louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01322477: Contribution of F-18 Fluoro-Deoxy-Glucose PET/CT (Positron Emission Tomography) to the Assessment of HCC (Hepato-cellular Carcinoma) Treatment Efficiency
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatocellular Carcinoma
Keywords: Identification of treatment efficacy in patients with advanced HCC by PET/CT F18-FDG
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2011-03-24
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Advanced HCC

Brief summary: HCC (Hepato-cellular Carcinoma) is the fifth most frequent cancer in humans and its prevalence is growing. The most effective treatment of HCC is surgical and includes resection and liver transplantation; however, only 20% of the patients can be treated surgically. Local interventional therapy, such as radiofrequency (RF) ablation and transarterial embolization is also used.

Recurrence rate is very high, and extrahepatic disease develops in about 30% of the cases and in up to 20% after liver transplantation.

Systemic treatment is thus an option. Sorafenib (multi-kinase inhibitor) is the first agent to significantly improve the overall survival in advanced HCC. However, the drug has serious side effects and is very expensive.

PET/CT with F18-FDG is a common tool for systemic evaluation and staging of various tumors.

The value of the FDG PET for evaluation of HCC is controversial, in particular due to the unique metabolic pathway of glucose in the HCC cells. Since 2007 more and more studies suggest the feasibility of FDG PET/CT for monitoring local recurrence (especially after RF) and metastatic spread of HCC, including detection of active disease only suspected by AFP (alphafoetoprotein) elevation.

Early detection of treatment response to therapy by whole body FDG PET/CT allows for change of treatment as early as possible,when the tumor is non-responsive before serious side effects appear or before depletion of body resources.

The aim of our study is to investigate the contribution of FDG PET/CT to assessment of treatment response.


Eligibility criteria: Inclusion Criteria:

* advanced HCC for systemic treatment

Exclusion Criteria:

* HCC only localized in liver,
* Other liver disease (e.g. metastases and benign lesions)

Primary outcomes:
measure: Measure of extent and intensity (standardized uptake value - SUV) of disease demonstrated on PET/CT images before and after treatment.
timeFrame: 12 weeks: PET/CT performed before treatment and every 4 weeks, after end of each treatment twice
Secondary outcomes:
measure: Prediction of treatment efficiency
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Hebrew University Medical Center
Study officials:
References:
Clinical trial NCT05455853: Effect of Bilateral Transcutaneous Tibial Nerve Stimulation on Postpartum Constipation
Official title: Effect of Bilateral Transcutaneous Tibial Nerve Stimulation on Postpartum Constipation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Constipation
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-07-13
Enrollment: 60
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will be conduct to determine the effect of bilateral transcutaneous tibial nerve stimulation on treating postpartum constipation

Detailed description: TTNS was effective in treating constipation .It was believed that re-establishment of normal colonic function may be possible with neuromodulation of sacral nerve stimulation (SNS) that may improve constipation symptoms but it is expensive and invasive . Percutaneous tibial nerve stimulation (PTNS) is an alternative method of neuromodulation that has shown efficacy in constipation and it stimulates L4-S3 nerve roots of sacral plexus that supply the pelvic floor and lower gastrointestinal tract, Transcutaneous tibial nerve stimulation (TTNS) targets the tibial nerve in a similar fashion to PTNS but it is cheaper and does not require needle puncture .There were few studies showed that TTNS has been used and shown to be effective for treating constipation, but till now, there is no previous study illustrating it's effect specifically on postpartum constipation. So, this study will be the first one in this issue.

Eligibility criteria: Inclusion Criteria:•Postpartum women, delivered by caesarean section suffering from constipation after delivery.

* Their ages will range from 20 to 35 years old.
* Their body mass index (BMI) will range from 25 to 33 kg/m2.
* All participating women should have at least two criteria of Rome III diagnostic criteria for constipation.

They should stop laxatives intake during treatment program

-

Exclusion Criteria:

Postpartum women will be excluded if they have:

* History of inflammatory bowel disease, and irritable bowel syndrome.
* Endocrine disease or digestive tract disease.
* History of genital prolapse and anal fissure.
* Congental anorectal malformation, stoma in situ.
* Diabtes mellitus and sever distal venous insuffiency.
* Skin eruption at the site of stimulation.
* Implanted pacemaker or defibrillator.
* Metalic implant in lower limb.
* Recent surgery at the lower limb.
* Peripheral neuropathy and neurological disorders. Psychological distress.

