cyrilzakka/clinical-trials huggingface dataset:
Stem Cell Therapy for Type 1 Diabetes Mellitus

The purpose of this study is to evaluate the feasibility, efficacy and safety of transplantation therapy using bone marrow mononuclear cells and umbilical cord mesenchymal stem cells for patients with type 1 diabetes mellitus

To evaluate the feasibility, safety and efficacy of transplantation using autologous bone marrow mononuclear cells and umbilical cord mesenchymal stem cells in patients with type 1 diabetes mellitus.

Eligibility Criteria:
Inclusion Criteria:

1. Free will taking part in the study and ability to provide written informed consent.
2. Confirmed diagnosis of type I diabetes for at least 2 years
3. Insulin-dependent.
4. Age 18-50 years, Male/Female.
5. FBG≥7.0 mmol/L, and HbAc1≥7％.
6. Not pregnant or nursing.
7. Negative pregnancy test.
8. Fertile patients will use effective contraception.

Exclusion Criteria:

1. Presence of acute diabetic complications in the acute stage as recent myocardial infarction, recent cerebral vascular accident (CVA) or acute renal failure.
2. Severe concurrent medical condition (e.g. lung disease, or hematopoietic dysfunction, or liver dysfunction).
3. Active infection requiring treatment.
4. Known immunosuppressive disease, e.g. HIV infection, or hepatitis B or C infection.
A Clinical Trial of an Acetal Resin Crown for Restoration of Primary Molars

Preformed stainless steel crowns have been used in Pediatric Dentistry to restore badly broken down primary teeth since 1950. They are generally considered more expedient to place than large multi-surface amalgam or composite restorations and have a longer life. They have been used successfully in clinical practice for many years and have presented little in the way of adverse events. The major drawback is the poor esthetics along with lingering concerns over potential health hazards associated with the nickel content. Several attempts have been made to improve upon the esthetics of stainless steel crowns such as veneering the buccal and occlusal surfaces and substituting composite resin for the entire crown, but to date none of these approaches have been very successful.

Acetal resin has been used in a number of applications in medicine and dentistry, and recently has met with early success when tested as a substitute for stainless steel crowns. It has a number of excellent physical and mechanical properties including a low coefficient of friction, good wear resistance, high fatigue resistance, good impact strength and resistance to creep.

The purpose of this trial is to compare the clinical performance of preformed acetal resin crowns and preformed stainless steel crowns.

2.0 OBJECTIVES

The objective of this study is to compare the clinical performance of acetal resin crowns with preformed stainless steel crowns when used to restore primary molar teeth.

STUDY POPULATION

A minimum of 25 subjects contributing a minimum of 40 acetal crowns ( on primary molar teeth will be recruited from the patient pool of the pediatric dentistry clinic at Barzilai Medical Center, Ashkelon and enrolled into the study. A maximum of four crowns will be placed in any subject. It is estimated that it will take approximately 14 weeks to place all crowns and complete the baseline examination.

Eligibility Criteria:
Inclusion Criteria:

* Patients of record at the pediatric dentistry clinic at Barzilai Medical Center, Ashkelon
* Ages 3-8 (inclusive)
* In need of at least one Stainless Steel Crown on either a first or second primary molar

Exclusion Criteria:

* Medically compromising condition
* Informed consent not given
* Teeth with proximal space closures of sufficient magnitude to preclude placement of a test crown
Multiparametric Characterization of Orbital Tumors by MRI

Prospective study on patients with orbital tumors of unknown origin. Aim of the study is to differentiate benign from malignant tumors upon MR imaging. Magnetic resonance imaging of the orbit will be performed including standard morphological sequences and advanced sequence techniques. These advanced sequence techniques may allow to differentiate benign from malignant tumors based on their cellularity and vascularity (diffusion and perfusion imaging). These MRI data will be analysed and the level of diffusion and perfusion will be measured and compared to the histological findings. Cut-off values of diffusion and perfusion will be calculated that allow to separate benign from malignant tumors.


Eligibility Criteria:
Inclusion Criteria:

* non-diagnosed orbital tumors

Exclusion Criteria:

* any metal implants, non-MRI compatible
* age below 18
* pregnancy
* recent surgery
* recent severe medical diseases
PDE-4 Inhibitor Roflumilast and Polycystic Ovary Syndrome

The purpose of this study was to determine whether combined treatment with phosphodiesterase-4 (PDE-4) inhibitor roflumilast and metformin is more effective than metformin as monotherapy in the treatment of obese women with polycystic ovary syndrome (PCOS) who had been previously poor responders regarding weight reduction on metformin monotherapy. The investigators anticipated greater changes in body weight in patients on combined treatment than in those on monotherapy with metformin.


Eligibility Criteria:
Inclusion Criteria:

* 18 years old to menopause
* polycystic ovary syndrome (NICHD criteria)
* BMI of 30 kg/m² or higher

Exclusion Criteria:

* depression
* type 1 or type 2 diabetes mellitus
* history of carcinoma
* Cushing's syndrome or congenital (non-classic) adrenal hyperplasia
* significant cardiovascular, kidney or hepatic disease
* the use of medications other than metformin known or suspected to affect reproductive or metabolic functions
* the use of statins, within 90 days prior to study entry
The Effect of Prucalopride (Resolor®) on Gastric Motor Function and Gastric Sensitivity

Functional Dyspepsia-Postprandial Distress Syndrome (FD-PDS), is characterized by meal-related symptoms such as early satiation and postprandial fullness. Disturbances of gastric motor function have been implicated the pathogenesis of PDS symptoms, and hence, motility modifying agents are considered for the treatment of PDS. Prucalopride (Resolor®), a highly selective 5-TH4 receptor agonist which stimulates gastrointestinal motility throughout the GI tract, is currently approved for the treatment of chronic constipation. The objective of this study was to evaluate the effect of prucalopride on gastric sensorimotor function in healthy volunteers (HV). Methods A total of 17 HV (59% females, mean age 29.4±2.7 years) underwent a barostat and intragastric pressure (IGP) measurements after treatment with placebo or prucalopride (2 mg) in a single blinded cross-over fashion. Isobaric distentions with stepwise increments of 2 mm Hg starting from minimal distending pressure (MDP) and scoring of intensities of gastric sensations (0-6: pain) were used to determine gastric compliance and sensitivity. Gastric accommodation (GA) was quantified as the difference (delta) in intra-balloon volume 30 min before and 60 min after ingestion of 200 ml of a nutrient drink (ND) (1.5 kcal mL(-1)). GA measured by IGP was quantified as the drop of IGP from baseline during the intragastric infusion of ND until maximal satiation. During all tests, epigastric symptoms were scored every 5 minutes.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers, male and females, between 18-60 years old

Exclusion Criteria:

Subjects that:

* They are older than 60 years old.
* Have severely decreased kidney function.
* Have severely decreased liver function.
* Have severe heart disease, for example a history of irregular heartbeats, angina or heart attack.
* Have severe lung disease.
* Have severe psychiatric illness or neurological illness.
* Have any gastrointestinal disease
* Women that are pregnant or breastfeeding.
* Have a rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption (Resolor tablets contain lactose).
Combined Effects of Transcranial Direct Current Stimulation on Postural Control in Elderly

The current study aims to determine the effects of combination stimulation (M1 Cortex+ Cerebellum) along with balance training (X-box with Kinect) on postural control in elderly population and to compare the combined stimulation (M1+CbS) with individual motor cortex, cerebellar or sham stimulation.

The current study has been designed to investigate the potential effects of short term transcranial direct current stimulation on motor cortex and cerebellum both simultaneously and to document any additional benefits over each individual stimulations (M1 cortex stimulation, cerebellar stimulation or sham stimulation). Patients will be receiving the transcranial direct current stimulation combined with non-immersive virtual reality using Xbox 360 with Kinect in each group.

Eligibility Criteria:
Inclusion Criteria:

* Both genders
* Healthy elderly patients
* Age group of ≥ 60 years
* Fluent in reading and speaking Urdu language

Exclusion Criteria:

* Patients who have any congenital/Acquired walking or standing difficulty due to certain circumstances won't be included in the healthy adults group.
* Patients with Osteo-Arthritis (OA)
* Patients with cerebellar issues or issues such as vertigo with standing and walking etc.
* Individuals who had significant dysarthria or aphasia that might impair understanding of speech or verbal instruction
* Cognitive/communication impairment
Mortality of Patients Undergoing Fracture of the Upper Extremity u Femur at the University Hospital of Amiens

Fractures of the upper femur (EFSF) represent a major public health problem in the elderly. Approximately 1.6 million patients are victims each year of an EFSF and this number is increasing as a result of the aging of the population.

