cyrilzakka/clinical-trials huggingface dataset:
Whole Grain, Gluten-containing Cereal and PROBIOtics to Evaluate Digestive TOLERAance and Immuno-inflammatory Response

This study will assess the development of gastrointestinal health in terms of digestive tolerability and immune-inflammatory response at the intestinal level comparing a conventional gluten-free cereal with a new cereal with prebiotics, probiotics and a very moderate amount of gluten. These are products adapted to infant feeding since 4 Months.

In 2008 the ESPGHAN recommended not to give gluten cereals before 4 months but not after 7 months. Although the introduction of gluten in this window was linked to a posible preventive effect on celiac disease, the truth is that it has not been demonstrated. In any case, high exposures to gluten since the 4 months have been associated with a higher incidence of celiac disease and current recommendations propose moderate and progressive exposure to gluten between 4 and 6 months old.

Eligibility Criteria:
Inclusion Criteria:

* Healthy term infants (\>37 weeks) vaginal delivery
* Adequate birth weight for gestational age (10-90 percentile)
* Infants with normal growth curve (10-90 percentile)
* Infants who were breastfeeding for at least 4 weeks, and at least half of the takes have been by breastfeeding.
* Infants aged 4 months (+/- 1 week) at the time of study inclusion no longer following breastfeeding, or mixed breastfeeding and if they are breast-feeding, no more than one shot a day.
* Availability to continue throughout the study period.
* Signature of informed consent by partents/guardians.

Exclusion Criteria:

* Infants who were born by cesarean section
* Infants born from preconception obese mothers
* Infants born from diabetic mothers or mothers with gestational diabetes
* Infants with a family history of celiac disease (parents or siblings)
* Infants who have had or have some type of allergic manifestation or allergic pathology
* Infants who have needed antibiotic treatment or have received some type of probiotic (the week before inclusion)
* Infants with malformations, diseases or conditions and physical disabilities that cause changes in growth and/or nutritional status
* Infants diagnosed with any immune system-related disease (primary immunodeficiency)
* Infants with a known allergy and/or intolerance to cow's milk protein
* Parents' inability to follow study (at the discretion of the researcher)
Singapore Tympanostomy Tube Delivery System Study

The objective of the study is to evaluate the safety and efficacy of the Acclarent Tympanostomy Tube Delivery System (TTDS) in the placement of tympanostomy tubes (TTs) in patients indicated for such treatment for chronic otitis media with effusion (OME) or recurrent acute otitis media (AOM).


Eligibility Criteria:
Inclusion Criteria:

1. \>= 1 year of age
2. Diagnosed with either Chronic Otitis Media with Effusion or recurrent Acute Otitis Media and scheduled to undergo bilateral or unilateral tympanostomy tube insertion.
3. Either male or female -

Exclusion Criteria:

1. History of sensitivity or reaction to anaesthesia
2. Markedly atrophic, retracted, atelectatic or perforated tympanic membrane.
3. Otitis externa
4. Active acute otitis media
5. Thickened Tympanic Membrane
6. Thick mucoid effusion (also known as "glue ear")
7. Otitis media pathology requiring T-tubes -
Early Biomarkers in Circulating α 4β7 + T Cells to Predict Response to Vedolizumab in Inflamatory Bowel Disease Patients.

Background: Infiltration of GI by T lymphocytes is a pathogenic mechanism both in ulcerative colitis (UC) and in Crohn's disease (CD). Vedolizumab (VDZ) is a humanized monoclonal antibody binding with high affinity to α4β7 integrin blocking α4β7+-MAdCAM-1 interaction, hence blocking a key step in GI lymphocytes T infiltration. VDZ has demonstrated a therapeutic effect in UC and CD. Investigators still lack of adequate biomarkers to predict clinical response to biological treatments, specially avoiding invasive procedures.

Objective: Study whether circulating CD4+ and CD8+ α4β7+ memory T lymphocytes and some of their surface markers might be molecular markers of response to VDZ treatment in patients with UC and CD.

Methods: Prospective (pilot) study including 24 adult IBD patients (12 UC patients and 12 CD patients (patients with fistulizing perianal disease will be excluded) with active disease and prior failure to anti-TNFα treatments starting treatment with VDZ. They will received VDZ in standard induction (300mg intravenously, 0-2-6 weeks) and maintenance schemes (300mg intravenously, every 8 weeks).

Epidemiological and clinical data from every patient will be recorded prospectively. Disease activity at weeks 0, 2, 6 and 14 weeks will be evaluated through validated clinical scores, biological parameters and fecal biomarkers.

