louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04454892: Natural History and Clinical Features of Amyotrophic Lateral Sclerosis (ALS)
Official title: A Study on the Natural History and Clinical Features of Amyotrophic Lateral Sclerosis (ALS) in Mainland China
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Amyotrophic Lateral Sclerosis
Keywords: amyotrophic lateral sclerosis; Epidemiology
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2020-07-02
Enrollment: 3000
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: ALS patients in mainland China.

Brief summary: 1. Describe the distribution of ALS in mainland China, to explore the differences in the number of ALS in different times, regions and populations in order to further explore the causes affecting the distribution of ALS;
2. To investigate the cause of ALS in mainland China in the crowd disease development process and the corresponding characteristics change ;
3. To explore the effect of prognosis of ALS;

Detailed description: With the development of supportive measures, the natural history of ALS has changed. Researchers compared the natural history of ALS patients from 1999-2004 and 1984-1998 and found that the median survival time was significantly longer in the former than in the latter (4.32 years vs. 3.22 years) and that the disease progression was slower in the former, even after adjusting for other confounding factors. Although previous studies have provided reference for the diagnosis and treatment of ALS, the etiology of ALS is still unknown, and the relevant clinical features and natural history of ALS still lack the verification of large samples. Therefore, the research on the natural history of ALS is of great significance to further increase the understanding of ALS and provide new evidence for the diagnosis and treatment of ALS.

Eligibility criteria: Inclusion Criteria:

- Patients were diagnosed with ALS recruited from all participant clinical centers.The diagnosis of ALS was made using the revised El Escorial criteria for definite, probable, lab-supported, and possible.

Exclusion Criteria:

* Decline to follow-up.

Primary outcomes:
measure: Overall Survival
timeFrame: 5 years to 10 years after recruitment
measure: Indicators of disease progression
timeFrame: 1 year to 10 years after recruitment
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
Study officials:
affiliation: Peking University Third Hospital
name: Dongsheng Fan, MD.PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00000192: Neurobiology of Opioid Dependence: 1 - 1
Official title: Neurobiology of Opioid Dependence: 1
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Opioid-Related Disorders
Keywords: opioid disorders
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 1999-09-21
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effects of lamotrigine on naloxone-precipitated opiate withdrawal.


Eligibility criteria: Please contact site for information.

Primary outcomes:
measure: Behavioral, subjective, measures of naloxone-precipitated opiate withdrawal
measure: Phsyiological, neuroendocrine measures of naloxone-precipitated opiate withdrawal
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: VA Connecticut Healthcare System
state: Connecticut
Study officials:
affiliation: VA Connecticut Healthcare System
name: Marc I Rosen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rosen MI, Pearsall HR, Kosten TR. The effect of lamotrigine on naloxone-precipitated opiate withdrawal. Drug Alcohol Depend. 1998 Oct 1;52(2):173-6. doi: 10.1016/s0376-8716(98)00057-x.
Clinical trial NCT00427492: Effect of Postoperative Laxative on Bowel Function After Colonic Surgery
Official title: Effect of Postoperative Laxative on Bowel Function After Colonic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Colonic Cancer
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2007-01-29
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Randomised doublet blinded study of the effect of tablet Magnesia (laxative) on post operative bowel ileus after open colonic resection. Material: 56 patients in two equal groups. Primary endpoint: Bowel function. Secondary endpoints: Intake of food and drinks.


Eligibility criteria: Inclusion Criteria:

* Patients with planned elective colonic resection

Exclusion Criteria:

* Previous extended abdominal surgery
* Pregnancy
* Opioid or alcohol abuse

Primary outcomes:
measure: Time to defecation after colonic resection
timeFrame: 2-8 days
Secondary outcomes:
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Copenhagen University hospital Hvidovre
Study officials:
affiliation: Copenhagen University Hospital, Hvidovre
name: Jens Andersen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01922492: Effect of Islet Autotransplantation Compared to Oral Antidiabetic Drug.
Official title: Effect of Islet Autotransplantation Compared to Oral Antidiabetic Drug in Partially Pancreatectomized Patients Due to Benign Pancreatic Neoplasm.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Partial Pancreatectomy Due to Benign Pancreatic Neoplasm
Keywords: autologous islet transplantation
partial pancreatectomy
pancreatogenic diabetes
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Health & Welfare, Korea
name: Novartis
First posted: 2013-08-14
Enrollment: 28
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: * Effects of autologous islet transplantation were compared to those of oral anti-diabetic drugs after distal pancreatectomy.
* The primary interest is a insulin-secretory function after the surgery in two intervention groups.


Eligibility criteria: Inclusion Criteria:

* Patients who underwent distal pancreatectomy for pathologic diagnosis of pancreatic mass

Exclusion Criteria:

* Prior history of diabetes mellitus
* Patients whose fasting, post-load (75g OGTT) glucose or HbA1c level meet ADA diagnostic criteria
* Patients who refused to participate the study

Primary outcomes:
measure: Changes of insulin secretory function
timeFrame: preop., 1 week and 1 month postop., and every 3 months after the surgery until 5 year postop.
Secondary outcomes:
measure: Changes of glucose tolerance
timeFrame: preop., 1 week and 1 month postop., and every 3 months after the surgery until 5 year postop.
measure: Incidence of postoperative diabetes mellitus
timeFrame: preop., 1 week and 1 month postop., and every 3 months after the surgery until 5 year postop.
measure: Changes of insulin resistance
timeFrame: preop., 1 week and 1 month postop., and every 3 months after the surgery until 5 year postop.
measure: Adverse effects
timeFrame: preop., 1 week and 1 month postop., and every 3 months after the surgery until 5 year postop.
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Kyong Soo Park
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yoon JW, Jung HS, Jang JY, Kim MJ, Kim JH, Ohn JH, Kim JH, Lee HM, Kim HC, Lee KB, Choi SA, Kim SW, Park KS. Improved Insulin Secretion by Autologous Islet Transplantation, Compared to Oral Antidiabetic Agents, After Distal Pancreatectomy. Cell Transplant. 2015;24(8):1615-26. doi: 10.3727/096368914X682440. Epub 2014 Jun 27.
Clinical trial NCT01472692: Study of Febuxostat Effect on Blood Pressure in Patients With High Normal Blood Pressure
Official title: Treatment of Uric Acid With the Xanthine Oxidase Inhibitor Febuxostat: Effects on Blood Pressure, Metabolic Markers, and Aortic Stiffness in Prehypertensive
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Prehypertension
Gout
Pulse Wave Velocity
Hypertension
24 Hour Blood Pressure
Keywords: Prehypertension
Gout
Puls Wave Velocity
Hypertension
24 hour blood pressure
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2011-11-16
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: High normal blood pressure, also called prehypertension, is a significant problem. High uric acid in the blood, the same thing that causes gout, may cause higher blood pressures. The investigators plan to monitor the effects of the drug febuxostat(trade name Uloric) on blood pressure and stiffness of the main blood vessels and see if lowering uric acid has any effect.


Eligibility criteria: Inclusion Criteria:

* Prehypertensive male and female subjects with SBP =120-140 mmHg or DBP =80-90 mmHg (as determined by seated office BP).
* Plasma uric acid level ≥5 mg/dl
* Ages 18-50
* non-smokers
* Subjects will need to remain in the San Diego area for the duration of the study and be accessible by telephone or email.

Exclusion Criteria:

* no current smoking in the prior 6 months.
* Any history of any serious medical conditions requiring close monitoring from physicians- such as liver impairment, chronic kidney disease, or diabetes mellitus. Participants not currently under the care of a physician for these conditions will be eligible for the study.
* Any history of gout, hypertension, hypercholesterolemia, morbid obesity.
* Any history of use xanthine oxidase inhibitors, antihypertensives, antiglycemic, and cholesterol lowering medications
* any history of illicit drug use within the last 6 months

Primary outcomes:
measure: Changes in 24 Hour Blood Pressure
timeFrame: 8 weeks
measure: Changes in Pulse Wave Velocity
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Univerisity Of California San Diego
state: California
Study officials:
affiliation: UCSD
name: Daniel O'Connor, UCSD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Diego
name: Jason T. Davis, M.D.
role: STUDY_DIRECTOR
References:
citation: Gois PHF, Souza ERM. Pharmacotherapy for hyperuricaemia in hypertensive patients. Cochrane Database Syst Rev. 2020 Sep 2;9(9):CD008652. doi: 10.1002/14651858.CD008652.pub4.
Clinical trial NCT00238992: Study of Enteric-coated Mycophenolate Sodium (EC-MPS) With Steroid Withdrawal vs EC-MPS With Standard Steroid Regimen in de Novo Renal Transplant Recipients.
Official title: A Prospective, Randomized, Open Label, Multicenter Trial of EC-MPS With Steroid Withdrawal vs EC-MPS With Standard Steroid Regimen for the Prevention of Acute Rejection Episodes in de Novo Renal Transplant Recipients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Kidney de Novo Transplant
Keywords: Kidney, de novo transplant, steroid withdrawal, adults, EC-MPS and cyclosporine
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-10-14
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: All patients of the core study who are interested of being treated with EC-MPS will be included in an open-label extension study to collect further information on the long-term safety, tolerability and efficacy of this drug.

The purpose of this study is to evaluate the feasibility of steroid withdrawal in the setting of immunosuppression with a combination of EC-MPS, cyclosporine and steroids in de novo kidney allograft recipients.