In a recent Amiens retrospective study the mortality was estimated to be 22.5% at 1 year of the fracture. In surviving patients, the impact on loss of autonomy and degradation of quality of life is considerable.

The reduction of the incidence of post-operative complications includes the identification of risk factors.

No prospective study in Amiens has investigated the mortality and the study of the variables involved in the prognosis and long-term mortality of these patients.


Eligibility Criteria:
Inclusion Criteria:

* All the patients operated from a fracture of traumatic origin of the ESF to the emergency block at the CHU of Amiens
* Patients transferred to the CHU after being cared for in another structure will be included.
* If a patient successively presents a fracture of each upper extremity of the femur outside of a surgical resumption, two inclusions will be realized

Exclusion Criteria:

* Do not include non-traumatic fractures of the upper end of the femur (pathological fractures: cancer, for example)
* Fractures of the upper end of the femur associated with polytrauma will not be included.
Simplification of Oral Sodium Loading Test in the Diagnosis of Primary Aldosteronism: 2-day Replacing 3-day Method

To compare the consistency of 24-hour urinary aldosterone in the diagnosis of primary aldosteronism by oral sodium loading test between the second day method and the third day method

This is an exploratory and prospective study of 17 healthy controls and 15 patients with primary aldosteronism, in which each participant will receive a high-sodium diet for 3 days to conduct a confirmatory test for primary aldosteronism. The consistency between the 2-day and 3-day oral sodium loading test for the diagnosis of primary aldosteronism is compared by measuring the 24-hour urinary aldosterone levels of the participants on the second and third days of the high-sodium diet. The study aims to explore whether the 24-hour urinary aldosterone level on the second day can replace the 24-hour urinary aldosterone level on the third day for the diagnosis of primary aldosteronism.

Eligibility Criteria:
PA patients:

Inclusion criteria:

* Patients with hypertension and hypokalemia who have been diagnosed with primary aldosteronism following the latest version international guidelines for primary aldosteronism.
* Age: 20-70 years old, male and female;
* BMI: 18.5-23.9 kg/m2;

Exclusion criteria:

* Other causes of endocrine hypertension including pheochromocytoma, Cushing syndrome, etc.
* Renal artery stenosis and low potassium due to other factors, such as renal tubular acidosis, Bartter syndrome, Gitelman syndrome, etc.
* History of hyperthyroidism, hepatic and renal insufficiency, malignant tumors, metabolic diseases, cardiovascular diseases, and mental diseases,menstrual disorders Healthy volunteers

Inclusion criteria:

* Age: 20-70 years old, male and female;
* BMI: 18.5-23.9 kg/m2;
* Blood pressure: 90-120/60-80 mmHg on three consecutive office blood pressure readings;
* Female must have regular menstrual cycle (blood and urine samples should be taken during the non-menstrual period);
* Regular dietary habits;
* No medications taken within the past 1 month.

Exclusion criteria:

* History of hypokalemia.
* History of liver and kidney dysfunction, malignant tumors, metabolic disorders, cardiovascular diseases, and psychiatric disorders, etc.
* Menstrual irregularities and taking contraceptive pills.
* History of hypertension
* Have taken any drugs including anti-inflammatory drugs, potassium diuretics, or special health products in the 4 weeks prior to the examination,
Assessment of Bifocal and Prismatic Bifocal Spectacles for Myopia Control in Children

1. To determine if the effect of near-addition lenses (bifocals) is more prominent for children with high myopia progression.
2. To study how different subject characteristics such as age, gender, baseline degree of myopia, baseline near phoria and baseline lag of accommodation affect the efficacy of bifocal lens wear in myopic children.
3. To investigate the effect of incorporating near base-in prisms along with the near-addition lenses (prismatic bifocals) on myopia progression in myopic children.


Eligibility Criteria:
Inclusion Criteria:

* Age: 8 to 13 years
* Myopia: -1.00 to -5.00 D
* Myopia progression: at least 0.50 D/yr
* Astigmatism and anisometropia: not more than 1.50 D
* Distance monocular visual acuity: 6/6 or better
* Near monocular visual acuity: 0.4 M or better
* Stereoacuity: not more than 40 sec of arc at 40 cm

Exclusion Criteria:

* Strabismus
* Ocular diseases
Study to Evaluate Nosocomial Transmission of Influenza

The purpose of this study is to investigate whether influenza can be reliably transmitted from children to susceptible contacts in a health care setting. The goal is to develop a transmission that can then be used to assess interventions to prevent transmission

Research objectives:

To develop a model to investigate the frequency of influenza transmission from an infected child to a susceptible health care worker

Research Hypotheses:

Influenza viruses can be transmitted from infected children to exposed health care workers

CHildren with influenza infection presenting to ED will be identified by RAT. Healthy healthcare worker subjects will expose themselves and perform specific activities with the child.

subjects will be followed by diary card, clinical symptom scores and virology swabs to assess frequency of transmission

Eligibility Criteria:
Inclusion criteria:

* Infected Children

  * Age \< 16 years
  * Parents or legal guardians willing to give informed written consent
  * Presenting with a febrile illness confirmed as influenza by near patient rapid antigen testing
* Healthy volunteers

  * Willing to give informed written consent

Exclusion criteria

* Children

  * No parents or legal guardians able to give informed consent
* Healthy volunteers

  * known allergy to oseltamivir or zanamivir
  * presence of underlying condition or concomitant therapy requiring dose alteration of oseltamivir (severe renal or hepatic failure; methotrexate and probenecid)
  * underlying immunosuppressive disorder
  * known galactose intolerance
  * underlying chronic medical condition known to increase risk of influenza-related complications (including asthma, chronic pulmonary airways disease, chronic cardiovascular disease, diabetes mellitus, chronic neurological disorder)
  * inability or contraindication to collection of nasal swabs
  * previous influenza vaccination within 2 years
  * current smoker
  * pregnancy
Study of ME-609 and Acyclovir for Treatment of Herpes Simplex Labialis in Immunocompromised Patients

The purpose of this study is to evaluate the episode duration of a herpes labialis recurrence in immunocompromised patients treated with ME-609 or Acyclovir.

The objective of this study was to evaluate the episode duration of a herpes labialis recurrence, following a 5-day treatment with 5-time daily topical administration of ME-609 or acyclovir cream, in immunocompromised adults, 18 years and older.

This interim report summarizes the results for short-term observations, i.e., during the initial study recurrence. A final study report will be prepared when the long-term follow-up is completed.

Eligibility Criteria:
Inclusion Criteria:

* History of recurrent herpes labialis with at least two recurrences during the twelve months prior to the study.
* Stable HIV infection
* CD4+ T-cell count 100 to 500/mm3

Exclusion Criteria:

* Systemic treatment with other antiviral agent or corticosteroids within two weeks prior to and during the treatment period, except for antiretroviral treatment in HIV subjects
* Topical treatment with other antiviral agent or corticosteroids within in or around the oral area within two weeks prior to study drug administration
* Significant skin condition that occur in the area typically affected by herpes recurrences
* Nursing or pregnancy
* Concurrent cancer therapy
A Trial of Adjuvant Transarterial Chemoembolization (TACE) for Preventing Tumor Recurrence After Liver Resection

The aim of this study is to analyze the therapeutic effect of adjuvant TACE after resection.Patients receiving curative resection (R0) were randomized to postoperative TACE group and no TACE group. The time to recurrence ,the overall survival as well as the incidence of complications after therapy was observed to confirm the role of adjuvant TACE.

Although resection of hepatocellular carcinoma is potentially curative, local recurrence is common with the recurrence rate higher than 50% during 5 years. So to reduce the recurrence rate of HCC, some interventions had been tried in clinic, including transarterial chemoembolization (TACE), immunotherapy, and interferon treatment etc. But few of these adjuvant therapies had been proved effective and their long term efficacy and clinical application remained further explored.

TACE had been prove to be effective in patients with advanced stage of HCC in randomized controlled trials and meta-analysis, but the role of adjuvant TACE after liver resection is controversial. The results getting from different randomized control trials varied significantly because of the bias of patient selection, different study design，the small size of sample, different drug used in chemotherapy and lack of proper stratification...,so a big sample size, well patients selected and well designed randomized controlled trial is needed to further confirm the role of the postoperative TACE.