At week 14 response to the treatment will be evaluated by ileocolonoscopy or enteroMRI.

Peripheral blood will be obtained from every patient at baseline, before the third infusion of VDZ (6th week) and before the first maintenance dose (14th week).

Blood lymphocytes will be isolated and multicolor flow cytometry will be performed on stored circulating memory T cells.

Percentage and absolute values of circulating CD4+ and CD8+ α4β7+ memory T lymphocytes as well as several surface markers related to their activation state (HLA-DR, CD25), Th17 phenotype (IL23R, CCR6, intracellular IL17A) and Th1 phenotype (INFγ)will be assessed on α4β7+ memory T cells.


Eligibility Criteria:
Inclusion Criteria:

* Ulcerative colitis or Crohn's disease diagnosis established by Lennard-Jones criteria
* Clinically active disease confirmed by endoscopic or radiologic criteria Magnetic Resonance Image (MRI)
* \>18 years of age
* Intolerant, refractory or secondary loss of response to anti-Anti-tumour necrosis factor (TNF) alfa treatment.

Exclusion Criteria:

* Crohn's disease with perianal disease
* Active Tuberculosis
* Current infections (including Clostridium difficile and Cytomegalovirus)
* History of cancer, including hematologic malignancy and solid tumours within 5 years before
* History of demyelinating disease
* Pregnancy or breastfeeding
Efficiency Study to Investigate Blonanserin in Treatment of Schizophrenia When Compared With Risperidone

A Randomized, Double-blinded, Double-dummy, Parallel-controlled and Multicenter Clinical trial to Investigate Blonanserin in Treatment of Schizophrenia when compared with Risperidone

A Randomized, Double-blinded, Double-dummy, Parallel-controlled and Multicenter Clinical trial to Investigate Blonanserin in Treatment of Schizophrenia when compared with Risperidone

Trial drugs:

* Blonanserin group: Blonanserin tablets+Risperidone mimetic tablets
* Risperidone group: Risperidone tablets+Blonanserin mimetic tablets

Objectives of Study :

To evaluate the efficacy and safety of Blonanserin in treating schizophrenia

Eligibility Criteria:
Inclusion Criteria:

* Subject met Diagnostic and Statistical Manual of Mental Disorders(DSM)-IV-Text Revision(TR) criteria for a primary diagnosis of schizophrenia
* Patients are 18≤age\<65 years of age on the day when informed consent is obtained.
* Subject had a PANSS total score ≥70 and 120≥ at Screening
* Subject had a score ≥4 on the PANSS at Screening and Baseline.
* Subjects are willing and able to comply with study protocol including treatment in hospital.
* Subjects or their legal guardians have signed the written informed consent form.

Exclusion Criteria:

* The subject was treatment with other Investigate product within 30 days.
* Subject had a history of treatment with long-acting drug for anti schizophrenia within 56 days.
* Subject had a history of treatment with clozapine within 28 days.
* Subject With parkinson disease,etc
Oral Sildenafil and Intravenous Milrinone on Postoperative Pulmonary Hypertension

Pulmonary hypertension (PH) is a consequence of an increase in pulmonary vascular resistance (PVR), pulmonary blood flow, pulmonary venous pressure, or a combination of these elements. Pulmonary arterial hypertension is a frequent complication of congenital heart disease, particularly in patients with systemic-to-pulmonary shunts. Persistent exposure o f the pulmonary vasculature to increased blood flow and pressure may result in vascular remodeling and dysfunction. This leads to increased pulmonary vascular resistance and, ultimately, to reversal of the shunt and development of Eisenmenger's syndrome. It may be more appropriate to define pulmonary hypertension according to the ratio of MPAP to mean systemic arterial pressure (MPAP/MAP) because children may have a low mean systemic blood pressure. MPAP/MAP ratio of \< 0.25 is normal, a ratio of 0.33-0.5 indicates moderate pulmonary hypertension, and a ratio of \> 0.5 is indicative of severe pulmonary hypertension

30 Patients were randomly allocated in two equal groups; group MS (received intravenous milrinone and oral sildenafil) and group M (received only intravenous milrinone). Demographic data, patient's clinical data and different intraoperative times were recorded. In 1st postoperative 24 hours, we recorded; hemodynamic parameters \[mean pulmonary arterial pressure (MPAP), mean systemic arterial pressure (MAP), heart rate, central venous pressure\]. We calculated MPAP/MAP and inotropic score. The incidence of pulmonary hypertensive crisis, side effects of studied drugs and complications related to pulmonary artery catheter were recorded.

Eligibility Criteria:
Inclusion Criteria:

- Thirty patients in the age range 2-24 months scheduled for surgical closure of ventricular septal defect (VSD) associated with postoperative pulmonary hypertension \[diagnosed in all patients by preoperative echocardiography and confirmed invasively by the pulmonary catheter before transfer to ICU by Mean Pulmonary Arterial Pressure (MPAP) \> 25 mmHg or Mean Pulmonary Arterial Pressure (MPAP) /Mean Systemic Arterial Pressure (MAP) \> 0.33\] were enrolled in this study.

Exclusion Criteria:

* Patients with pre-existing obstructive lung disease, mitral valve disease, left ventricular dysfunction, and patients receiving preoperative pulmonary vasodilators
Iron Deficiency Anemia in Twin Pregnancies

All pregnant women with twin pregnancies were given oral iron according to the current recommended dose. Blood routine and ferritin were monitored during pregnancy to understand the therapeutic effect of oral iron on iron deficiency anemia and iron deficiency in pregnant women with twin pregnancies

All pregnant women with twin pregnancies were given oral iron according to the current recommended dose. Blood routine and ferritin were monitored every 2-4 weeks during pregnancy to understand the therapeutic effect of oral iron on iron deficiency anemia and iron deficiency in pregnant women with twin pregnancies.After delivery, we will test the neonatal ferritin and hemoglobin status. Our aim was to investigate the effects of iron supplementation during twin pregnancy on maternal and neonatal ferritin and anemia.

Eligibility Criteria:
Inclusion Criteria:

* Chinese
* Pregnant women with twin pregnancies

Exclusion Criteria:

* Single pregnancy
* Types of anemia other than iron deficiency anemia
Hypoglycemia Associated Autonomic Failure in Type 1 DM, Q2

Alprazolam (Xanax) will blunt the body's ability to defend itself from low blood sugar.

Due to the fundamental importance of glucose as a cerebral fuel, a complex and redundant counterregulatory response to hypoglycemia exists in man. Some studies have shown that prior activation of GABA(A) receptors may result in blunting of counterregulatory responses during next day hypoglycemia.

The Specific Aim is to determine if repeated activation of GABA(A) receptors using Alprazolam will result in blunting of neuroendocrine, ANS and metabolic counterregulatory mechanisms during next day hypoglycemia in T1DM and healthy man.

Eligibility Criteria:
Inclusion Criteria:

* 16 (8 males, 8 females) Type 1 diabetes patients aged 18-45 yr.
* 16 (8 males, 8 females) healthy controls aged 18-45 yr.
* HbA1c \> 7.0% (Type 1 diabetes patients)
* Had diabetes for 2-15 years (Type 1 diabetes patients)
* No clinical evidence of diabetic tissue complications (Type 1 diabetes patients)
* Body mass index 21-30 kg · m-2
* Normal bedside autonomic function
* Normal results of routine blood test to screen for hepatic, renal, and hematological abnormalities
* Female volunteers of childbearing potential: negative HCG pregnancy test

Exclusion Criteria:

* Prior history of poor health: any current or prior disease condition that alters carbohydrate metabolism and prior cardiac events and/or evidence for cardiac disease
* Hemoglobin of less than 12 g/dl
* Abnormal results following screening tests
* Pregnancy
* Subjects unable to give voluntary informed consent
* Subjects with known liver or kidney disease
* Subjects taking steroids
* Subjects taking beta blockers
* Subjects on anticoagulant drugs, anemic, or with known bleeding diseases
the Role of Gum Chewing in Regaining Bowel Motility in Patients Undergoing Cesarean Section

Aim:to evaluate the efficacy of postoperative gum chewing on the recovery of bowel motility after cesarean section.

this study will be conducted on 162 patients undergoing cesarean section in obstetrics and gynecology department at Kasr el Ainy Hospital,Kairo university.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-35

  --Spinal anesthesia
* Pfannensteil incision

Exclusion Criteria:

* History of drug consumption especially opioids
* water and electrolyte disturbance
* History of abdominal surgery except cesarean section
* Intra and severe post operative complications
* diabetes
* Pre-eclampsia
* Hypothyroidism
* Muscular and neurological disorder
* Inability to chew gums
Fetal Heart Rate Characterization Using Innovative Advanced Non-invasive Technology

The purpose of the study is to examine the effectiveness and reliability of fetal heart rate monitoring by the Oxitone device.

Today, fetal monitoring is carried out with an external approach using a Doppler transducer placed on the mother's abdomen or with an internal approach only after water breaks and during active labor by connecting an electrode to the head of the fetus.

Oxyton's technology collects various physiological indicators and calculates an estimation of the fetal pulse. This monitoring method has a wide potential for use as part of pregnancy monitoring and perhaps even during childbirth.

Fetal heart rate will be measured in pregnant women in the third trimester of pregnancy with one fetus. The patients will wear the Oxitone device at the same time as Doppler monitoring in the hospital. An analysis of the data will be performed in comparison to the current accepted fetal monitor.


Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals between the age of 18-50

Exclusion Criteria:

* Clotting disorders, diabetes, currently taking psychotropic medications
A Safety, Tolerability, PK, and PD Study of Once Weekly ISIS-FGFR4RX SC in Obese Patients

The purpose of this study is to to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ISIS-FGFR4RX.


Eligibility Criteria:
Inclusion Criteria:

1. Must have given written informed consent (signed and dated) and any authorizations required by local law and be able to comply with all study requirements
2. Male or female patients between the age of 18-65 years, inclusive

   * Females: Must be post-menopausal (defined as 12 months of spontaneous amenorrhea in females \> 55 years of age or, in females ≤ 55 years, 12 months of spontaneous amenorrhea without an alternative medical cause and FSH levels in the postmenopausal range for the laboratory involved)
   * Males: Surgically sterile, abstinent or if engaged in sexual relations with women of childbearing potential, patient is utilizing an acceptable contraceptive method during and for 5 months after the last dose of ISIS 463588 or placebo (Study Drug)
3. Body Mass Index (BMI) between 30.0 and 40.0 kg/m2, inclusive
4. Patients who are willing to comply with all scheduled visits, treatment plans, laboratory tests and other study procedures
5. Agree to abstain from alcoholic beverages for at least 48 hours prior to clinic visits
6. Agree to maintain current diet and exercise regimen from Screening until End-of-Study

Exclusion Criteria:

1. Clinically significant abnormalities in medical history (e.g., previous acute coronary syndrome within 6 months of Screening, major surgery within 3 months of Screening) or physical examination
2. Positive test for HIV, hepatitis B or C at Screening
3. Hypothyroidism or Hyperthyroidism
4. Weight change \> 5% in the 3 months prior to Screening
Prostate Cancer Patients Treated With Alternative Radiation Oncology Strategies

As the most common male carcinoma, prostate cancer is a major tumor entity in oncology. In addition to definitive radiotherapy, surgical procedure is considered to be an oncologically equivalent therapeutic alternative for non-metastatic malignancies in the primary setting. However, a subsequent radiotherapy of the prostate bed is often necessary, which takes place as an "adjuvant" treatment immediately after surgery or in the course of a repeated increase in PSA and usually extends over several weeks. For the primary situation (without previous surgery), several randomized phase III clinical trials have shown that it is possible to shorten radiotherapy by increasing the single dose (called hypofractionation). In the context of two prospective Phase II studies, which were carried out in Heidelberg, it has since been shown that hypofractionation with both photons and protons is safe and feasible even in the postoperative situation.

The current, prospective and randomized PAROS study is now intended to demonstrate a multicentric phase III study as an improvement in the quality of life caused by rectum toxicity (primary endpoint) by the use of protons. The oncological non-inferiority of hypofractionated radiotherapy after surgery is a secondary endpoint.


Eligibility Criteria:
Inclusion Criteria:

* histology-proven prostate cancer with Gleason Score and PSA-value;
* indication for prostate bed irradiation (adjuvant/ salvage) after prostatectomy;
* Karnofsky-Index ≥ 70%
* age ≥ 18 years

Exclusion Criteria:

* androgen deprivation therapy
* lymphatic spread
* macroscopic tumor/ R2
* stage IV (M1)
* previous irradiation
Temporary Peripheral Nerve Stimulation System for Osteoarthritis of the Knee

The purpose of this study is to demonstrate the treatment outcomes of patients with chronic knee pain secondary to osteoarthritis that have received a temporary peripheral nerve stimulation system.


Eligibility Criteria:
Inclusion Criteria:

* Age of 21 and older
* Will receive a temporary PNS system for the management of chronic knee pain secondary to osteoarthritis
* Be capable of subjective evaluation, able to read and understand English-written questionnaires, and able to read, understand and sign the written informed consent in English
* Be willing and capable of giving informed consent
* Be willing and able to comply with study-related requirements, procedures, and scheduled visits

Exclusion Criteria:

* No knee pain at rest
* Same nerve targeted for both Radiofrequency Ablation (RFA) and Peripheral Nerve Stimulation (PNS) in less than 6 months post RFA, if applicable
* Pregnancy
* History of repetitive skin infections
* Vulnerable populations (e.g., prisoners, minors, students, employees)
* Any other condition that may interfere with the ability to participate in a clinical trial (e.g., anatomy that may interfere with lead placement, nerve damage, compromised immune system, uncontrolled diabetes)
* Confounding conditions such as lumbar radiculopathy
* Deep brain stimulation system, implanted active cardiac implant (e.g. pacemaker of defibrillator), or any other implantable neuro-stimulator whose stimulus current pathway may overlap the SPRINT system.
* Be involved in an injury claim under current litigation
* Be a recipient of temporary Social Security Disability Insurance (SSDI) benefits due to chronic pain
* Have a pending or approved worker's compensation claim
Stereotactic Radiotherapy for Brain Metastases

Stereotactic radiotherapy is an innovative treatment enabling to target accurately brain metastases. The aim of this study is to evaluate tumoral response and acute and late toxicity of this treatment.


Eligibility Criteria:
Inclusion Criteria:

* Situation 1: in case of several cerebral metastases. In this case, the maximum of cerebral metastases is 3, and the maximum diameter of the largest can not exceed 3 cm. The other two ones can not exceed 1 cm or even maximum 2 cm in diameter for one of the two. The same principle will remain valid in the presence of 2 metastases.
* Situation 2: in the case of a single metastasis, the diameter should be a maximum of 3 cm
* Situation 3: in case of metastasis supposed to be radioresistant (renal adenocarcinoma, sarcoma, melanoma ...), only a single metastasis of not more than 3 cm in diameter will be accepted. A primary resection followed by radiotherapy will be preferred.
* Situation 4: In case of localization near a structure at risk (contact with anterior optical pathways, central nuclei or the brainstem or localization in these structures), a maximum number of 3 metastases may be accepted. However, that included in or close to the risk structure can not exceed 2 cm in diameter and the other two, located outside a risk structure will have a diameter not exceeding 1 or even maximum 2 cm.
* Situation 5: single metastasis of maximum 3 cm in a context of re-irradiation, the whole encephalon having already received the dose of 10 X 3 Gy or its biological equivalent of dose.
* Signed informed consent

Exclusion Criteria:

* Impossibility of performing an MRI or a CT-scan of the brain with injection of contrast agent
* Metastases greater than 3 cm at the start
Explore the Relationship Between Platelet Count and Bleeding Score in ITP

Assessment of bleeding scores in immune thrombocytopenia purpuria to explore the relationship between platelet count and bleeding score in immune thrombocytopenia purpura (ITP) and compare the clinical practicability of bleeding grading systems with adult patients with ITP.

Immune thrombocytopenia purpura (ITP) is an autoimmune hemorrhagic disease, characterized by a decreased platelet count ( \< 100\*109) and suppressed platelet development . The incidence of ITP increases with age, with an incidence rate of 20-40/ million adults (over 18 years old) /year and higher in the people over 60 years old . The main clinical manifestations were bleeding symptoms, but heterogeneity between manifestations was noted. Severe thrombocytopenia is considered as a risk factor for bleeding in ITP, but patients with moderate or even mild thrombocytopenia can also experience severe bleeding, which seems like a disproportionate performance

. Bleeding is one of the leading causes of death in patients with thrombocytopenia . Bleeding manifestations in ITP with mild mucocutaneous to life-threatening bleeding, and prediction of severe bleeding is instructive to the management of thrombocytopenia.

Bleeding assessment tools, such as ITP Bleeding Assessment Tool (ITP-BAT), ITP Bleeding Scale (IBLS) and Khellaf bleeding score, have been developed and studied in a variety of clinical settings for diagnosis and to evaluate the severity of bleeding.

In this study, investigators retrospectively assessed the relationship between platelet count and bleeding score in patients with ITP and compared the clinical aspects of existing ITP bleeding score systems .

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of primary ITP .

Exclusion Criteria:

* Malignancy disease
* Virus infection:

  * HIV
  * Hepatitis B virus
  * Hepatitis C virus
* Pregnancy.