louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02101957: Multicentric Trial of the Treatment of Huntington's Disease by Cysteamine (RP103)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Huntington's Disease
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2014-04-02
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effect of cysteamine in patients with symptomatic Huntington's disease by comparing two groups of patients (cysteamine vs placebo) on the results of the Unified Huntington's Disease Rating Scale (UHDRS, Huntington study group 1996).


Eligibility criteria: Inclusion Criteria:

* Clinically disease-registered for at least one year, leading to consult (abnormal movements, neuropsychiatric disorders, neuropsychological impairment).
* Unified Huntington's Disease Rating Scale motor ≥ 5
* Total Functional Capacity \> 10 (≥ 11)
* Huntington Disease diagnosed with abnormal number of CAG repeats: 38 \< nucleotide expansion (CAG)
* Age between 18 and 65
* Voluntarily Patient Consent
* Patients willing and able to take oral medications, and comply with the specific procedures of the study

Exclusion Criteria:

* Severe cognitive impairment or neuropsychiatric troubles.
* No drug compliance to previous treatment.
* Patients with contra indication to the realization of imaging studies (including claustrophobia ) .
* Patients who have not given their written and informed consent signed .
* No national health insurance affiliation
* Private patients of their liberty by judicial or administrative decision, or patients under supervision.
* Pregnant women ( pregnancy test will be carried out systematically for women at risk) or lactating .
* Women who could become pregnant during the study period and with no contraception.
* Patients who have developed hypersensitivity to cysteamine or penicillamine ( against indication of cysteamine ) .
* Brain Damage intercurrent MRI. Brain morphological abnormalities , other than those characteristic of the disease .
* Disease - associated with neurological repercussions.
* Affection - visceral serious , scalable , involving life-threatening.
* Mental - disorder may disrupt accession to the Protocol , including a history of spontaneous and / or drug-induced hallucinations history of severe depression that required repeated hospitalizations , history of repeated suicide attempts .
* Participation in progress, or interrupted for less than three months, a therapeutic protocol of Huntington's disease .
* Patients with a history of surgical interventions to improve the symptoms of Huntington 's disease such as graft neuron, deep brain stimulation, infusion of neurotrophic agent

Primary outcomes:
measure: Unified Huntington's Disease Rating Scale motor
timeFrame: at 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers
Study officials:
References:
Clinical trial NCT00876057: Psychological Well-being, Recovery and Sexuality After Total and Subtotal Hysterectomy
Official title: Subtotal Versus Total Abdominal Hysterectomy- a Prospective Randomised Comparison of Medical , Psychological and Sexual Effects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hysterectomy
Keywords: psychological well-being
recovery
time in hospital
sick-leave
complications
Sexual well-being
Lead sponsor: University Hospital, Linkoeping
Sponsor class: OTHER
First posted: 2009-04-06
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether psychological well-being, recovery and sexuality differs in women undergoing subtotal and total abdominal hysterectomy.

Se also Detailed Description for additional study.

Detailed description: An additional study study based on the material in original study started in april 2011. The purpose of this study is to investigate the development of pelvis organ prolapse in the long term (median eleven years after hysterectomy and by questionnaires, Pelvic-floor Distress Inventory SF-20 analyze if patient reported symptoms regarding urinary-and bowels functions differs regarding the method of hysterectomy.

Eligibility criteria: Inclusion Criteria:

* Primarily uterine fibroids with bleeding disturbance or mechanical symptoms but other benign disorders were hysterectomy was recommended were also eligible
* After surgery at least one ovary preserved.
* Informed verbal and written consent
* Proficiency in Swedish

Exclusion Criteria:

* Malignancy in the genital organs.
* Previous or present cervical dysplasia.
* Rapidly growing fibroids where malignancy could not be ruled out
* Preoperative treatment with GnRH analogues.
* Postmenopausal women without hormone therapy
* Severe psychiatric disorder

Primary outcomes:
measure: Psychological well-being
timeFrame: One year after surgery
Secondary outcomes:
measure: Recovery of general well-being
timeFrame: Five weeks after surgery
measure: Sexuality
timeFrame: One year
measure: Pelvic organ prolapse (anatomical)
timeFrame: 7-14 years
measure: Patient reported symptoms of pelvic organ dysfunction
timeFrame: 7-14 years
Other outcomes:
Locations:
city: Eksjö
country: Sweden
facility: Höglandssjukhuset i Eksjö
city: Jönköping
country: Sweden
facility: Ryhov Central Hospital
city: Kalmar
country: Sweden
facility: County Hospital in Kalmar
city: Motala
country: Sweden
facility: Motala Counbty Hospital
city: Norrköping
country: Sweden
facility: Vrinnevi Hospital
city: Värnamo
country: Sweden
facility: Värnamo County Hospital
city: Örebro
country: Sweden
facility: Capio Läkargruppen
Study officials:
affiliation: University Hospital, Linköping
name: Preben Kjölhede, MD, PhD
role: STUDY_CHAIR
affiliation: University Hospital, Linköping
name: Pär Persson, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01974466: Fluid Resuscitation Goal in Early Stage of Severe Acute Pancreatitis
Official title: Fluid Resuscitation Goal in Early Stage of Severe Acute Pancreatitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pancreatitis
Keywords: pancreatitis
resuscitation goal
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
Collaborators: name: RenJi Hospital
First posted: 2013-11-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To compare different goals of fluid resuscitation in early stage of acute pancreatitis

Detailed description: With regard to study of sepsis and several studies of SAP demonstrating the deleterious effects of fluid loss and haemoconcentration within the first 24h after admission（or onset of abdominal pain）, early goal-directed fluid resuscitation has the potential of improving outcome also in SAP. But the goal of fluid resuscitation remained controversial.Several criteria of fluid resuscitation had been described. Ours had been described in previous study, and had shown a ideal result with less incidence of abdominal compartment syndrome and higher survival rate. This study aims to determine a better goal of fluid resuscitation in severe acute pancreatitis.

Eligibility criteria: Inclusion Criteria:

* 1. Diagnosis of pancreatitis: Typical pain increase in serum lipase or amylase 2. Onset of abdominal pain within \<=72h before admission 3. moderate severe or severe acute pancreatitis according to Atlanta criteria revisited in 2012 4. Evidence of \>= 1 predictor of fluid resuscitation: Haematocrit \>44% (male) or \>40% (female), respectively Lactate\>4mmol/L; heart rate\>120bpm; urine \<0.5ml/kg/h for 6 hour; Mean arterial pressure\>85 or \<60 mmHg

Exclusion Criteria:

* 1. Pregnancy 2. New York Heart Association classification \>II 3. With pacemaker implantation 4. chronic obstructive pulmonary disease 5. chronic kidney disease 6. Pre-existing disease with life expectancy \< 3 months

Primary outcomes:
measure: Mortality
timeFrame: 28day
Secondary outcomes:
measure: intra-abdominal Hypertension
timeFrame: 7 days
Other outcomes:
measure: respiratory failure
timeFrame: 14days
Locations:
city: Shanghai
country: China
facility: Ruijin
state: Shanghai
Study officials:
affiliation: Emergency intensive care unit of Ruijin Hospital
name: Qiang En Mao, PhD
role: STUDY_DIRECTOR
affiliation: doctor
name: Ming zhong, MD
role: STUDY_CHAIR
References:
citation: Mao EQ, Tang YQ, Fei J, Qin S, Wu J, Li L, Min D, Zhang SD. Fluid therapy for severe acute pancreatitis in acute response stage. Chin Med J (Engl). 2009 Jan 20;122(2):169-73.
Clinical trial NCT01438866: Use of Fissure Sealants on Primary Molars
Official title: The Effectiveness of Sealants in Prevention of Occlusal Caries on Primary Molars
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dental Caries
Keywords: Dental caries
Fissure sealant
Fluoride varnish
Primary molar
Lead sponsor: Kuwait University
Sponsor class: OTHER
First posted: 2011-09-22
Enrollment: 148
Sex: ALL
Minimum age (years): 42
Maximum age (years): 52
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Sealants have been shown to be the most effective caries preventive measure in permanent dentition. Sealants of the primary molars soon after they erupt would reduce the total caries experience of the primary teeth of the children and could possibly also postpone the caries process in the permanent dentition.

The aim of this study is to measure the caries preventive effect of sealants in primary molars. The specific objectives are: 1) to compare the number of new caries experience teeth and surfaces among the intervention group of 4-years old pre-school children during the 1 year follow-up period, 2) to compare the preventive effect of sealants with fluoride varnish on the caries experience on the occlusal surfaces of the primary molars and on the total caries experience of all the primary and permanent teeth, 3) to test the feasibility of the sealant program in one kindergarten in Kuwait city.


Eligibility criteria: Inclusion Criteria:

* positive written informed consent received from parents

Exclusion Criteria:

* if caries lesions in primary molars are so extensive that restorative treatment is needed

Primary outcomes:
measure: Number of healthy occlusal tooth surfaces of primary molars
timeFrame: up to 1 year
Secondary outcomes:
measure: Number of healthy occlusal tooth surfaces after application of fissure sealants versus fluoride varnish
timeFrame: up to 1 year
Other outcomes:
Locations:
city: Kuwait
country: Kuwait
facility: Kindergarten
state: Hawally
Study officials:
affiliation: Faculty of Dentistry, Kuwait University
name: Sisko L Honkala, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03201666: Comparison of Karyotyping, CMA and NIPT for Prenatal Diagnosing Chromosomal Anomalies
Official title: Comparison of Karyotyping, CMA and NIPT for Prenatal Diagnosing Chromosomal Anomalies
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prenatal Diagnosis
Keywords: prenatal diagnosis
non-invasive prenatal tests
chromosome microarray analysis
Lead sponsor: Taizhou Hospital
Sponsor class: OTHER
First posted: 2017-06-28
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: pregnant women who needed amniocenteses were recruited during the study period

Brief summary: This diagnostic test is aimed to compare the Karyotyping, CMA and NIPT for prenatal diagnosing chromosomal anomalies. Pregnant women who needed prenatal genetic diagnosis meted the study criterion; fetal amniotic fluid was regular examined by Karyotyping and CMA, and maternal peripheral blood was collected for NIPT detecting. And the CMA result as a golden standard, the main outcome is compared the diagnostic efficacy of NIPT for diagnosing chromosomal anomalies.

Detailed description: Aim: to compare the Karyotyping, CMA and NIPT for prenatal diagnosing chromosomal anomalies.

Design: diagnostic test Set: Prenatal diagnosis center of Taizhou City Study population: The Pregnant women who needed amniocenteses for prenatal genetic diagnosis were recruited.

Methods: amniotic fluid was regular examined by Karyotyping and CMA, and maternal peripheral blood was used for collected for NIPT detecting.

Statistic: CMA result as a golden standard, the main outcome is compared the diagnostic efficacy of NIPT for diagnosing chromosomal anomalies.

Eligibility criteria: Inclusion Criteria:

1. pregnant women who needed amniocenteses were recruited during the study period, include high risk for serum screening, aged over 35 years and ultrasound abnormal.
2. only singleton were included

Exclusion Criteria:

1. women who met the contraindication for invasive procedure as : threaten abortion, acute infectious disease.
2. Women who unfitted for NIPT analysis include multiple, history of allogeneic blood cell transfusion.