Primary outcomes:
measure: The Bristol Stool Form Scale (BSFS)
timeFrame: up to 4 weeks
measure: Patient Assessment of Constipation -Symptom Questionnaire (PAC-SYM)
timeFrame: up to 4 weeks
measure: Patient Assessment of constipation quality of life questionnaire (PAC-QOL)
timeFrame: up to 4 weeks
measure: Rome III criteria: Rome III criteria: Rome III criteria
timeFrame: up to 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01394653: A Study to Compare Oral Absorption of YM060 Between Orally-disintegrating Tablet and Conventional Tablet Under With Water Intake
Official title: Bioequivalence Study of YM060 Orally-disintegrating Tablet and Conventional Tablet - Ingestion With Water -
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Plasma Concentration of YM060
Keywords: YM060
ramosetron
orally-disintegrating tablet
OD tablet
bioequivalence
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2011-07-14
Enrollment: 36
Sex: MALE
Minimum age (years): 20
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: A study to compare time-course changes of plasma concentration of YM060 orally-disintegrating tablet with those of conventional tablet. Tablets will be administered with water.


Eligibility criteria: Inclusion Criteria:

* healthy assessed by the principal investigator or sub-investigators
* non-smoking or stop smoking at least 90 days before the study
* body weight: over 50.0kg and less than 80.0kg
* body mass index (BMI): over 17.6 and less than 26.4

Exclusion Criteria:

* participated in another clinical trial (including a post-marketing clinical study) within 120 days before the study
* donated 400mL of whole blood within 90 days, 200mL of whole blood within 30 days or blood components within 14 days before the study
* received any drugs within 7 days before the study or going to receive any drugs
* deviance from normal range in vital signs (blood pressure, pulse rate, and body temperature) or 12-lead ECG
* deviance from normal range in lab-tests
* history of drug allergy
* history or current diagnosis of stomach, small intestine or large intestine diseases
* history or current diagnosis of inflammatory bowel disease (Crohn's disease or colitis ulcerative)
* history or current diagnosis of colitis ischemic
* history or current diagnosis of hepatic diseases
* history or current diagnosis of cardiovascular diseases
* history or current diagnosis of respiratory diseases
* history or current diagnosis of malignant tumor
* received ramosetron tablet

Primary outcomes:
measure: Area under the curve of YM060 plasma concentration -time curve
timeFrame: up to 24 hours after administration
measure: Maximal concentration of YM060 plasma concentration
timeFrame: up to 24 hours after administration
Secondary outcomes:
measure: Safety assessed by the incidence of adverse events, vital signs, lab-tests and 12-lead ECG
timeFrame: up to 24 hours after administration
Other outcomes:
Locations:
city: Tokyo
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Use Central Contact
role: STUDY_CHAIR
References:
Clinical trial NCT06420453: How Long Can Labor Last? Person Centred Care During Labor to Increase Safety for Women and Newborn
Official title: How Long Can Labor Last? Person Centred Care During Labor to Increase Safety for Women and Newborn
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Birth Outcome, Adverse
Labor Long
Labor Complication
Maternal Injury
Maternal Distress During Labor and Delivery
Neonatal and Perinatal Conditions
Labor Duration
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: The Swedish Research Council
First posted: 2024-05-20
Enrollment: 300000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This is an epidemiological research project using the largest cohort in the world containing detailed information on labor progression and care during labor. The cohort used is built from detailed data from medical records in the Stockholm-Gotland Obstetric Cohort, including all births from 2008 to 2020 (\> 300 000 births). This includes data from the partograph with information about start of labor, all cervical examinations, care interventions, total duration of labor, maternal and neonatal outcomes. For completeness of data on infant outcomes, the cohort has been linked with the Swedish Neonatal Quality Register (SNQ).

Brief summary: "How long will my labor last" is a very common question for midwives who care for women during birth. To evaluate safe labor duration largely determines management and care during birth. Today a standardized tool is used by midwives to evaluate normal and safe labor called the partograph. The World Health Organization partograph is a decision-making support tool designed to assist midwives in identifying normal labor duration and women at risk of developing complications. The tool guide the use of care interventions intended to mitigate any perceived risks. The partograph has been in use since the 1950ies and has had a profound impact on care and management during labor. Normal labor progression according to the partograph is a linear progression with cervical dilation of 1 centimeter per hour (alert line) and any deviation from this should lead to an intervention.The purpose of this research project is to increase person-centred care during labor. Specifically, we want to provide updated comprehensive information on labor duration and patient safety for reduction of; unnecessary medical interventions during normal labor; morbidity and mortality in the new-born; maternal complications during delivery and the puerperal period.