Eligibility criteria: Inclusion Criteria

* Male or female patients undergoing first kidney transplant.
* Patients aged 18 -70 years.
* Patients receiving an ABO identical or compatible graft. Exclusion Criteria
* Multi-organ recipients (e.g. kidney and pancreas) or previous transplant with any organ other than kidney.
* Positive HBsAg test
* Pre-Transplant PRA \>50% or historical PRA \>75% Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: biopsy proven acute rejection incidence at 1 year post-transplantation
Secondary outcomes:
measure: Incidence of biopsy proven acute rejection episodes at 6 months
measure: Incidence of treated rejection episodes at 6 months and 1 year
measure: Incidence of steroid-resistant episodes at 6 months and 1 year
measure: Patient and graft survival at 1 year
measure: Cardiovascular profile (as measured by Cholesterol, HbA1, Glucose, incidence of HTA)
measure: Percentage of patients free from steroids at 6 months and 1 year
measure: Treatment safety
Other outcomes:
Locations:
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_DIRECTOR
References:
Clinical trial NCT04788992: Dementia Care Training With Virtual Reality and Support for Home Care Staff
Official title: Evaluation of a Dementia Care Training With Virtual Reality and Support Program for Home Care Staff
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Keywords: Home care staff
dementia care
virtual reality
Lead sponsor: Tzu Chi University of Science and Technology
Sponsor class: OTHER
First posted: 2021-03-09
Enrollment: 124
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: two-group cluster randomised controlled trial
Primary purpose: OTHER

Brief summary: This study aims to evaluate a dementia care training with virtual reality and peer support program on dementia care knowledge, attitude, care competence, work stress, and empathy of home care staff.

Detailed description: Home care staff often have insufficient knowledge and skills of caring people with dementia at home. Many lack empathy for those with dementia. Training courses for home care staff often are not developed according to their educational background and workplace needs.

This two-group cluster randomised controlled trial aims to evaluate a dementia care training with virtual reality and peer support program on dementia care knowledge, attitude, care competence, work stress, and empathy of home care staff.

The dementia care training consists of dementia care e-books, dementia virtual reality activity and peer support program.

The interventional group will receive a dementia care training using dementia care e-books, dementia virtual reality activity and peer support program.

The control group will only receive dementia care e-books and peer support with no dementia virtual reality activity.

Both groups will be assessed for their dementia care knowledge, attitudes, care competence, work stress and empathy at baseline, month 3, and 6.

Eligibility criteria: Inclusion Criteria:

* age 20 to 65 years
* Taiwanese nationality
* had worked as a home care staff for at least three months
* had experience in providing home care for patients with dementia
* had a mobile phone or tablet and regular access to the internet

Exclusion Criteria:

* Home care staff who do not meet the inclusion criteria
* can not provide informed consent.

Primary outcomes:
measure: Dementia Knowledge Assessment Scale
timeFrame: 6 months
measure: Approach to Dementia Questionnaire
timeFrame: 6 moths
measure: Sense of Competence in Dementia Care Staff Scale
timeFrame: 6 months
measure: Jefferson Scale of Empathy
timeFrame: 6 months
Secondary outcomes:
measure: Simple Work Stress Scale
timeFrame: 6 moths
Other outcomes:
Locations:
city: Hualien City
country: Taiwan
facility: Mennonite Social Welfare foundation
Study officials:
affiliation: Tzu Chi University of Science and Technology
name: Huei-Chuan Sung, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00453492: Risedronate Sodium in Post Menopausal Osteoporosis
Official title: A Multicenter, Prospective, Randomized, 2-Way Crossover, Open-Label Study pn Postmenopausal Women With Osteoporosis Examining Subject Satisfaction and Compliance When Risedronate Sodium (Actonel) in Administered 35mg Once a Week or 5mg Once Daily
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoporosis, Postmenopausal
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
Collaborators: name: Procter and Gamble
First posted: 2007-03-29
Enrollment: 246
Sex: FEMALE
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The primary objective is to compare subject satisfaction of once a week dosing of 35 mg Actonel to once daily dosing of 5 mg Actonel in postmenopausal osteoporotic women.

The secondary objectives are to measure compliance (50 % drug taken), and persistence, \[and urinary NTx (N-telopeptides) (optional)\].


Eligibility criteria: Inclusion Criteria:

* Five years or greater postmenopausal who present with a diagnosis of postmenopausal osteoporosis based on standard clinical practice criteria.
* Subjects must discontinue bisphosphonates, calcitonin, fluoride, glucocorticoids (≥ 5 mg prednisone or equivalent per day) and hormone replacement therapy including estrogen-related compounds at least 6 months prior to randomization. During the study, these drugs are not permitted other than the study medication, Actonel.
* Other concomitant medications should be kept to a minimum, but if the drugs are considered necessary for the subject's welfare and are unlikely to interfere with study medication, they may be given at the discretion of the Investigator.

Exclusion criteria :

* Had a history of cancer within the past 5 years. Relatively benign skin malignancies, such as basal cell carcinoma or squamous cell carcinoma, are not an exclusion criteria if the subject has been in remission for at least 6 months prior to enrollment.
* Diagnosis of hypocalcemia, hyperparathyroidism, and hyperthyroidism.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Measurement of subject satisfaction using a questionnaire at 12 and 24 weeks and a tablets counts at 12 and 24 weeks.
measure: Optional: the effects of Actonel on bone resorption will be assessed by a change of urinary NTx, after 12 and 24 weeks of treatment as compared to baseline.
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Sanofi-Aventis
Study officials:
affiliation: Sanofi-aventis, Turkey
name: Edibe Taylan
role: STUDY_DIRECTOR
References:
Clinical trial NCT00641992: Prognosis of Failure Treatment of Amebic Liver Abscess
Official title: Prognosis Factors of the Response After Medical Treatment of Amebic Liver Abscess
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Amebic Liver Abscess
Keywords: amebic liver abscess
failure
prognosis
Lead sponsor: Universidad Autonoma de San Luis Potosí
Sponsor class: OTHER
Collaborators: name: Universidad Nacional Autonoma de Mexico
name: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
name: Hospital Central "Dr. Ignacio Morones Prieto"
First posted: 2008-03-24
Enrollment: 40
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: sequential patients with clinical, ultrasonographic and serologic diagnosis (ELISA) of amebic liver abscess

Brief summary: Amebic liver abscess is the most frequent extra-intestinal form of the amoebiasis; actually the factors for predicting failure in the medical treatment are not clear. We conducted trial for determining the clinical value of paraclinical factor in this issue.


Eligibility criteria: Inclusion Criteria:

1. Clinical, ultrasonographic and serologic diagnosis (ELISA) of amebic liver abscess.
2. Both genders
3. Older 15 years

Exclusion Criteria:

1. Clinically suspected piogenous liver abscess
2. Positive hemoculture
3. Negative ELISA for amoebic antigens
4. Immunosupresion (HIV)
5. Abdominal or biliary surgery antecedents
6. Abdominal neoplasia antecedents

Primary outcomes:
measure: Failure of medical treatment
timeFrame: Day 4
Secondary outcomes:
Other outcomes:
Locations:
city: Mexico DF
country: Mexico
facility: Department of Surgery, Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubirán".
city: San Luis Potosi
country: Mexico
facility: Faculty of Medicine, Universidad Autónoma de San Luis Potosí
Study officials:
affiliation: 1. Department of Experimental Surgery, Faculty of Medicine, Universidad Autónoma de San Luis Potosí
name: Martín Sánchez-Aguilar 1, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Clinical Epidemiology, Faculty of Medicine, Universidad Autónoma de San Luis Potosí
name: Onofre Morán-Mendoza, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00755092: Effect of Doula in Nulliparas and Multiparas
Official title: Analgesic Efficacy of Doula in Nulliparous and Multiparous Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Labor Pain
Keywords: Doula
Psychological care
Labor analgesia
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
First posted: 2008-09-18
Enrollment: 150
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Psychological care during labor is considered as an important supplemental procedure for alleviating delivering stress and pain. Although Doula has been recommending that should be given for parturients, its precise effect on nulliparous and multiparous women is still unknown. The investigators hypothesized that multiparas had experienced the process of labor, but the nulliparas were not, so Doula support would produce different effect on these two population.


Eligibility criteria: Inclusion Criteria:

* Healthy term parturients
* Chinese
* 19-45 years

Exclusion Criteria:

* Organic dysfunction
* Participants younger than 19 years or older than 45 years
* Those who were not willing to or could not finish the whole study at any time
* Pregnancy-induced hypertension and diabetes mellitus

Primary outcomes:
measure: VAS pain intensity
timeFrame: From the beginning of regular contraction of uterus to the end of delivery
Secondary outcomes:
measure: Ramsey sedative scale
timeFrame: From the beginning of regular contraction of uterus to the end of delivery
measure: Blood levels of corticosteroid
timeFrame: 10 min prior to Doula, 5, 10, 15, 30, 60, 120 min after Doula support and at the end of the delivery
measure: Vital signs
timeFrame: From the beginning of regular contraction of uterus to the end of delivery
measure: Adverse events
timeFrame: From the beginning of regular contraction of uterus to the end of delivery
measure: Infant outcomes
timeFrame: The time of delivery to 1 h after delivery
measure: Cesarean rate
timeFrame: During the whole period of laboring
measure: Overall feeling of satisfaction of analgesia
timeFrame: From the beginning of regular contraction of uterus to the end of the labor
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: Nanjing Medical University
name: XiaoFeng Shen, MD
role: PRINCIPAL_INVESTIGATOR
References: