cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Educational Intervention as Supporting Element in the Treatment of Functional Constipation in Children

The purpose of this study is to determine whether educational intervention (recommendation of adequate fluid intake) is effective as an element supporting the treatment of functional constipation in children.

Constipation is a common condition in children which affects around 10% of the paediatric population. In 95 % cases it is a functional disorder of the digestive tract, without any organic cause. Recommendations of lifestyle modifications accompanying pharmacological treatment of constipation are very popular among healthcare providers, although there is limited data concerning non-pharmacological treatment methods of this condition. Adequate for age fluid intake is now recommended for patients with constipation. Further research is needed to form stronger recommendations in the future. The purpose of this study is to determine whether educational intervention (recommendation of adequate fluid intake) is effective as an element supporting the treatment of functional constipation in children.

Eligibility Criteria:
Inclusion Criteria:

Children with functional constipation diagnosed based on Rome IV criteria

Exclusion Criteria:

1. Children with organic causes of constipation; eg, anorectal malformations, or Hirschsprung's disease
2. Children who fulfil the criteria of Irritable Bowel Syndrome
3. Significant, unstabilised chronic health conditions requiring major drug adjustment during the last 3 months.
4. Unintentional weight loss greater than or equal to 5% of their body weight within the last 3 months
5. Recurrent or unexplained fevers
6. History of abdominal surgery involving the luminal gastrointestinal tract, except appendectomy, or hernia repairs
7. Concomitant use of drugs that are known to affect gastrointestinal motility
8. Established diagnoses of autism spectrum disorders
9. Mental retardation
10. Children who are exclusively breastfed
11. Non-retentive faecal incontinence
Community Trial of Zinc Supplementation on Preschool Child Mortality and Morbidity in Southern Nepal

The purpose of this study is to determine whether daily supplementation of young children in Nepal with either zinc, iron-folic acid, or both can reduce mortality and morbidity. Young children in Nepal have numerous nutritional deficiencies and high rates of morbidity and mortality. Zinc and/or iron supplementation may be a cost-effective method for reducing these risks.

Mortality rates among preschool age children in Nepal and many other developing countries remain high despite significant progress made over the past 20 years. There remain significant nutritional deficiencies in these populations, especially important are vitamin and mineral deficiencies.

Comparisons: In this study, we are comparing the morbidity and mortality experience for children 1-36 months of age randomized to one of four daily supplementation regimens: placebo, zinc alone, iron-folic acid alone, zinc + iron-folic acid.

Eligibility Criteria:
Inclusion Criteria:

* All children 1-35 months of age living in 30 Village Development Committees of Sarlahi District in southern Nepal.

Exclusion Criteria:

* Parent refusal
A Retrospective Study for Nimotuzumab Plus Postoperative Adjuvant Chemotherapy for Resectable Pancreatic Cancer

This trial is a retrospective, observational study, patients who underwent surgical resection of the pancreas for non-metastatic pancreatic cancer between 2016 and 2022 were selected and divided into two groups according to with (study arm) or without (control arm) nimotuzumab. The primary efficacy endpoint was overall survival (OS).

This trial is a retrospective, observational study based on real-world data obtained from the Health Information System (HIS) of Ruijin Hospital, Shanghai Jiao Tong University School of Medicine. Patients who underwent surgical resection of the pancreas for non-metastatic pancreatic cancer between 2016 and 2022 were selected and divided into two groups according to with (study arm) or without (control arm) nimotuzumab. The primary efficacy endpoint was overall survival (OS).

Eligibility Criteria:
Inclusion Criteria:

* Age≥18 years old, gender is not limited;
* Confirmed by histopathological or cytological diagnosis of pancreatic cancer;
* Underwent surgical resection of the pancreas for non-metastatic pancreatic cancer (including resectable/borderline resectable pancreatic cancer, or locally advanced pancreatic cancer);
* Received Nimotuzumab plus adjuvant chemotherapy or adjuvant chemotherapy alone after surgery.

Exclusion Criteria:

* Patients with other primary malignancies other than pancreatic cancer;
* Evidence of recurrence or distant metastasis before surgery
* Received immunotherapy drugs (such as PD-1 inhibitors, etc.) used during adjuvant therapy, or proprietary Chinese medicines with anti-tumor indications, or hyperthermia, targeted therapy drugs other than nimotuzumab;
* Key information is missing (e.g., primary endpoint data were not available).
Sanctura Muscarinic Receptor Antagonist Resists Transport (SMART-II) Trial

This study will evaluate the cerebrospinal fluid levels of trospium chloride (Sanctura XR®) and oxybutynin immediate release (Oxybutynin IR) on memory performance in patients with overactive bladder and age associated memory impairment.


Eligibility Criteria:
Inclusion Criteria:

* Patient presents symptoms of overactive bladder
* Patient has age associated memory impairment
* No acute or unstable medical conditions

Exclusion Criteria:

* History of alcohol or substance abuse within 1 year prior to study
* Has donated in excess of 500mL of blood or plasma in the 30 days prior to study
* Has known bleeding disorder (hemophilia)
* Previous abdominal bypass surgery for obesity
Multiple Ascending Dose Study on Safety, Tolerability, and Pharmacokinetics of AMG 581 in Healthy Subjects or Subjects With Schizophrenia or Schizoaffective

The purpose of this study is to find out the time it takes to absorb, distribute, breakdown and remove the drug from the body in healthy participants and subjects with schizophrenia and whether it causes any side effects.

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetic profile of ascending multiple oral doses of AMG 581 in healthy subjects or subjects with schizophrenia or schizoaffective disorder on antipsychotic medication. The study will also assess the effects of AMG 581 on midazolam PK in healthy subjects or subjects with schizophrenia or schizoaffective disorder on antipsychotic medication.

Eligibility Criteria:
Inclusion Criteria:

- Provided informed consent prior to initiation of any study-specific activities/procedures; -male or female subjects should be between the ages of 18 and 45 years (18-55 years for subjects with schizophrenia);-non-nicotine or non-tobacco (healthy subjects only); - no history of relevant medical disorders; - BMI ≥ 18.0; - females of non-reproductive potential; - males practicing effective birth control; - avoid tanning/direct sunlight; - schizophrenia or schizoaffective disorder; PANSS score ≤ 4 points on following items (i.e. conceptual disorganization, hallucinatory behavior, excitement, suspiciousness/persecution, hostility, depression, anxiety, disorientation, uncooperativeness, disturbance of volition, and poor impulse control) / total score ≤ 80 points

Exclusion Criteria:

* females lactating/breastfeeding; pregnant partners of male subjects; essential tremor or gait disturbance; - history of hereditary shorten QT syndrome; - malignancy or tumor (other than skin cancers); - history of GI disease that could interfere with absorption; - QTc ≥ 450 msec or ≤ 380 msec; - HbA1c ≥ 7%;
Management of Coagulopathy During Orthotopic Liver Transplantation. Comparison Between ROTEM-based Management and Standard Biological Assessment.

In current practice, management of coagulation during liver transplantation is performed either through standard coagulation status or with ROTEM® depending on practitioner choice and availability of materials. In this context, the ROTEM® is used since over 2 years by anesthesiologists in the digestive surgery department of the Croix Rousse hospital in Lyon, France.

Indeed liver transplantation surgery is at high risk of bleeding due to coagulopathy developed by patients who are eligible, due to coagulation factor synthesis deficiencies in the cirrhotic liver. On the other hand the standard coagulation profile is a poor reflection of coagulopathy in such patients because the imbalance between pro- and anti-coagulant factors are not taken into account by PT and aPTT measures. Management of intraoperative hemorrhage may be facilitated by the ROTEM® which is performed from whole blood and which allows the detection of abnormalities in the balance between pro- and anti-coagulant factors.

This technique was already evaluated in liver, cardiac, and obstetric surgery but also in traumatology. Randomized trials in liver transplantation surgery have shown changes in transfusion practices but did not focus on the consequences of such changes.


Eligibility Criteria:
Inclusion Criteria:

* Patients \>=18 years of age
* Patients undergoing orthotopic liver transplantation in the Croix-Rousse Hospital within 24 months after inclusion and who have received clear information and who are not opposed to the participation in the study
* Patients affiliated to a social security system or similar
* Patients not subject to a measure of legal protection

Exclusion Criteria:

* Opposition to participation in the study
* Patients \<18 years of age
* Patients who participated in the previous month to another study protocol
* Pregnant women or breast-feeding
* Not affiliated to a social security system
* Patients with hemostasis pathology (hemophilia, ...)
NAPOLI-2: Fluorouracil, Leucovorin, and Nanoliposomal Irinotecan in Biliary Cancer

This is a study to evaluate the clinical activity of the combination of fluorouracil, leucovorin, and nanoliposomal irinotecan as second-line treatment in patients with advanced biliary tract cancers following gemcitabine and platinum chemotherapy.

This is a single arm, open label, multicenter phase II study to evaluate the clinical activity of the combination of fluorouracil, leucovorin, and nanoliposomal irinotecan as second-line treatment in patients with advanced biliary tract cancers following gemcitabine and platinum chemotherapy. Patients with advanced biliary tract cancers who have adequate performance status and adequate hepatic and renal function will be eligible. Patients may have received adjuvant chemotherapy and/or radiation therapy prior to enrolling in the trial, but a minimum of 6 months between adjuvant chemotherapy and this current therapy are required. Patients may continue on study as long as they are tolerating treatment and do not have progression of disease by RECIST v1.1 criteria. Response assessments will occur using imaging (CT or MRI) every 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically-confirmed biliary tract cancer (cholangiocarcinoma or gallbladder adenocarcinoma), unresectable or metastatic
* Disease progression on or intolerance of gemcitabine- and platinum-based chemotherapy
* No more than 1 prior line of chemotherapy for unresectable or metastatic disease (adjuvant therapy does not count)
* Measurable disease by RECIST v1.1 criteria
* ECOG performance status of 0-1
* At least 18 years of age
* HIV-positive patients are eligible provided: Stable HAART regimen, No concurrent prophylactic antibiotics or antifungals, and CD4 count above 250 and undetectable viral load
* Adequate bone marrow, hepatic, and renal function
* Consent to access archived tumor tissue if available (available tissue is not required for enrollment)

Exclusion Criteria:

* Ampullary adenocarcinoma
* Woman who are pregnant or breastfeeding
* Anti-cancer treatment within 3 weeks prior to enrollment
* Prior irinotecan or nanoliposomal irinotecan
* Central nervous system metastases unless stable for at least 4 weeks and at least 2 weeks off corticosteroids
* Exposure to a strong CYP3A4 inducer, strong CYP3A4 inhibitor, or strong UGT1A1 inhibitor within 2 weeks of study start
* Known concurrent malignancy or other malignancy within 3 years except for non-melanomatous skin cancers, prostate or cervical cancers following curative therapy, or superficial bladder cancer
* Bowel obstruction
* Allergy or hypersensitivity to fluoropyrimidines, irinotecan, or nanoliposomal irinotecan
* Clinically significant liver disease: Patients with resolved hepatitis B infection are eligible if HBsAg testing is negative; Patients with resolved hepatitis C infection are eligible if viral RNA PCR is negative
* Severe infections within 4 weeks prior to enrollment
* Major surgery within 4 weeks prior to enrollment
Fecal Microbiota Transplantation for Decompensated Cirrhosis

Imbalance of gut bacteria is suspected to play a key role driving the progression of cirrhosis and there is hope manipulation of these bacteria may be beneficial. This study will determine if fecal microbiota transplantation is an effective and safe treatment for decompensated cirrhosis.

Two groups of inpatients with decompensated cirrhosis will be randomized using random sequence generator into experimental and control groups. Two groups will given traditional treatments and experimental group will added treatment with fecal microbiota transplantation via endoscope and/or cenema.The liver function parameters, adverse events complication, systemic inflammatory markers, Intestinal mucosa structure, permeability changes in the intestinal mucosal barrier, Microbiota composition will be assessed and thereafter at 1 month and 3 months \& subjects will be clinically assessed for improvement or worsening.

Eligibility Criteria:
Inclusion Criteria:

1. \>18 years of age
2. Agreed to participate in this clinical study and signed informed consent, follow-up time greater than 3 months.
3. Comply with the diagnostic criteria of decompensated liver cirrhosis, including liver function damage, portal hypertension clinical manifestations, laboratory and imaging studies.

Exclusion Criteria:

1. Ongoing bacterial infection requiring antibiotic treatment.
2. current or history of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to screening (significant alcohol consumption is defined as more than 20 g/day in females and more than 30 g/day in males, on average).
3. consecutive months within 1 year prior to screening.
4. Treatment with antibiotics or probiotics in the preceding 3 months.
5. Inability to safely perform an GastroIntestinal endoscopy.
6. No history of recent spontaneous bacterial peritonitis or gastrointestinal bleeding.(14 days).
7. Human Immunodeficiency Virus (HIV) infection.
8. Active, serious medical disease with likely life expectancy less than 5 years.
9. Active substance abuse including inhaled or injection drugs in the year prior to screening.
10. pregnancy, planned pregnancy, potential for pregnancy and unwillingness to use effective birth control during the trial, breast feeding.
11. Any other condition which, in the opinion of the investigator, would impede compliance or hinder completion of the study.
12. History of severe (anaphylactic) food allergy.
13. History of gastroparesis or altered gastric motility -
14. Psychiatric disorder
Physical Exercise Program in Obese and Overweight Pregnant Women

Obesity and overweight have become an epidemic in the world and its prevalence between pregnant women is especially dangerous. Having a high Body Mass Index (BMI) is also associated with depression disorders and its serious complications during this period.

The aim of our study is to assess whether a specific exercise program during pregnancy has a positive effect on maternal mood and other pregnancy outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Being healthy and able to exercise following American College of Obstetricians and Gynecologists (ACOG) guidelines
* Being able to communicate in spanish
* Giving birth at Hospital Universitario de Fuenlabrada
* Having a Body Mass Index (BMI) greater than 24.9

Exclusion Criteria:

* Multiparity
* Obstetrician complications
* Being interested in the study after 18 weeks
* Not being regular in physical exercise program (minimum adherence 80%)
* Younger than 18 years old
Turkish Validity and Reliability of Physiotherapist Self-Efficacy Questionnaire

The aim of this study is to provide Turkish validation and determine the validity of the "Physiotherapist Self-Efficacy Questionnaire".

Self-efficacy is defined as one's belief in one's existing capacity to perform the necessary behavior in a specific situation. "Physiotherapist Self-Efficacy Questionnaire" has been developed to be used in the assessment of self-efficacy for the field of physiotherapy and rehabilitation. In this scale, there are 13 items about how competent the individual feels in clinical assessment, problem solving, planning, and communication related to caseloads.

It has been shown that the scale is a valid and reliable method in cardiorespiratory, musculoskeletal and neurological clinical fields, which are special areas of physiotherapy and rehabilitation.

Eligibility Criteria:
Inclusion Criteria:

* Able to speak, read, understand and write in Turkish
* Physiotherapy and rehabilitation students who have participated in at least one clinical practice
* Physiotherapists working in the clinic

Exclusion Criteria:

* Having cognitive problems
An Investigational Study to Evaluate Experimental Medication BMS-986224 in Renally Impaired Participants

The purpose of this study is to investigate the experimental medication BMS-986224 in participants with varying levels of renal function.


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* BMI ≥18 and ≤ 35kg/m2
* Systolic blood pressure \>100 mmHg

Exclusion Criteria:

* Women of childbearing potential or women who are currently pregnant
* Clinically relevant abnormal medical history, abnormal findings on physical examination, vital signs, ECG, or laboratory tests at screening that the investigator judges as likely to interfere with the objectives of the trial or the safety of the volunteer
* Current or recent (within 3 months of study treatment administration) gastrointestinal disease that could affect absorption

Other protocol defined inclusion/exclusion criteria could apply
Kinetics and Ecology of Human Papillomavirus Genital Infections in Young Women

Most genital infections by human papillomaviruses (HPV) are asymptomatic or benign and clear within a few months or years. There infections are much less studies than chronic infections, even though they represent the main reservoir for the virus. The goal of this project is to decipher the kinetics of the virus and of the host immune response in acute HPV genital infections in your women. This will be performed by following women longitudinally and regularly in order to measure variations in virus load, immune cell count, cytokine concentration and antibody titers. The investigators will also investigate the interaction between these kinetics and host genetics and host vaginal microbiota


Eligibility Criteria:
Inclusion Criteria:

* Sexually active with at least one new partner over the last 12 months
* Subjects must be able and willing to give written informed consent
* Living in the 'agglomération de Montpellier'

Exclusion Criteria:

* History of cervical pathology
* Pregnant or intending to become pregnant soon (in the coming year)
* Infected by HIV
* Undergoing (or planning to undergo) heavy treatment (biotherapy, chemotherapy, immunosuppression)
* Participation in a clinical trial involving administration of drugswithin the last 4 weeks before the screening date
COMPLI-PICC: Study on Picclines' Complications

This is a prospective monocentric study of PICC Line complications use in 5 medical and one surgical units of Brest Medical University Hospital.

To evaluate the incidence of the following complications: infections, thromboses, mechanical and hemorrhagic, at month 3 post-intervention.

Also evaluating:

* the management of these PICC Line related complications,
* risk factors for such complications,
* and the mortality-related outcomes.

All eligible patients fulfilling the inclusion criteria, after PICC Line placement, will receive oral and written patient information describing the study deployment and follow-up. Patients will be followed up until PICC Line removal if it occurs during the first 3 months after placement or until death if it occurs during the first 3 months, or during 3 months in the absence of complications.

* Infectious complications are described in accordance with IDSA 2009 guidelines and include bloodstream infection, endocarditis, local infection and septic thrombophlebitis.
* Thrombotic complications are defined as symptomatic, deep, or superficial venous thrombosis, confirmed by Ultrasound and Echo-Doppler or asymptomatic venous thrombosis diagnosed fortuitously.
* Mechanical complications are defined as impairments related to PICC Line device: occlusion, rupture, accidental removal.
* Hemorrhagic complications are defined as hematoma or bleedings of puncture site.

In the event of PICC Line-related complications, patient will be followed up for an additional 3 months, from the date of complication diagnosis, i.e. maximum follow-up duration of 6 months.

Each week during the first month, then once monthly during the follow-up (i.e. W1, W2, W3, W4, M2, M3, +/- M4, M5, M6), all patients data related to the PICC Line retention or removal, use and all its related complications will be collected.

Eligibility Criteria:
Inclusion Criteria:

* Patient \> 18 yo
* Patients \> 18 yo hospitalized in internal medicine, pneumology, nutrition, oncology, hematology, and cardiac and vascular surgery - who underwent PICC Line placement between October 10, 2016 and March 9, 2017

Exclusion Criteria:

* Patients hospitalized in other units than those cited above
* Patients verbal refusal to participate in the study
An Open-Label Study to Assess the Pharmacokinetics and Safety of HALAVEN in Subjects With Cancer Who Also Have Impaired Renal Function

This is an open-label non-randomized study in subjects with advanced or metastatic solid tumors who are no longer responding to available therapy. HALAVEN will be administered to subjects on Days 1 and 8 of a 21-day cycle.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed advanced solid tumors that have progressed following standard therapy or for which no standard therapy exists (including surgery or radiation therapy).
* Renal function must fall into one of the following categories:
* Normal function - creatinine clearance greater than or equal to 80 mL/min.
* Moderate impairment - creatinine clearance \>30 to 50 mL/min.
* Severe impairment - creatinine clearance 15 to less than 30 mL/min.
* Adequate liver function as evidenced by bilirubin less than or equal to 1.5 times the upper limit of normal (ULN) and alkaline phosphatase (ALP), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) less than or equal to 3 times the ULN (in the case of liver metastasis less than or equal to 5 times ULN). In the case ALP \>3 times the ULN (in the absence of liver metastasis) or \>5 times the ULN (in the presence of liver metastasis), and the subject is also known to have bone metastasis, the liver specific ALP must be separated from the total and used to assess the liver function instead of the total ALP.

Exclusion Criteria:

* Subjects with mild renal impairment (creatinine clearance greater than 50 to less than 80 mL/min).
* Subjects with end stage renal disease (creatinine clearance less than 15 mL/min or on dialysis).
* Subjects with a hypersensitivity to halichondrin B and/or halichondrin B chemical derivatives.
* Subjects with prior participation in an HALAVEN clinical study, even if not previously assigned to HALAVEN treatment.
* Radiation therapy encompassing \>30 % of bone marrow.
* Subjects with organ allografts requiring immunosuppression.