Eligibility criteria: Inclusion Criteria:

All births with labor duration

Exclusion Criteria:

Elective Cesarean birth

Primary outcomes:
measure: Adverse neonatal outcomes
timeFrame: 1 month postpartum
measure: Adverse maternal outcomes
timeFrame: 1 month postpartum
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet
Study officials:
References:
Clinical trial NCT02727153: "Ultra" Enhanced Recovery After Surgery (E.R.A.S.) in Laparoscopic Colectomy for Cancer
Official title: "Ultra" Enhanced Recovery After Surgery (E.R.A.S.) in Laparoscopic Colectomy for Cancer: Discharge After the First Flatus? A Prospective, Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colonic Cancer
Keywords: Colonic cancer
E.R.A.S. programs
Safety
Lead sponsor: AUSL Romagna Rimini
Sponsor class: OTHER
First posted: 2016-04-04
Enrollment: 765
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background. Enhanced Recovery After Surgery (E.R.A.S.) programs are now widely accepted in colonic laparoscopic resections because of faster recovery and less perioperative complications.

Objective. Aim of this study is to assess safety and feasibility of discharging patients operated on by laparoscopic colectomy on Post Operative Day 2 (POD 2), so long as the first flatus has passed and in the absence of complication-related symptoms.

Design \& Settings. Non-inferiority, open-label, single center, prospective, randomized study comparing "Ultra" to Classic E.R.A.S. with discharge on POD 2 and 4 respectively.

Patients. 765 patients with resectable non metastatic colonic cancer were analyzed: 384 patients were assigned to "Ultra" E.R.A.S. and 381 to Classic E.R.A.S.

Main Outcome Measures. Demographics, clinico-pathological, ASA class and morbi-mortality, along with surgical complications, re-operation and readmission rate were recorded and compared. Primary end-point was mortality; secondary end-points were morbidity, re-admission and re-operation rate.

Limitations. It is a single center experience; it is not double-blind, with the intrinsic risk of intentional or unconscious bias; exclusion criteria because of "non compliance" may be considered arbitrary.

Detailed description: From January 2008 to September 2015, 765 patients were prospectively randomized for early discharge after laparoscopic colectomy according to E.R.A.S. programs: after obtained informed consent, 384 patients were randomly assigned to the "Ultra" E.R.A.S. group and 381 to Classic E.R.A.S. group.

Eligibility criteria: Inclusion Criteria:

* Resectable colonic cancer

Exclusion Criteria:

* metastatic patients
* T4b tumors
* urgent operations (because of obstruction, perforation or bleeding refractory to conservative treatment)
* huge neoplasms (\>7cm)
* positive cytology in peritoneal lavage or frank carcinosis
* inability to tolerate pneumoperitoneum
* ASA class 4
* severe portal hypertension with hepato-caval gradient \>10mmHg

Primary outcomes:
measure: Mortality
timeFrame: 90 days
Secondary outcomes:
measure: Morbidity
timeFrame: 90 days
measure: Reoperation rate
timeFrame: 90 days
measure: Readmission rate
timeFrame: 90 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00248053: Use of Curcumin in the Lower Gastrointestinal Tract in Familial Adenomatous Polyposis Patients
Official title: Use of Curcumin in the Lower Gastrointestinal Tract in Familial Adenomatous Polyposis (FAP) Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Familial Adenomatous Polyposis
Keywords: Familial adenomatous polyposis patient with 5 or more adenomatous polyps in the colon or ileoanal pouch
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2005-11-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this study is to assess if curcumin, a commonly used food spice, can regress colorectal adenomatous polyps in patients with familial adenomatous polyposis, an inherited form of colorectal cancer.


Eligibility criteria: Inclusion Criteria:

* Familial adenomatous polyposis
* 18 years of age or older
* 5 or more adenomas of colorectum or ileum

Exclusion Criteria:

* Female patient of child bearing age not on effective birth control pills
* Pregnant women
* White blood cell (WBC) count less than 4000
* Platelets (Plts) less than 100,000
* Blood urea nitrogen (BUN) greater than 25
* Creatine greater than 1.5
* Patients unable to stop non-steroidal anti-inflammatory drugs (NSAIDs) during duration of trial
* Malignancy
* Patient with active bacterial infections of gastroesophageal reflux disease or peptic ulcer disease
* Patient on warfarin or anti-platelet drugs

Primary outcomes:
measure: polyp number and size
timeFrame: one year
Secondary outcomes:
measure: side effects and medication compliance
timeFrame: one year
Other outcomes:
Locations:
Study officials:
affiliation: Johns Hopkins University
name: Francis M Giardiello, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00238953: Efficacy and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS) in de Novo Kidney Transplant Recipients
Official title: A Prospective, Open Label Protocol to Assess the Efficacy and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS) in de Novo Kidney Transplant Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Renal Transplantation
Keywords: Kidney transplantation
enteric-coated mycophenolate sodium
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-10-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Clinical trial for the novo transplant recipients, which aims to assess tolerability and safety and clinical outcomes of EC-MPS in combination with cyclosporine microemulsion (CsA-ME) with or without steroids in a population of kidney transplant recipients.


Eligibility criteria: Inclusion criteria:

* Male and females aged 18 to 75
* Recipients of cadaveric, living unrelated or living related kidney transplant, treated with CsA-ME, with or without corticosteroids, as primary immunosuppression

Exclusion criteria:

* Multi-organ recipients (e.g. kidney and pancreas) or previous transplant with any organ, other than kidney.
* Patients with any known hypersensitivity to MPA, EC-MPS or other components of the formulation (e.g. lactose).
* Patients with thrombocytopenia (\< 75,000/mm3), with an absolute neutrophil count of \< 1,500/mm3, and/or leukocytopenia (\< 2,500/mm3), and/or hemoglobin \< 6 g/dL at Screening or Baseline.

Other inclusion/exclusion criteria may apply

Primary outcomes:
measure: 6 Month evaluation
measure: patient and graft survival
measure: acute rejection (suspected or biopsy confirmed)
measure: graft function (serum creatinine, calculated creatinine clearance and glomerular filtration rate),
measure: infections, adverse events, serious adverse events.
Secondary outcomes:
measure: Influence of parameters: demography, medical conditions, complications post transplantation on main clinical outcomes. 6 month evaluation
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Novartis
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_DIRECTOR
References:
citation: Wyzgal J, Niemczyk M, Ziolkowski J, Durlik M, Wiecek A. Results of a 6-month, multicenter, open-label, prospective study concerning efficacy and safety of mycophenolate sodium in de novo kidney transplant recipients. Transplant Proc. 2007 Nov;39(9):2730-2. doi: 10.1016/j.transproceed.2007.08.071.
Clinical trial NCT02139553: Effect of Rhythmic Upper-limb Training in Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Stroke
Keywords: Rhythmic versus discrete movements
Rehabilitation
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2014-05-15
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether rhythmic upper-limb movement training in post-stroke patients allows to improve only this particular type of movements or if it also improves some parameters of discrete movements. Based on our results we hope to be able to answer a fundamental question: are rhythmic and discrete movements two independent primitives?

Detailed description: Patients are assessed four times during this longitudinal study. One month separates the first two assessment, next patients are trained 12 times during one month with rhythmic movement training on an end-effector robot. After this month, patients are assessed a third time and three months later a fourth time in order to study long-time benefits of the therapy.

Eligibility criteria: Inclusion Criteria:

* more than 6 months post-stroke patients
* Fugl-Meyer between 7 and 55
* Maintain the same intensity of rehabilitation during the study

Exclusion Criteria:

* cerebellar stroke
* severe aphasia or cognitive disorder
* any other neurological disorder

Primary outcomes:
measure: Change in movement smoothness in rhythmic straight movements after one month of rhythmic therapy
timeFrame: 1 week to 1 day before therapy and 1 day to 1 week after therapy
measure: Change in movement smoothness in discrete straight movements after one month of rhythmic therapy
timeFrame: 1 week to 1 day before therapy and 1 day to 1 week after therapy
measure: Change in accuracy of discrete straight movements after one month of rhythmic therapy
timeFrame: 1 week to 1 day before therapy and 1 day to 1 week after therapy
measure: Change in smoothness of rhythmic circular movement after rhythmic therapy
timeFrame: 1 day to 1 week before therapy and 1day to 1 week after therapy
Secondary outcomes:
measure: Change of the general motricity of the patient due to one month rhythmic therapy
timeFrame: 1 week to 1 day before therapy and 1 day to 1 week after therapy
measure: Therapy after effects
timeFrame: 1 day to one week after therapy and 3 months after therapy
measure: Assessment of the natural evolution of the patient
timeFrame: 4 to 5 weeks before therapy and 1 week to 1 day before therapy
Other outcomes:
Locations:
city: Woluwe-St-Lambert
country: Belgium
facility: Cliniques universitaires Saint-Luc
state: Brabant Wallon
Study officials:
References: