other clinical trials with investigational products 4 weeks prior to trial entry, during the trial and 4 weeks after the trial
* Subjects who are unable to take the trial medication
* Subjects who are unable to collect 24-hour urine samples or follow other study procedures
* Subjects who are under treatment with L-Dopa, Isoniazid, D-Penicillamine (interactions between these drugs and pyridoxal-phosphate are known and might influence serum pyridoxal-phosphate levels)
* Subjects with known allergies to substances of contents (e.g. Potassium sorbet, raspberry syrup)
* Subjects confined to an institution on judicial or official behalf
* Subjects who are in dependency to the sponsor or the PI of the trial
Using a Text-message System to Engage Depressed Adolescents in Cognitive-behavioral Therapy Homework

The primary goal of the pilot is to test the feasibility and utility of using a text-messaging system to engage adolescents in improved homework adherence during cognitive-behavioral therapy (CBT) for major depressive disorder.

Adolescent major depressive disorder leads to recurrent episodes, increased rates of attempted and completed suicides, and persistent social impairment between episodes (Weissman et al 1999). Cognitive behavioral therapy (CBT) is an accepted first-line therapy for mild-moderate depression in adolescents. Integral to CBT is "homework" as it enhances mastery of newly learned coping strategies, facilitates generalization of skills to novel situations, increases self-efficacy, and ultimately reduces vulnerability to relapse (Detweiler et al 1999). Adherence to homework is a recognized problem in adults, and is similarly problematic in adolescents. One method of implementing CBT homework in a manner that is centric to current youth culture is through text messaging. By using a modern modality that many adolescents rely on for daily communication, there is the likelihood that they will find it more engaging than traditional modalities. Thus the potential that a text message system can help improve homework compliance in adolescents is significant, because improved homework adherence may ultimately be linked to improved clinical outcomes for these disorders with high rates of chronic morbidity and mortality.

Eligibility Criteria:
Inclusion Criteria:

* major depressive disorder
* own a cellular phone with text messaging capabilities

Exclusion Criteria:

* history of psychosis
* history of mental retardation
* active suicidal ideation or intent
Ligamentum Teres Tenodesis in Developmental Dysplasia of the Hip

The treatment of developmental dysplasia of the hip (DDH) remains challenging, yet recent advances have refined our understanding of how best to survey for the condition during infancy, minimize complications during early treatment, and refine the selection of patients who can best benefit from hip preservation surgery. The ideal continued target would be to prevent missed hip dislocations or dysplasia during the infant period, prevent avascular necrosis (AVN) during early treatment, and decrease the incidence of total hip arthroplasty in adulthood related to undertreated DDH, The goal of the treatment is to achieve a concentric reduction of the femoral head into the acetabulum.

it is an operative technique to secure the femoral head after reduction in cases of developmental dysplasia of the hip

Operative technique:

The surgery will be accomplished under a general anesthesia.

An addition to the steps of the open reduction, the following were done:

1. Identification of ligamentum teres
2. ligamentum teres tenodesis

Eligibility Criteria:
Inclusion Criteria:

* Patient with Developmental dysplasia of the hip (DDH) with :

  * Age: from 9 months -5 years old.
  * Virgin DDH.
  * Failed closed reduction in the management of DDH.
  * Failed open reduction through medial approach in the management of DDH

Exclusion Criteria:

* • Paralytic hip dislocation .

  * Post septic hip dislocation.
  * Traumatic hip dislocation .
  * Age : below 9 months or above 5 years.
  * Refusal to participate in this study.
Persistent Poverty Counties Pregnant Women With Medicaid

Although many women initially quit smoking during pregnancy, most will return to smoking by the end of pregnancy or during the first 6 months postpartum. The proposed pilot project is designed to evaluate the feasibility and potential efficacy of offering small financial incentives for the completion of smoking cessation coaching and biochemically-verified smoking abstinence at follow-up among pregnant women with Medicaid insurance who contact the Oklahoma Tobacco Helpline (OTH). The study will enroll 100 pregnant women who will be randomly assigned to OTH care or OTH plus escalating incentives (OTH+I) for completing up to 5 coaching calls over the first 8 weeks after enrolling (prepartum) and for biochemically-verified smoking abstinence at 9 weeks post-enrollment (assessed remotely via smartphone). In addition, participants will be incentivized for completing a postpartum coaching call by 8 weeks postpartum. Feasibility outcomes for the incentives based intervention will focus on coaching call completion, rates of prepartum and postpartum follow-up, biochemically-verified smoking cessation, and perceptions of the intervention. Potential effectiveness will be evaluated by comparing biochemically-verified smoking abstinence rates in OTH+I relative to OTH alone at 12 weeks post-enrollment (prepartum) and 12 weeks postpartum.