Primary outcomes:
measure: accuracy of NIPT for prenatal diagnosing chromosomal anomalies
timeFrame: July,2016-July, 2017
Secondary outcomes:
Other outcomes:
Locations:
city: Taizhou
country: China
facility: Taizhou Hospital of Zhejiang province
state: Zhejiang
Study officials:
affiliation: prenatal doagnosis center of taizhou city
name: YiYang Zhu, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01839266: Prognostic Factors for Acute Pulmonary Embolism in Critically Ill Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Pulmonary Embolism (PE)
Keywords: acute PTE, prognostic factors
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2013-04-24
Enrollment: 200
Sex: ALL
Minimum age (years): 34
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with acute pulmonary embolism(PE) (diagnosed by CT) treated in the hospital with IV unfractionated heparin

Brief summary: Acute pulmonary embolism (PE) is an important cause of in-hospital mortality and may be rapidly fatal if not diagnosed and treated. Despite recent advances in diagnostic and therapeutic modalities, it is still one of the important causes of hospital mortality. Previous several reports have described the variable outcome of patients with PE with reported mortality rate ranging from 8.1% (stable patients) to 25% (with cardiogenic shock) and 65% (post cardiopulmonary resuscitation). Nevertheless, there are no published studies from Korean hospitals that assessed the outcome of acute PE treated in the hospital with IV unfractionated heparin. We conducted this study to determine the outcome, risk factors, clinical characteristics and demographics of patients with acute PE and to identify possible demographic and clinical factors associated with prognosis.


Eligibility criteria: Inclusion Criteria:

patients admitted to the Severance Hospital, Yonsei University Health System with primary diagnosis of PE between January 2008 and December 2012. (diagnosed by CT and treated in the hospital with IV unfractionated heparin)

Exclusion Criteria:

1. diagnosis was prior to arrivalor
2. anticoagulation was contraindicated
3. diagnosis was not confirmed by CT

Primary outcomes:
measure: prognostic factors of overall survival
timeFrame: change of acute pulmonary embolism(PE) for duration of hospital stay an expected average of 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine, Chief of ICUs, Severance Hospital, Yonsei University Health System
Study officials:
References:
Clinical trial NCT01584466: Long Acting Paliperidone in Dually Diagnosed People With Schizophrenia: An Open-label Pilot Study
Official title: Long Acting Paliperidone in Dually Diagnosed People With Schizophrenia: An Open-label Pilot Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Schizophrenia
Keywords: Schizophrenia
Substance Abuse
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2012-04-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Comorbid substance abuse leads to many deleterious effects such as medical comorbidities and nonadherence, which is one of the most problematic issues. People with schizophrenia and substance use disorders (SUDs) are at an increased risk nonadherence compared to those who do not use alcohol and illicit drugs. The investigators propose that this new marketed injectable antipsychotic with many benefits over other available long acting injectable agents would be beneficial in the dually diagnosed population and may represent a specific schizophrenia subpopulation where long acting agents may be considered an important therapeutic option.


Eligibility criteria: Inclusion Criteria:

* Be between ages 18 and 64
* Either gender
* Any race
* Meet DSM-IV-TR criteria for Schizophrenia or Schizoaffective Disorder.
* Alcohol and/or cannabis use defined as a DSM-IV diagnosis abuse, dependence or regular use defined as 3 times per week during the past year
* Agree to take or use birth control during the study.

Exclusion Criteria:

* Previous lack of response or serious adverse event to risperidone or paliperidone.
* Currently on a long acting injectable antipsychotic.
* A score of less than 10 on the Evaluation to Sign Consent (ESC).
* Medical illnesses, which may compromise safe study participation.
* Pregnant and lactating females.
* QTc interval \> 450 milliseconds males or \> 470 milliseconds in females
* Currently on acamprosate, naltrexone and disulfiram.

Primary outcomes:
measure: Long acting paliperidone palmitate will improve psychotic, negative and depressive symptoms from baseline to endpoint
timeFrame: 7 months
Secondary outcomes:
Other outcomes:
Locations:
city: Catonsville
country: United States
facility: Maryland Psychiatric Research Center
state: Maryland
Study officials:
References:
Clinical trial NCT00207766: A Study of the Safety and Efficacy of Infliximab (Remicade) in Subjects With Fistulizing Crohn's Disease
Official title: ACCENT II - A Randomized, Double-blind, Placebo-controlled Trial of Anti-TNF Chimeric Monoclonal Antibody (Infliximab, Remicade) in the Long Term Treatment of Patients With Fistulizing CROHN'S Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Crohn Disease
Keywords: Crohn's Disease
infusions
Lead sponsor: Centocor, Inc.
Sponsor class: INDUSTRY
First posted: 2005-09-21
Enrollment: 306
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A study of infliximab in patients with Fistulizing Crohn's Disease