Patients with HCC who received curative liver resection (R0) were randomly assigned 1:1 by the doctors to receive no adjuvant TACE(control group) or TACE(treatment group). All patients in the treatment group received adjuvant TACE 45 days after liver resection. The outcomes of patients were evaluated during the 3-years follow up.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients \> 18 years and \<=70 years of age.
2. Patients with HCC who received curative liver resection (R0).
3. Criteria of liver function: Child A-B level, serum bilirubin ≤ 1.5 times the upper limit of normal value,alanine aminotransferase and aspartate aminotransferase ≤ 2 times the upper limit of normal value.
4. No dysfunction in major organs; Blood routine, kidney function, cardiac function and lung function are basically normal. Hb ≥90g/L,WBC ≥3.000 cells/mm³,platelets ≥80.000 cells/mm³ .
5. Karnofsky Performance Score performance over 60 .
6. Patients who can understand this trial and have signed information consent

Exclusion Criteria:

1. Patients with apparent cardiac, pulmonary, cerebronic and renal dysfunction,which may affect the treatment of liver cancer.
2. Patients with other diseases which may affect the treatment mentioned here.
3. Patients with medical history of other malignant tumors.
4. Subjects participating in other clinical trials.
5. Extrahepatic metastasis, portal vein or other major vascular involvement. liver function:Child C.
6. Patients would not sign the consent to the trial.
Study Using High-Dose Single Fraction Image-Guided Radiotherapy for Metastatic Lesions to Soft Tissue Masses, Lymph Node, or Bone

The purpose of this research study is to find out what IG-IMRT radiation dose works best for treatment of disease in bone or soft tissues. This protocol will study what dose level may work most effectively. The first part of study will treat 10 patients with 22 Gray. Gray (Gy) is the unit that is used to describe the dose of radiation that is being given to a person with cancer. After we confirm that 22 Gy is a safe and sufficient amount of radiation, we will then treat another group of patients with 24 Gy and so on until we reach 28 Gy. Each dose level starting with 24 Gy will enroll at least 20 patients per treatment site (bone, bowel and/or spine). Patients will be enrolled in each treatment category until 20 patients in each strata reach an evaluable time point of 3 months post-RT. When we understand what dose works best and has the least amount of bad effects, the study will then look to see how well the patients do after the radiation therapy. This study is trying to see how your doctor can best treat the cancer that has spread to the other parts of your body.


Eligibility Criteria:
Inclusion Criteria:

* Biopsy-proven cancer verified at MSKCC
* Imaging evidence of lymph node metastases, bone metastases or soft tissue disease
* Age \> or = to 18 years
* KPS \> or = to 80
* Epidural disease is acceptable as long as the dose to the spinal cord ≤ 14 Gy
* Able to tolerate immobilization cradle positioning

Exclusion Criteria:

* Target lesion not visible on conventional CT scan
* Unable to be administered intravenous CT contrast safely
* Prior radiation to the planned target region. A second metastatic lesion would not be eligible if the area received or will receive any dose (5% or greater isodose line)from a prior or planned single fraction treatment
* Patients receiving concurrent chemotherapy (within 1 week of RT)
* Normal tissue directly overlying target precluding ability to limit the bowel, bladder, rectum or other tissue to 15-16 Gy dose constraints
* Weight-bearing bones with significant cortical destruction from tumor. In these cases, patients will be referred for orthopedic consultation for rod stabilization procedures.
* Subjects with more than 4 metastases to bone
* Any metastatic lesion larger than 8 cm in its greatest diameter
Vivatmo proTM EU-study: FeNO Monitoring in Asthmatic Patients Responding to ICS Treatment

This is a multi-center study to evaluate fractional exhaled nitric oxide (FeNO) measured with the Vivatmo pro in adult and pediatric subjects.

Subjects will be screened, enrolled and tested at Study Visit #1 and then prescribed inhaled corticosteroid (ICS) treatment as per routine clinical care. Subjects will return for Study Visit #2 in two weeks and repeat fractional exhaled nitric oxide (FeNO) measured with the Vivatmo pro,

Eligibility Criteria:
Inclusion Criteria:

1. Subject is 7 to 80 years of age.
2. Has asthma
3. Has been identified as a candidate for inhaled corticosteroid (ICS) treatment
4. Is willing and able to perform Vivatmo pro™ testing

Exclusion Criteria:

1. Subject has used corticosteroids prior to enrollment.
2. Subject has other current serious medical conditions
3. Subject has not been clinically stable for at least 2 weeks prior to the study
4. Subject is unwilling or unable to perform Vivatmo pro testing