cyrilzakka/clinical-trials huggingface dataset:
Alport Syndrome Treatments and Outcomes Registry

ASTOR's primary purpose is to enroll families and patients with a history of Alport syndrome in a central registry. The information we gather will be used as a basis for studies designed to test potential treatments for Alport syndrome. ASTOR also aims to provide patients, families and physicians with the most up-to-date information about Alport syndrome.

The University of Minnesota's Department of Pediatrics has created the Alport Syndrome Treatments and Outcomes Registry (ASTOR). ASTOR's primary purpose is to enroll families and patients with a history of Alport syndrome in a central registry. The information we gather will be used as a basis for studies designed to test potential treatments for Alport syndrome. ASTOR also aims to provide patients, families and physicians with the most up-to-date information about Alport syndrome.

You can help doctors learn more about Alport syndrome and test possible treatments for the disease by enrolling in ASTOR. Since Alport syndrome is a rare disease it is essential for ASTOR to enroll as many patients as possible. Together, you and others facing the challenges of Alport syndrome can provide valuable information that will help doctors better understand the disease and in turn, help patients with Alport syndrome now and in the future.

Eligibility Criteria:
Inclusion Criteria: History of a diagnosis of Alport syndrome, Family or individuals need to be able to comprehend the consent and HIPAA forms written in the English language.

Exclusion Criteria: Uncertain diagnosis of Alport syndrome.
Effect of Roflumilast at Acute Exacerbations of Chronic Obstructive Pulmonary Disease

The purpose of this trial is to investigate if roflumilast can reduce the neutrophilic inflammation at acute exacerbations of Chronic Obstructive Pulmonary Disease (COPD). In addition, the potential benefit of roflumilast on severity and recovery periods of acute COPD exacerbations will be assessed using patient diaries and questionnaires.

Participants will be asked whether they agree to participate in the measurements of arterial stiffness. Participants who agree will be included in the substudy, with the target of 60 patients with arterial stiffness measurements to complete the trial.

Study was terminated due to difficulty in identifying further eligible patients for this exploratory study within a reasonable time.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent (IC)
* Age ≥ 40 years
* History of COPD for at least 12 months prior to enrollment (Visit V0)
* Chronic productive cough for 3 months in each of the 2 years prior to enrollment (if other causes of productive cough have been excluded) and/or an exacerbation with predominantly bronchitic symptoms at enrollment
* Presentation of an acute exacerbation of COPD that will be associated with increased sputum volume or change in sputum colour
* Documented fixed airway obstruction determined by an FEV1/FVC ratio (post-bronchodilator) \< 70% (if a pulmonary function test is not possible at Visit V0 a previous measurement can be taken which must not be older than 6 months)
* Former smoker (defined as: smoking cessation at least 1 year ago) or current smoker both with a smoking history of at least 10 pack years

Main Exclusion Criteria:

* Diagnosis of asthma and/or other relevant lung disease
* Known alpha-1-antitrypsin deficiency
* Recurrent exacerbations (within 8 weeks of a preceding exacerbation)
* Treatment of current exacerbation with oral corticosteroids and/or antibiotics already started at enrollment
* Treatment with PDE4 inhibitors within 3 months prior to Visit V0
* Other protocol-defined exclusion criteria may apply
OnabotulinumtoxinA for Trigeminal Neuralgia

A randomized controlled trial comparing Onabotulinumtoxin A to saline (placebo) for Trigeminal Neuralgia.

This study will offer onabotulinumtoxin A (Botox) delivered intradermally into the region of pain for the patient with trigeminal neuralgia. Should they derive benefit from the procedure (as determined by decrease in the frequency of attacks), then they will be randomized to receive either onabotulinumtoxin A or saline and followed for 3 months. This study hopes to provide strong data that this is a treatment option for patients with TN who have failed medications, but are not ready for or do not want to undergo surgery.

Eligibility Criteria:
Inclusion Criteria:

Men and women age 18 or older

* Judged to be of legal competence
* Sufficient knowledge of written and spoken English
* Capable of attending regular in-person visits
* Have failed/not a candidate/do not want surgery
* Inadequate response to medication - at least 2 trials
* Meeting ICHD criteria for Classical Trigeminal Neuralgia 13.1.1.1
* Patients with frequency \> 10 attacks per week
* Stable dose of medications in the last 2 weeks

Exclusion Criteria:

* Secondary or Idiopathic TN, or Painful Trigeminal Neuropathy as defined by the ICHD (13.1.1.2, 13.1.1.3, 13.1.2)
* Pregnant or breast feeding (while it is rare that a patient will be pregnant with TN, there is not sufficient data to say definitively that onabotA is ok to use during pregnancy and nursing, it is still rated Class C)
* Neuromuscular disease
* On aminoglyocosides
* Not currently enrolled in any other studies
Study of Alvimopan for the Management of Opioid-induced Postoperative Bowel Dysfunction/Postoperative Ileus

Patients undergoing major abdominal surgery are at highest risk for developing Postoperative Ileus (POI), occurring in nearly all cases. Signs and symptoms of POI may include abdominal distention and bloating, persistent abdominal pain; nausea and/or vomiting; variable reduction of bowel sounds; delayed passage of or inability to pass flatus or stool; and inability to tolerate a solid diet. This study will test the ability of alvimopan 12 mg given 30 to 90 minutes before the scheduled start of surgery to hasten the recovery of GI function in patients having partial small or large bowel resections.

Postoperative ileus (POI) can be thought of as temporary slowing down or stopping of bowel function and a slowing down of movement of contents of the intestines. Patients undergoing major abdominal surgery are at highest risk for developing POI, occurring in nearly all cases. Signs and symptoms of POI may include abdominal distention and bloating, persistent abdominal pain; nausea and/or vomiting; variable reduction of bowel sounds; delayed passage of or inability to pass flatus or stool; and inability to tolerate a solid diet. This study will test the ability of alvimopan 12 mg given 30 to 90 minutes before the scheduled start of surgery to hasten the recovery of GI function in patients having partial small or large bowel resections.

Eligibility Criteria:
Inclusion Criteria:

* Subject is scheduled for a partial small/large bowel resection with primary anastomosis; all procedures must be performed completely by open laparotomy.
* Subject is scheduled to receive primary postoperative pain management with intravenous (i.v.) patient-controlled analgesia (PCA) opioids.

Exclusion Criteria:

* Subject is scheduled for a total colectomy, colostomy, ileostomy, any laparoscopic or laparoscopically-assisted procedure, or subject has a history of gastrectomy, total colectomy, short bowel syndrome, or multiple previous abdominal surgeries performed by open laparotomy.
* Subject has complete bowel obstruction.
* Subject is currently taking opioid analgesics or has taken more than three doses of opioids (oral or parenteral) within the previous 7 days prior to the day of surgery.
EFFECT OF SCAR RELEASE TECHNIQUES ON CHRONIC SCAR PAIN AND MOBILITY POST CESAREAN SECTION

Purpose of the study:

The aim of this study is to determine the effect of scar release techniques on chronic scar pain and mobility post cesarean section.

Hypothesis:

* H0: There is no effect of scar release techniques on chronic scar pain and mobility post cesarean section.
* HA: There is effect of scar release techniques on chronic scar pain and mobility post cesarean section.

A vicious impediment on quality of life including psychological and functional disability, and interference with baby care and bonding may occur among women who experience chronic post-caesarean section pain (CPCSP) .

Structural alterations of the skin and subcutaneous tissues with scarring result in reduced mobility and viscoelasticity that could cause compression of the sensory receptors and nerve ﬁbers and disrupt their signaling. The viscoelastic properties could potentially be modiﬁed when the skin and scars are stressed and/or strained by manual therapies and this can affect the sensitivity threshold of the mechanosensitive and nociceptive receptors.

There are limited studies about the effect of various scar release techniques on chronic post cesarean section scar pain and mobility and their impact on quality of life on the affected women . So, this study will be helpful and of valuable benefits for medical services organizations and increase body of knowledge of physical therapists in scientific field.

This study will be conducted on forty women suffering from chronic post cesarean section scar pain and restricted scar mobility , they will be referred from department of Obestetrics and Gynaecology in Elmansoura International Hospital, Egypt.

Eligibility Criteria:
Inclusion Criteria:

* Women with a well healed, old , transverse cesarean section scar (more than 6 months resulted in chronic scar pain).
* Pain can be intermittent or constant at rest or with activity, and it is reported to be at least at a level of about 3/ 10 on visual analogue scale at recording sites will be marked on the C-section scar at 2.5 cm intervals .
* Women identified that the pain is either located in the cesarean section scar or caused by palpation of scar and it presents since the time of surgery not prior to the cesarean section.
* Their ages will range from 25-35 years old.
* Their BMI will be 18.5-29.9 kg/ m².
* Voluntary acceptance to participate in the study.

Exclusion Criteria:

* Women will be excluded if they have :
* Acute and subacute cesarean section.
* Delayed wound healing.
* History of abdominal or pelvic cancer.
* Active pelvic or abdominal infection.
* Skin irritation/inflammation at the site of scar.
* Currently pregnant women.
Study of LM-305 in Patients With Relapsed or Refractory Multiple Myeloma (RRMM) and Other Plasma Cell Diseases

A Phase I/II Study of LM-305 in Patients with Relapsed or Refractory Multiple Myeloma (RRMM)

A Phase I/II, Open-Label, Multiple Centre Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of LM-305 in Patients with Relapsed or Refractory Multiple Myeloma (RRMM)

Eligibility Criteria:
Inclusion Criteria:

Subjects will be enrolled into the study only if they meet all of the following inclusion criteria:

1. Subjects who are fully informed of the purpose, nature, method and possible adverse reactions of the study, and are willing to participate in the study and sign the informed consent form (ICF) prior to any procedure.
2. Aged ≥18 years old when sign the ICF, male or female.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1。
4. Life expectancy ≥ 6 months.
5. Subjects must show appropriate organ and marrow function in laboratory examinations

Exclusion Criteria:

Subjects will be excluded from the study, if they meet any of the following criteria:

1. A history of other malignant tumors than multiple myeloma within 3 years prior to first dosing
2. Subjects who have severe cardiovascular disease。
3. Use of any live attenuated vaccines within 28 da ys prior to 1st dosing of IMP.
4. Child-bearing potential female who have positive results in pregnancy test or are lactating.
5. Subject who is judged as not eligible to participate in this study by the investigator.
Performance of an Investigational Blood Glucose Monitoring System

The purpose of this study was to demonstrate that untrained subjects who have diabetes can operate the Investigational Blood Glucose Monitoring System (BGMS) and obtain valid glucose results.


Eligibility Criteria:
* Inclusion Criteria:

  1. Males and females, 18 years of age or older.
  2. People with type 1 or type 2 diabetes.
  3. Able to speak, read and understand English.
  4. Willing to complete all study procedures.
* Exclusion Criteria:

  1. Hemophilia or any other bleeding disorder.
  2. Pregnancy.
  3. Physical, visual or neurological impairments that would make the person unable to perform testing with the BGM.
  4. Previously participated in a blood glucose monitoring study using the Ninja 3 Plus BGMS.
  5. Working for a medical laboratory, hospital or other clinical setting that involves training on or clinical use of blood glucose meters.
  6. Working for a competitive medical device company, or having an immediate family member who works for such a company.
  7. A condition, which in the opinion of the investigator or designee, would put the person or study conduct at risk.
Insulin Pump Therapy in Adolescents With Newly Diagnosed Type 1 Diabetes (T1D)

Within 4 weeks after diagnosis of type 1 diabetes, 10 subjects (pubertal males, 12-17 years old) will be randomized to either receive multiple daily injection (MDI) using Lantus insulin, or continuous subcutaneous insulin infusion (CSII; pump therapy). The study evaluates how these modes of therapy affect insulin sensitivity (measured by the euglycemic-hyperinsulinemic clamp studies and adiponectin concentration changes) and beta cell function (measured by mixed meal tolerance testing).

Within 4 weeks after diagnosis of type 1 diabetes, 10 subjects (pubertal males, 12-17 years old) will be randomized to either receive multiple daily injection (MDI) using Lantus insulin, or continuous subcutaneous insulin infusion (CSII; pump therapy). The proposed protocol compares the changes in diabetes control between pump therapy and MDI treatment groups. More importantly, however, the study evaluates how these modes of therapy may affect the honeymoon period and glycemic control, specifically focusing on changes in insulin sensitivity (measured by the euglycemic-hyperinsulinemic clamp studies and adiponectin concentration changes) and beta cell function (measured by mixed meal tolerance testing). Demonstrating that pump therapy at the time of diagnosis of type 1 diabetes prolongs the honeymoon phase by improving insulin sensitivity and beta cell function may have important therapeutic implications that could influence the standard of care in pediatric diabetes.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patient between the age of 12 and 17 years inclusive at time of entry into study (i.e., after their 12th but before their 18th birthday)
* Type 1 diabetes mellitus for no more than 10 days
* pubertal (Tanner stage 2 or above)
* The patient and parents or guardians should be able to do simple math calculations (necessary for pump management)
* Parent or legal guardian must give signed informed consent

Exclusion Criteria:

* No other chronic medical conditions (well-controlled thyroid disease is OK, and mild asthma is OK if the patient is not on chronic inhaled or oral daily corticosteroids)
* Exceptional psychological stress, more than expected for circumstances of having the new diagnosis of diabetes
* Inability or unwillingness to comply with requirements of the protocol
Safety and Efficacy Study of Rituximab in Renal Transplantation

Current strategies for the medical management of transplant patients are largely focused on the prevention and treatment of T-lymphocyte mediated processes. However there is an increasing evidence to suggest that B-lymphocytes have a role in the otherwise classic T-cell mediated rejection of transplants by there ability to act as antigen presenting cells and T-cell activators. Thus there is a significant medical need for effective therapies targeting B cells of transplant patients.One such potential therapy would be to use rituximab, a monoclonal antibody against B-cells in all renal transplant patients. In the present study the efficacy and safety of prophylactic rituximab is studied.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years or above
* Recipients of first or second renal transplants
* Recipients of kidneys from living or cadaveric donors
* Single organ recipients (kidney only)
* Patients providing written informed consent
* Patients cooperative and able to complete all the assessment procedures

Exclusion Criteria:

* Patients receiving other immunosuppressive therapy within the preceding 28 days
* Recipients of HLA-identical sibling kidneys
* Patients with flow-PRA \>50% within 6 months prior to enrolment
* Recent history of malignancy
* Active infection
* Pregnant or lactating females
* Women of childbearing potential not willing to use reliable form of contraception
Efficacy of Audio Recorded Guided Imagery vs Deep Breathing Exercises on Functional Gastrointestinal Pain Disorders

The purpose of this study is to:

1. Determine if audio recorded guided imagery vs deep breathing exercises delivered via a digital media player improves abdominal pain symptoms in children with functional gastrointestinal pain disorders managed in the primary care setting.
2. Determine if audio recorded guided imagery and deep breathing exercises delivered via a digital media player improves psychosocial distress in children affected by functional gastrointestinal pain disorders managed in the primary care setting.

The possibility of treating functional gastrointestinal pain disorders using remotely delivered psychosocial therapies has the potential to treat many children affected by functional gastrointestinal pain disorders in a cost-effective manner. This study will provide insight into how well these patients in the primary care could benefit from such interventions.

Children managed in primary care with a functional gastrointestinal pain disorder will be recruited and studied for this trial. After participants are deemed eligible, they will complete multiple questionnaires and then be randomly assigned (like a flip of a coin) to either guided imagery or deep breathing exercises delivered via a digital media player. Participants will be instructed to listen to the tracks at least 5 days per week for an 8 week intervention period.

At week 3 of the intervention period, the participant will complete another 2 week pain and stool diary.

At week 7 of the intervention period, the participant will complete another 2 week pain and stool dairy. After this diary is completed, the participant will again complete multiple questionnaires for their final visit.

Eligibility Criteria:
Inclusion Criteria:

1. Children who meet criteria for a functional gastrointestinal pain disorder.
2. Children who manage their abdominal pain in the primary care setting.

Exclusion Criteria:

1. Children who have other comorbidities that are associated with chronic abdominal pain including abdominal surgery and other medical diagnoses that can cause chronic abdominal pain.
2. Children with an intellectual disability which would hamper their ability to communicate with study staff about their pain and complete study questionnaires.
3. Children who have presented to a gastroenterologist for abdominal pain management
4. Children who have previously used deep breathing exercises or guided imagery to manage their abdominal pain.
Ciclosporin A and Acute Myocardial Infarction

Beyond its immunosuppressive properties, ciclosporine A (CsA) can also inhibit the opening of a mitochondrial mega-channel called the permeability transition pore (mPTP). Opening of the mPTP plays a key role in cardiomyocyte death during reperfusion following a prolonged ischemic insult. Ciclosporin A has been shown to reduce infarct size when administered at reperfusion in experimental models. The objective of the present study is to determine whether administration of CsA at reperfusion in patients with ongoing acute myocardial infarction treated by coronary angioplasty might reduce infarct size.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients, aged more than 18, with suspected first acute myocardial infarction
* Within 12 hours of the onset of chest pain
* With a need for emergency revascularization by angioplasty. Patients must display a fully occluded (TIMI zero flow) culprit coronary artery, absence of visible collaterals and exhibit TIMI flow \>2 after direct stenting by angioplasty.

Exclusion Criteria:

* Hypersensibility to ciclosporine A
* Cardiac arrest or cardiogenic shock
* Immunosuppressive disease (\< 6 months): cancers, lymphomas, positive serology for HIV, hepatitis, etc.
* Known renal failure or serum creatinine \> 120 µmole/l at admission
* Liver failure
* Uncontrolled hypertension
* Current pregnancy or women without contraception
Intraoperative Ultrasound in Crohn's Disease

To study the role of intraoperative ultrasound of small bowel as a possible tool that can reduce the rate of histologically involved resection margins from Crohn's Disease.

Patients with indication for resective surgery for Crohn's Disease will be enrolled and undergo to the planned surgery.

During surgery the site where to conduct the bowel resection will be decided according to the current indications in the literature and according to good clinical practice (absence of macroscopical signs of disease).

Before conducting the surgical resection, will be performed intraoperative ultrasonography of the small bowel at the intestinal segment chosen as the site of the resection.

Ultrasound features will be evaluated to determine whether or not there are any ultrasonographic signs ascribable to Crohn's Disease.

Once the above ultrasound has been completed (estimated time approximately 5-10 minutes), the predetermined resection will be conduct and the surgical piece will be sent for final histological examination as usual.

The outcome of intraoperative ultrasound will be schematized as positive or negative based on the presence or absence of specific ultrasound signs of intestinal inflammation attributable to Crohn's Disease.

The data will be collected and subsequently analyzed in order to compare the ultrasound findings acquired on the resection margins with the outcome of the histological examination conducted on the same site.

Patients will then enter a regular gastroenterological/surgical follow-up and undergo colonoscopy at 12 months after surgery as usual.

Data on clinical, surgical or endoscopic recurrence in the follow-up period will be collected and analyzed to compare the recurrence rate in the group of patients with intraoperative ultrasonographic features with the group without intraoperative ultrasonographic features on the resection margin.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 12 years or older.
* Confirmed diagnosis of Crohn's disease
* Indication for intestinal resection surgery for Crohn's Disease (first surgery or surgery for postoperative recurrence).

Exclusion Criteria:

* Patients who did not express their consent to participate in the study by signing the appropriate informed consent
* Patients younger than 12 years of age
* Patients with an indication for non-resective surgery for Crohn's Disease (e.g., ileostomy closure).