Detailed description: This is a medical research study for patients with Crohn's disease who have one or more draining enterocutaneous fistula (fistula from the bowel to the skin). Fistulas are a common complication of Crohn's disease. Fistulas rarely close spontaneously but they may get better with treatment of the underlying Crohn's disease. This study will investigate the safety and efficacy of maintenance dosing of an anti-TNF (anti-tumor necrosis factor) antibody (a protein), called infliximab, compared to a placebo (inactive substance) in providing sustained reductions in the number of draining fistulas.

Subjects will receive infliximab at weeks 0, 2 and 6 followed by infusions of infliximab 5 mg/kg or placebo at weeks 14 and every 8 weeks until week 46. Patients who lose response are eligible for increasing treatment by 5 mg/kg of infliximab.

Eligibility criteria: Inclusion Criteria:

* Single or multiple draining fistulas
* Crohn's disease of at least 3 months' duration,

Exclusion Criteria:

* Crohn's disease complications for which surgery might be indicated
* Positive stool culture

Primary outcomes:
measure: Reduction in the number of draining fistulas
Secondary outcomes:
measure: Complete fistula response (no draining fistula).
Other outcomes:
Locations:
Study officials:
affiliation: Centocor, Inc.
name: Centocor, Inc. Clinical Trial
role: STUDY_DIRECTOR
References:
citation: Sands BE, Blank MA, Patel K, van Deventer SJ; ACCENT II Study. Long-term treatment of rectovaginal fistulas in Crohn's disease: response to infliximab in the ACCENT II Study. Clin Gastroenterol Hepatol. 2004 Oct;2(10):912-20. doi: 10.1016/s1542-3565(04)00414-8.
citation: Sands BE, Anderson FH, Bernstein CN, Chey WY, Feagan BG, Fedorak RN, Kamm MA, Korzenik JR, Lashner BA, Onken JE, Rachmilewitz D, Rutgeerts P, Wild G, Wolf DC, Marsters PA, Travers SB, Blank MA, van Deventer SJ. Infliximab maintenance therapy for fistulizing Crohn's disease. N Engl J Med. 2004 Feb 26;350(9):876-85. doi: 10.1056/NEJMoa030815.
Clinical trial NCT02008266: Study of the Treatment of Algerian Patients With Early Rheumatoid Arthritis
Official title: Case Study of the Treatment of Early Rheumatoid Arthritis in Algerian Patients in Both the Private and Public Healthcare Sectors.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2013-12-11
Enrollment: 532
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Rheumatoid Arthritis that has been progressing for \> 3 months and \< 2 years.

Brief summary: This non-interventional, descriptive, cross-sectional and multicenter study will examine the treatment of rheumatoid arthritis progressing for less than two years in the Algerian population. Current drug therapy as well as disease status and patient function will be assessed.


Eligibility criteria: Inclusion Criteria:

* Rheumatoid arthritis progressing for \< 2 years.

Exclusion Criteria:

* Rheumatoid arthritis progressing for \< 3 months.
* Rheumatoid arthritis onset at \< 18 years of age.
* Participation in another clinical study.
* Rheumatoid arthritis related connective tissue disorder.
* Any neuropsychological disorders.

Primary outcomes:
measure: Describe medications used in the treatment of rheumatoid arthritis with < 2 years' progression.
timeFrame: Single observational visit [Day 1]
Secondary outcomes:
measure: Measure disease activity using DAS 28 assessment.
timeFrame: Single observational visit [Day 1]
measure: Assess joint damage using the modified SHARP method.
timeFrame: Single observational visit [Day 1]
measure: Assess functional status of patients using the Health Assessment Questionnaire (HAQ).
timeFrame: Single observational visit [Day 1]
Other outcomes:
Locations:
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: