cyrilzakka/clinical-trials huggingface dataset:
Comparison of Sclerotherapy Agents Used for Rectal Prolapse Treatment in Children

Introduction Patients with rectal prolapse are treated with injection sclerotherapy, which is the most often used first-line surgical technique. Injection sclerotherapy has a success rate of 90-100% in youngsters, according to certain studies. Objective To compare the outcome of injection sclerotherapy using 5% Phenol in almond oil, 15% hypertonic saline and 50% dextrose water in the treatment of rectal prolapse in children.

Materials and Methods Study design: Randomized control trial. Setting: Paediatric surgery department, King Edward medical university, Mayo Hospital Lahore. Duration: Twelve months after approval of synopsis. Data collection procedure: After ethical approval, all the patients with rectal prolapse fulfilling inclusion criteria admitted. Routine history, thorough clinical examination and routine preoperative investigations was done. Patients were randomly allocated to group A, B or C using the lottery method. Group A patients were given injection sclerotherapy with 5% phenol in almond oil; Group B patients were given injection sclerotherapy with 15% hypertonic saline and group C patients were given injection sclerotherapy with 50% dextrose water solution. Under general anesthesia and patient in lithotomy position, 2-3 ml of sclerosing agent was injected into the submucosa at 3 sites around the circumference preferably at 3,6 and 9'o' clock positions about 2-3 cm above dentate line. The injection was performed under vision, using a speculum while LP needle was passed through the perianal skin. All patients were kept under observation during the hospital stay and discharged on same day and followed on week 1 and after 3 months for recurrence of rectal prolapse, fecal incontinence, perianal abscess and anal stenosis according to the operational definition.

Eligibility Criteria:
Inclusion Criteria:

• Patients with partial or complete rectal prolapse of either gender presenting to paediatric surgery department, Mayo Hospital Lahore, under 13 years of age.

Exclusion Criteria:

* Patients of rectal prolapse due to ulcerative colitis and crohn's disease documented in medical record.
* Patients with previous history of surgery on pelvic floor documented in medical record.
* Caudaequina syndrome, neural tube defects, Sacrococcygeal teratoma, Hirschsprung,s disease, congenitalmega colon and rectal polyps documented in medical record. -
Study of Clonidine Efficacy for the Treatment of Impulse Control Disorders in Parkinson's Disease:

Noradrenergic system is involved in impulsivity in the general population and is altered in Parkinson's disease (PD) in the early stages of the disease. Thus, targeting this system could be of interest in impulse control disorder (ICD). Acting on the noradrenergic system is possible using clonidine, an α2 adrenergic agonist largely used in hypertension treatment and that induces a decrease of NADR release. Thus, our aim is to conduct a proof of concept study evaluating the efficacy and safety of clonidine on ICD in PD. This study is a multicenter, randomized, double-blind, placebo-controlled in parallel group clinical trial.


Eligibility Criteria:
Inclusion Criteria:

* Patients with PD according to MDS (movement disorders society) criteria for at least one year
* Patients with ICD with a QUIP-RS score ≥10 and/or at least one of the sub-scores in the following range: Pathological gambling between \>6 and 12; Pathological gambling between \>8 and 12; Hypersexuality between \> 8 and 12; Eating between \> 7 and 12. The use of "lower" margins will guarantee that patients will present behavioral disturbances severe enough to justify clonidine treatment. On the other hand, the use of "upper" margins will guarantee that the patients included in the trial will not suffer from ICD too severe to ethically participate to a placebo controlled study.
* Weight between 40 and 95kg
* Stable antiparkinsonian medication since at least 2 months before randomization and medication supposed to remain stable during the study
* ICD onset after Parkinson's disease onset and after initiation of dopaminergic drugs
* No signs of dementia (Montreal Cognitive Assessment, MOCA \>20);
* No lactose intolerance which may compromise the tolerance of the placebo;
* Patients with health insurance
* Patients without judicial protection measure except directly linked to ICD
* For women of childbearing potential, an effective contraception method for at least 2 months before randomization (as implants or oral oestro-progestative contraceptives), condom use for men during the study. βHCG dosage in urine should be negative at randomization for women.