Eligibility Criteria:
Inclusion Criteria

* contact the Oklahoma Tobacco Helpline seeking smoking cessation treatment, and enroll in the multiple call program
* are a female ≤ 25 weeks pregnant
* report smoking ≥ 5 cigarettes per day
* are ≥ 18 years of age
* are able to provide a copy/photo of their ID/driver's license or other documentation of identity
* are able to read, speak, and understand English

Exclusion Criteria

• participants will be excluded if they do not meet the inclusion criteria
Observational Study of Dydrogesterone in Cycle Regularization

Dydrogesterone has been widely used worldwide for various gynecological and obstetric indications:

* Dydrogesterone is effective in cycle regulation treatment.
* Dydrogesterone is recognized as none interference to hypothalamus pituitary ovary (HPO) axis in the recommended dosage.
* Dydrogesterone might have non-negative effect on glucose and lipid metabolic.

The current study is designed as a prospective, non-interventional, observational study. Patients with irregular cycle diagnosed as AUB-O will be prescribed dydrogesterone as per physician's clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Women aged 16 years or above with menses
* Patient who is suffering from irregular menstrual cycle for at least 3 months and has been diagnosed as AUB-O (irregular cycle is defined as cycle duration \< 21days or \>35 days)
* Physicians have decided to prescribe dydrogesterone 10mg for cycle regulation treatment, orally taking dydrogesterone 10mg twice daily, from day16 to day 25 of each cycle, being consecutive at least 3 cycles
* Patient who is willing to sign written authorization

Exclusion Criteria:

* Hyperprolactinemia and thyroid dysfunction.
* Patient took cycle regulation treatment including oral contraceptives, sex hormone or glucocorticoid in the past 1 month
* Women with estrogen deficiency related symptom
* Patient who meets the contraindications listed in Chinese label of dydrogesterone
* Pregnant and lactating patients
* Patient who is not suitable for the study according to physician's discretion
Safety, Tolerability and Pharmacokinetics Study of CK-3773274

The purposes of this study are to:

1. Learn about the safety of CK-3773274 after a single dose and multiple doses in Chinese healthy adult subjects.
2. Learn how healthy subjects tolerate CK-3773274 after a single dose and multiple doses.
3. Find out how much CK-3773274 is in the blood after a single dose and multiple doses.
4. Determine the effect of doses of CK-3773274 on the pumping function of the heart.
5. Evaluate the effect CYP2D6 genetic polymorphisms on how the body metabolizes CK-3773274.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy Chinese males and females between 18 and 45 years of age, inclusive
2. Body weight ≥50kg and body mass index (BMI) within 18 to 26 kg/m2, inclusive
3. Acoustic windows adequate for accurate transthoracic echocardiograms
4. Normal cardiac structure and function, as determined by the cardiologist, or if abnormalities are present, the finding is not clinically significant as determined by the cardiologist
5. LVEF ≥65 percent at screening, and LVEF ≥60 percent at Day-1
6. Normal ECG

Exclusion Criteria:

1. History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs
2. Subjects with breast implants that may impede echocardiography
3. A clinically significant illness within 4 weeks prior to admission to the CRU
4. Inability to swallow tablets
5. Use of alcohol-containing, grapefruit-containing, or caffeine-containing foods or beverages within 48 hours prior to admission to the CRU
6. Poor peripheral venous access
7. Any blood donation within 60 days prior to admission to the CRU, or any plasma donation within 30 days prior to admission to the CRU, or receipt of blood products within 2 months prior to admission to the CRU
A Study to Evaluate Nivolumab in Japanese Participants With Muscle-invasive Urothelial Carcinoma

The purpose of this study is to evaluate the effectiveness, safety, and actual treatment status of nivolumab administered as an adjuvant treatment for participants with muscle-invasive urothelial carcinoma (MIUC), including bladder, renal pelvis, and ureteral cancer, in a Japanese real-world clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Must have a histologically definitive diagnosis of MIUC at each study site and who must have received nivolumab after radical resection
* Must present at least once to the study site after nivolumab treatment or must have survival data

Exclusion Criteria:

* Participants who underwent only partial resection for MIUC
* Participants treated with chemotherapy, radiotherapy, biologics (anticancer agents), intravesical chemotherapy, or Bacillus Calmette-Guérin therapy from the time of radical resection of MIUC to the start of nivolumab
* Participants previously treated with immune checkpoint inhibitors prior to nivolumab treatment

Other protocol-specific inclusion/exclusion criteria apply.
Role of Frontal Cortex in the Pathophysiology of Gilles de la Tourette Syndrome (GTS)

Tourette's syndrome (TS) is a debilitating and severe syndrome whose pathophysiology remains unclear.

In order to precise the cortical regions involved in the generation of tics, investigators will realize an electroencephalogram (EEG) recording in the frontal cortex of TS patients in ecological conditions (EEG-holter). Activity changes will be correlated with event markers of tics and neurovegetative parameters. Statistical analyses will be compared between epochs of EEG recording with tics and without tics. The aim is to define the cortical regions involved in the genesis of tics in order to consider new targets for cortical stimulation.

Gilles de la Tourette syndrome (GTS) is a childhood-onset disorder characterized by the presence of multiple motor tics and at least one vocal tic often associated with psychiatric co-morbidity. The expression of tics range from brief, recurrent and non-rhythmic motor or vocal actions (simple tics) to complex motor or vocal sequences (complex tics). The pathophysiology of tics is not yet fully understood. Recent imaging data suggest that the pattern of functional connectivity in cortico-basal ganglia networks is disrupted in GTS patients and could reflect a defect in brain maturation. However, regions involved in the immediate genesis of tics remains unknown since it is difficult to capture on line the cortical changes associated with tic generation using imaging techniques due to moving artefacts. Moreover, tics are much more frequent in everyday life conditions than in the artificial conditions of a laboratory. The aim is to study cortical activity changes occurring before tic occurrence by using long duration recording of encephalographic activity (EEG) in ecological conditions through Holter EEG techniques (24h recordings). Recordings will be performed in 15 patients with a severe form of Tourette's syndromes. EEG changes will be correlated to event markers, voluntary monitored by patients or automatically recorded (accelerometers for motor tics). EEG epoch centered on tics will be compared to similar epochs without tics. The occurrence of tics will also be correlated with neurovegetative markers of emotions such as RR interval ECG variability and skin resistivity changes. The ultimate goal of this project is to define a potential therapeutic target of tics for chronic cortical stimulation.

Eligibility Criteria:
Inclusion Criteria:

* Tourette's syndrome since at least 2 years
* Lack of psychiatric comorbidity of axis 1 (depression)
* Y-YSGT score \> 20
* Social insurance in accordance with the french law

Exclusion Criteria:

* Epilepsia
* Patient with an implanted medical device
* Severe mental or somatic disease
* Risk of suicide,
* Pregnant or breast feeding women
* Patient under "curatelle" or "tutelle"
* Patient hospitalized

no social insurance
Autoimmune Phenomena After Acute Stroke

The damage of the brain parenchyma, as well as the stroke-induced dysfunction of the blood-brain-barrier can make previously hidden CNS antigens "visible", and can thus lead to the development of autoimmune mechanisms.

It seems plausible that stroke-associated immunodepression influences the development and the phenotype of these autoreactive immune responses.

This study will investigate whether cerebral ischemia leads to changes in the immune response, in particular to the development and/or proliferation of autoreactive effector T-cells and/or regulatory T-cells. Furthermore, the association between the severity and the phenotype of this autoimmune response and the clinical course, i.e. prognosis and mortality, will be investigated.


Eligibility Criteria:
Inclusion Criteria:

* acute media infarct or intracerebral bleeding within the last 36 h (patients)
* NIHSS \> 7 (patients)
* age \> 17 years (patients), age \> 54 years (controls)
* informed consent of patient or legal representative/ of control
* cardiovascular risk such as diabetes mellitus (control)

Exclusion Criteria:

* infections (patients, controls)
* antibiotic or immunosuppressive treatment within the last 4 weeks (patients)
* other CNS disorders
Feasibility of Pre Transplant Exercise (Pre-habilitation) for Multiple Myeloma Patients Awaiting Autologous Stem Cell Transplantation

The investigators propose to determine whether it is acceptable to patients with a diagnosis of multiple myeloma (a type of blood cancer that can cause bone weakness, pain and fatigue) to be offered and attend an exercise group before receiving an autologous stem cell transplantation (being given back one's own stem cells, following receipt of intensive chemotherapy, to enable bone marrow to start producing blood cells again). Exercise has been shown to be effective in reducing many of the side effects of myeloma and the treatment patients receive to manage the disease. Prehabilitation i.e. providing an intervention after diagnosis but before treatment begins has been effective in reducing the severity of side effects of treatment in cancer patients receiving surgery. No evidence exists for its use in patients with myeloma. Patients awaiting transplantation will be provided with information regarding the study and invited to join. Patients who agree to take part will attend the hospital for an assessment of their exercise capability and to complete one set of four questionnaires. They will receive an exercise booklet, advice and complete one attempt at their exercise programme under supervision of a physiotherapist. Patients will be requested to attend the gym for a minimum of six further weeks to complete their exercise programme. Patients will complete a repeat set of questionnaires and a repeat walking test six weeks after the first, on admission to hospital for their transplant and on the day they leave hospital. Some patients will be invited to discuss their opinions of the exercise programme and how useful they felt it was to them in preparing for their transplant. If the study shows that the exercise programme is acceptable to patients and we can recruit enough patients to test it in a larger trial, the investigators will apply for further funding.


Eligibility Criteria:
Inclusion Criteria:

* All patients will have a diagnosis of multiple myeloma and assigned to the autologous transplantation waiting list for either a first or second transplant

Exclusion Criteria:

* History of unstable angina or a heart attack in the previous month to allow safe completion of the six minute walk test.
* Medical stability is a pre-requisite for transplantation so no patients would be excluded on this basis.
Cosmetic Outcomes of Umbilical Hernia Incisions

This will be a single institution, prospective, randomized controlled trial. Patients presenting as an outpatient for repair of umbilical hernias who meet our inclusion criteria, whose parents provide permission to participate in the study, will receive the umbilical hernia repair that they are randomized to. The appropriate data will be collected on day of surgery, and patients will be followed with a delayed parental submission of incisional photograph.


Eligibility Criteria:
Inclusion Criteria:

* Patient presenting with umbilical hernia that is \<1.5cm in size based on physical exam for outpatient repair
* Treated at CMH Adele Hall or CMHK from 09/11/24 - 09/11/25
* Subjects \<10 years of age

Exclusion Criteria:

* Umbilical hernia \> 1.5 cm in size
* Patients with prior umbilical surgery
* Subjects ≥10 years of age
Safety of SPD417 Combined With Other Psychotropic Medications in the Treatment of Bipolar I Disorder

The purpose of this study is to evaluate the safety of SPD417 when given with other psychotropic medications to treat bipolar I disorder.


Eligibility Criteria:
Inclusion Criteria:

* DSM-IV criteria for Bipolar I disorder
* Screening YMRS score =\>16
* Women of childbearing potential agree to take adequate precautions against contraception
* Currently receiving treatment with antipsychotic therapy or combination therapy of mood stabilizer and antipsychotic

Exclusion Criteria:

* Hospitalization required for treatment of psychiatric symptoms
* Patients who meet DSM-IV for ultra-rapid cycling
* History of serious suicide attempt requiring medical intervention
* Female subjects who are pregnant or lactating, including females with a positive pregnancy test at screening
Investigation of the Effects of Different Exercise Programs in Patients With Restless Legs Syndrome.

Restless leg syndrome (RLS) is a very common neurological condition characterized by an uncontrollable desire to move the legs. Due to the traumatic effect of RLS on morbidity, the patient is negatively affected in many different directions. The duration and quality of sleep of the patients decrease, and their cognitive functions change. The prevalence or risk of anxiety and depression increases in this population. At the same time, the quality of life of patients is significantly reduced. Among the different pharmacological agents used in RLS, dopamine agonists are the most widely used. However, the reporting of serious and common side effects related to this treatment has led to non-pharmacological approaches in the treatment of RLS and the effectiveness of many different approaches has been investigated. The exercise approach, which is determined to be effective in the treatment of the disease, is a subject that has been little studied. The type, duration and frequency of optimal exercise could not be standardized. In addition, the effect of exercise on RLS patients has been investigated in limited subjects. For this reason, the aim of our study is to examine the effect of different exercise programs on symptoms, sleep, cognitive functions, quality of life, psychological status and fatigue in patients with RLS.


Eligibility Criteria:
Inclusion Criteria:

* Having been diagnosed with RLS according to the International Restless Legs Syndrome Study Group 2014 criteria
* Being over the age of 18
* Being literate
* Not having received any treatment for RLS, discontinuing treatment, or continuing symptoms despite current treatment.

Exclusion Criteria:

* Having any of musculoskeletal disorders that prevent physical activity
* History of ischemic heart disease (recent myocardial infarction or unstable angina, uncontrolled hypertension)
* Liver dysfunction
* Kidney dysfunction
* Anemia
* Diagnosis of another sleep disorder
* Diagnosis of gastrointestinal disease (irritable bowel syndrome, Crohn's disease, ulcerative colitis etc.)
* Pregnancy
* History of psychiatric, psychoactive, antidepressant medication use
* History of malignancy
Dose Reduction in Thoracic CT

Hypothesis: Does a 50% reduction in radiation in dose significantly affect the diagnostic quality of chest CT

Patients with Lymphoma are recruited and have a follow up CT performed at 50% of the standard exposure parameters. The studies are compared for image quality with a recent (\<3 months) thoracic CT performed at standard exposure parameters.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Lymphoma

Exclusion Criteria:

* No recent (\<3 months) thoracic CT