Exclusion Criteria:

Patients with major depression (BDI \>19);

* Patients with another parkinsonian syndrome (Parkinson "plus" or vascular Parkinsonism)
* Orthostatic hypotension
* Patients with swallowing disorders that may prevent oral medication,
* Contraindication to clonidine: Hypersensibility; Severe bradyarythmia due to a cardiac disease
* Patients receiving a treatment potentially interacting with clonidine
* Patients with Raynaud's disease or obliterating thromboangiitis
* Patients With Heart failure or severe coronary artery disease
* Patients with a drug treatment having a potential interaction with clonidine (see list, appendix 2);
* Presence of renal failure (Cockcroft-Gault at inclusion visit\<30 ml/min/1,73m2);
* Patients with a present or past history of addiction (apart ICD) or with a substance abuse (except Tabaco)
* Pregnant or lactating women
* Already participating in another biomedical research project
Clinical Trial Study About Human Adipose-Derived Stem Cells in the Liver Cirrhosis

The aim of the investigators study was to investigate the safety and efficacy of autologous ADSCs for the clinical treatment of liver cirrhosis.

One milliliter of cell suspension will be injected intrahepatically under sonographic guidance using a gauge-18 needle.

Eligibility Criteria:
Inclusion Criteria:

1. Liver cirrhosis investigators with age 20 to 80 years (both inclusive).
2. Investigators without Mandatory Communicable Disease (HBV, HCV, HIV, syphilis)
3. Investigators without rare disorder
4. Coagulation normalities
5. Investigators without autoimmune disorder
6. Investigators without Acquired Immune Deficiency Syndrome
7. Investigators without cancer
8. Investigators BMI \> 15

Exclusion Criteria:

1. Pregnant women
2. Investigators with acute stroke in one month and unconsciousness
3. Investigators with acute myocardial infarction or acute heart failure
4. Investigators with serious liver dysfunction and coagulation dysfunction and ascites mild higher
5. Investigators with acute respiratory failure or pneumonia
6. Kidney Failure: BUN \> 50
7. Anemia: Hematocrit \< 25
8. Investigators diagnosed with liver cancer or liver metastatic carcinoma
9. Investigators with liver abscess
10. Investigators with acute Hepatitis
11. Investigators with acute infective
12. Liver cirrhosis patients with HBV or HCV
13. Investigators diagnosed with carcinoma and receiving treatment
14. Investigators with Schizophrenia or melancholia
15. Investigators received serious surgical operations in 3 months
16. Investigators unable to control hypertension (SBP \> 180 mmHg, DBP \> 110 mmHg) or diabetes (AC sugar \> 200 mg/dl)
17. Others can't fit into the trial evaluate by investigator
Improving Outcomes for Patients Requiring Oral Bowel Preparation for Colonoscopy

Study hypothesis The overall aim of this study is to compare two bowel preparations that are used prior to a colonoscopy procedure.

The principal research questions are:

1. Does the use of a low residue diet increase patient concordance to the bowel preparation instructions?
2. Does the use of a low residue diet decrease the adequacy of assessment of the mucosa?
3. Does the use of a low residue diet increase the willingness of patients to undertake repeated examination as is required for disease follow-up?
4. Does body weight affect perceived tolerability of either group?


Eligibility Criteria:
Inclusion Criteria:

* Patients attending for Colonoscopy.
* Patients referred for colonoscopy via General Practitioner.

Exclusion Criteria:

* Individuals who would not fully understand trial purpose (assessed by a cognisance scale if required)
* Previous episodes of total or partial small bowel obstruction
* Previous colonic surgery
* Known swallowing disorder
* Pregnancy
* Extremes of age (Less than 16 or greater than 80)
* Small Intestine disorders
* Renal Insufficiency (Serum Creatinine\> 110)
* Congestive Heart failure
* Presence of ascites
* Severe Colitis
Assessment of Clinical Effects of Coenzyme Q10 Levels in COVID-19 Patients in Intensive Care Unit

The study will be done in Hacettepe University Anesthesiology and Reanimation Intensive Care Unit. The investigators will accept COVID-19 diagnosed or suspected patients to the ICU. In the first day of hospitalization and after that once a week, the investigators will take blood samples from the patients to evaluate Coenzyme q10 levels. Our hypothesis is that there is a relationship between low coenzyme q10 levels and poor clinical outcome.


Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

* being under the age of 18
* being pregnant
* patient refusal
Cost-Effectiveness of Routine Follow-up Visits in Patients With a Pacemaker: The Followpace Study

The overall objective of the study is to quantify the true prognostic value and cost-effectiveness of routine follow-up visits in patients who receive an approved pacemaker of any type for the first time.

Specific objectives :

* To determine the incidence of complications occurring in the first year after implantation of a pacemaker.
* To determine the quality of life at one year after pacemaker implantation in comparison with the quality of life before implantation.
* To determine which baseline (patient and pacemaker related) characteristics measured during implantation are prognostic predictors for the occurrence of complications and quality of life after one year.
* To determine which characteristics measured during follow-up visits truly have added predictive value, and to what extent.
* To determine to what extent responsibilities for pacemaker check-up can be safely delegated to non-cardiologists (e.g. pacemaker technicians or manufacturers' delegates).

Eligibility Criteria:
Inclusion Criteria:

* Each patient aged 18 years or over receiving a pacemaker for the first time in one of the participating Dutch pacemaker implanting centers, is a potential candidate for the study.

Exclusion Criteria:

* Patients are not eligible if they refuse to sign informed consent on use of personal medical data.
* Patients who are taking any investigational (new) drug or have a non-approved or investigational pacemaker system which requires unusual follow-up regarding the pacemaker
* Patients having diseases that are likely to cause death or significant morbidity during the study period such as neoplasia and immune, infectious or degenerative diseases will be excluded.
Synbiotics in Patients at RIsk fOr Preterm Birth

Prematurity remains the main cause of death and serious health problems in new-borns. Besides the need for hospitalization and medical interventions in the first weeks or months of the new-borns' life, prematurity can cause long-lasting health problems (e.g. multiple hospital admissions, developmental delay, learning difficulties, motor delay, hearing or eye problems, ...). Moreover, prematurity places an enormous economic burden on the society. Aside from the medical problems and the financial cost, the emotional stress and psychological impact on the parents, siblings and other family members should not be underestimated.

Previous preterm delivery (before 37 weeks of pregnancy) increases the risk for recurrent preterm delivery in a subsequent pregnancy. Therefore, these women should be considered as 'high risk' for preterm birth.

Infections ascending from the vagina may be an important cause of preterm delivery in certain cases. Some women have an abnormal vaginal microbiome and are therefore at risk for infections and preterm birth. On the other hand, the vaginal flora is more stable and resistant to infections in healthy pregnant women who deliver at term (after 37 weeks of gestation).

Synbiotics are a mixture containing probiotics and prebiotics. Probiotics are living bacteria with potential beneficial effects that can be used safely in pregnancy, while prebiotics are consumed by the bacteria. It is known that probiotics, when used for a long period of time, can maintain a healthy and stable vaginal flora that may protect against infections. In this study, pregnant patients with a history of preterm birth will be included in the first trimester of pregnancy to start with synbiotics or placebo. The investigators will examine the effect of synbiotics on the vaginal flora and on the pregnancy duration. The hypothesis is that synbiotics, when started early in the pregnancy, can change the disturbed vaginal flora into a stable micro-environment.


Eligibility Criteria:
Inclusion Criteria:

1. Signed written informed consent must be obtained before any study assessment is performed;
2. 18 years of age or older;
3. Singleton pregnancy;
4. Pregnancy consultation between 8 and 10 weeks gestation.
5. At least one of the following risk factors for spontaneous preterm birth:

   * Prior spontaneous preterm birth, defined as delivery between 24 and 36 weeks following PPROM, preterm labor or cervical insufficiency
   * PPROM ≤36 weeks in previous pregnancy
   * Prior spontaneous second-trimester pregnancy loss, defined as PPROM, preterm labor or cervical insufficiency with birth between 14 and 24 weeks.

Exclusion Criteria:

1. Patients who are already using pro-, pre- or synbiotics and not willing to stop
2. Multiple pregnancy
3. Need for primary (type 1) cerclage
4. Inflammatory bowel disease
5. Known congenital uterine anomaly
6. History of LLETZ conization
the Inhaled β2-adrenergic Receptor Agonist for Transient Tachypnoea of the Newborn (the REFSAL Trial)

Clinical trial evaluating the efficacy and safety of salbutamol for the treatment of neonates with a gestational age between 32 and 42 weeks with transient tachypnoea of the newborn (TTN).

Multicentre, double-blind, phase III trial will include infants with a gestational age between 32 and 42 weeks and respiratory disorders treated in neonatal intensive care units in Poland. Infants will be enrolled no later than 24 h after birth and will be randomly assigned (1:1) to receive nebulized salbutamol with nCPAP or placebo (nebulized 0.9% NaCl) with nCPAP. The primary outcome is the percentage of infants with TTN who develop PPHN.

Eligibility Criteria:
Inclusion Criteria:

1. Gestational age at birth between 32 and 42 weeks.
2. Respiratory disorders (tachypnea and expiratory grunting) lasting longer than 15 minutes after birth, or present for at least 15 minutes in the first six hrs of life, or a need for non-invasive respiratory support between birth and six hrs of life.
3. Available chest radiographs obtained within six hrs after birth.
4. Available parameters of the acid-base balance (blood pH, partial pressure of O2 and CO2, base excess) and blood serum ionogram for Na+, K+, Ca2+ evaluated in the umbilical cord blood sample.

Exclusion Criteria:

1. Need for intubation directly after birth or perinatal asphyxia, defined as abnormal acid-base parameters detected in an umbilical cord blood sample (pH \<7.0 or base excess \< -14 mmol/L).
2. Multiple apnea-brady that require immediate intubation before a trial of NIV
3. Age \>24 h.
4. Meconium aspiration syndrome.
5. Air leak syndrome.
6. Congenital heart disease.
7. Congenital diaphragmatic hernia.
8. Other severe congenital malformations and genetic disorders (diagnosed before and after birth) associated with increased risk of respiratory failure.
9. The need for a surfactant administration immediately after birth, regardless of the method of its administration (respiratory distress syndrome - RDS)
Improving Tissue Repair After Injury in the Muscle-tendon Interface Muscle Tissue Injury

The study is a 2-week human study where 40 patients who are scheduled to undergo reconstructive knee surgery are randomized to administration of GH or placebo following or without neuromuscular electrical stimulation of hamstring muscles.The overall aim is to determine, the role of muscle connective tissue protein synthesis in muscle injury and repair.


Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women scheduled to undergo reconstructive knee surgery
* BMI 18-35

Exclusion Criteria:

* Former or current use of growth hormone or anabolic steroids
* Use of corticosteroids in the past 3 months
* Use of any medication known to affect muscle or tendon turnover
* Former participation in a study using deuterated water
* Chronic diseases
Exhaled Nitric Oxide in Respiratory Syncytial Virus (RSV) Bronchiolitis: a Pilot Study

The fraction of exhaled nitric oxide (feNO) in expired air is a reliable measure of airway inflammation. Some research experiments have demonstrated stimulation of nitric oxide production in respiratory epithelial cells infected with RSV.

The principal aims are to determine if the fraction of exhaled nitric oxide (feNO) is elevated in hospitalized pediatric patients with viral lower respiratory illness and to determine if there is a difference in feNO level between RSV and non-RSV infection.

NO may play a role in the association between RSV, airway reactivity, and airway inflammation.

This is a prospective, pilot study that will noninvasively measure feNO in children 0-4 years of age admitted to Winthrop University Hospital, as well as controls (children in the same age range without respiratory conditions and who are well enough to perform the test). Hospitalized children will be tested for RSV (enzyme immunoassay (EIA) \& DFA) and via direct fluorescent antigen technique (DFA) for influenza A \& B, parainfluenza, human metapneumovirus and adenovirus.

Method of feNO measurement will utilize the offline options for preschool children \& infants appropriate for age as described in the 2005 Joint Statement of the American Thoracic Society \& the European Respiratory Society when discussing tidal breathing techniques with uncontrolled flow rate Offline exhaled air can be collected via a mouthpiece or a face mask connected to a non-re-breathing valve that allows inspiration of NO-free air from an NO-inert reservoir to avoid contamination by ambient NO. Exhaled breath samples are collected into an NO-inert bag fitted with the expiratory port once a stable breathing pattern is present.

The results of all 3 groups will be compared: control, RSV positive and RSV negative samples.


Eligibility Criteria:
Inclusion Criteria:

* Admitted subjects with diagnosis of bronchiolitis, viral pneumonia or other significant respiratory viral infection

Exclusion Criteria:

* asthma/RAD
* recurrent wheezing
* "recurrent bronchiolitis"
* allergic rhinitis
* atopy
* chronic lung disease
* hypertension
* heart failure
* pulmonary hypertension
* primary ciliary dyskinesia
* bronchiectasis
* alveolitis
* lung transplant rejection
* pulmonary sarcoidosis
* chronic cough (i.e. greater four weeks)
* systemic sclerosis
* hypersensitivity
* cystic fibrosis
* HIV
* sickle cell anemia
* cardiac pulmonary bypass
* liver cirrhosis
* alpha-1 anti-trypsin disease
* interstitial lung
The Clinical Effect of MK0476 With Concomitant Administration of and Removal of Inhaled Beclomethasone in Asthmatic Patients (0476-029)

This study will investigate the additive effect of montelukast (MK0476) taken along with inhaled beclomethasone versus inhaled beclomethasone alone.


Eligibility Criteria:
Inclusion Criteria:

* Female patients tested negative for pregnancy and agreed to use appropriate contraceptives through out the study
* Patient was a nonsmoker
* Patient was in good general health (except for asthma)

Exclusion Criteria:

* Patient was hospitalized
* Patient was female who was less than 8 weeks postpartum or breast feeding
* Patient planned to move or vacation away during the study
* Patient had major surgery within 4 weeks the past 4 weeks
* Patient has donated blood or participated in a clinical trial within the past 4 weeks
* Patient was a regular user or recent abuser of alcohol or illicit drugs
* Patient was 40% over or under normal weight for height
Effect Of Carvedilol Versus Metoprolol On Glycemic Control In Patients With Type II Diabetes And Hypertension

Evaluation of the effect of two different antihypertensive treatments on control of glucose in Type II diabetic patients with high blood pressure


Eligibility Criteria:
Inclusion criteria:

* Patients at screening must be insulin producing Type II diabetics (C peptide positive).
* Patients must have a history of mild to moderate hypertension (140-179 systolic blood pressure; 90-1-9 diastolic blood pressure)
* Patients must be on a stable regimen of ACE (angiotensin converting enzyme) / ARB (angiotensin receptor blocker) treatment alone or in combination with other treatments.
* Patients must be on stable antidiabetic regimen (drug treated or diet alone).
* Patient''s laboratory result for HbA1c must be 6.5 - 8.5 (drug treated) or 6.5 - 7.5 (diet alone).

Exclusion criteria:

* Patients using beta-blocker therapy.
Quit IT: Preliminary Testing of a Web-based, 3D Coping Skills Game to Increase Quitting Self-Efficacy for Maintaining Smoking Abstinence Following Hospitalization

The purpose of this study is to develop and test a web-based game called Quit It that is designed to help smokers who have quit smoking cope with any smoking urges they may have. The purpose of the game is to help people quit and stop people from smoking again.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old
* English-speaking
* Cancer (solid tumor) diagnosis or mass suspicious of cancer within past six months as per clinical judgment
* Cancer treatment expected plan to include hospitalization for surgical treatment for at least 2 days at MSKCC as per the patients clinical team
* Referred to MSK's Tobacco Cessation Program
* Patient-reported cigarette use within the past 30 days
* Have sufficient sensory acuity (i.e., auditory, visual) and manual dexterity to use a computer game as per judgment of clinician or consenting professional
* Can be reached by telephone

Exclusion Criteria:

* Distant metastatic disease at the time of enrollment
* Major psychiatric illness or cognitive impairment that in the judgment of the investigator would preclude study participation
* Any patients who are unable to comply with the study procedures as determined by the study investigators