louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01552265: Shanghai Mild Cognitive Impairment Cohort Study
Official title: Shanghai Cohort Study on Mild Cognitive Impairment for Early Detection of Alzheimer's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mild Cognitive Impairment
Keywords: Mild Cognitive Impairment
Alzheimer's Disease
Lead sponsor: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Sponsor class: OTHER
Collaborators: name: Fudan University
First posted: 2012-03-13
Enrollment: 400
Sex: ALL
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects

Brief summary: This study was planned 1) to identify individuals with Mild Cognitive Impairment (MCI) who convert to Alzheimer's Disease (AD), and 2) to explore factors associated with the conversion.


Eligibility criteria: Inclusion Criteria:

1. Cognitive concern reflecting a change in cognition reported by the patient or informant or clinician
2. Mini-Mental State Examination (MMSE) scores between 18-30 (inclusive)
3. Clinical Dementia Rating (CDR) =0.5; Memory Box score must be at least 0.5
4. Objective memory loss\* as evidenced by Auditory Verbal Learning test (AVLT-HS)
5. Essentially preserved activities of daily living based on Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)
6. Not-demented, as defined by '"All-cause Dementia" (see 3.4. All-cause Dementia)
7. Willing to and able to undergo all test procedures including neuroimaging, and agree to longitudinal follow up
8. Written informed consent for the participation of this study including repeated neuropsychological tests and MRI scans

Primary outcomes:
measure: Time to Conversion from MCI to "Probable AD Dementia"
timeFrame: 3 years
Secondary outcomes:
measure: Time to Conversion from MCI to "Possible AD Dementia" or "Probable AD Dementia"
timeFrame: 3 years
measure: Time to Conversion from MCI to "All-cause Dementia"
timeFrame: 3 years
measure: Overall survival
timeFrame: 3 years
measure: Changes in Neuropsychological examinations
timeFrame: baseline, annual and 3 years
measure: Changes in MRI
timeFrame: baseline, annual and 3 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Neurology, Huashan Hospital, Fudan University
state: Shanghai
Study officials:
affiliation: Translational Research Informatics Center, Foundation for Biomedical Research and Innovation, Kobe,Japan
name: Yoji Nagai, MD,PhD
role: STUDY_DIRECTOR
References:
citation: Zhou B, Zhao Q, Kojima S, Ding D, Higashide S, Nagai Y, Guo Q, Kagimura T, Fukushima M, Hong Z. One-year Outcome of Shanghai Mild Cognitive Impairment Cohort Study. Curr Alzheimer Res. 2019;16(2):156-165. doi: 10.2174/1567205016666181128151144.
Clinical trial NCT04832165: Inspiratory Muscle Training on Diaphragm Thickness, Inspiratory Muscle Pressure and Physical Function
Official title: Effects of Inspiratory Muscle Training on Diaphragm Thickness, Inspiratory Muscle Pressure and Physical Function in Healthy Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Universidad Francisco de Vitoria
Sponsor class: OTHER
First posted: 2021-04-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Fatigue of the respiratory muscles is one of the limitations of exercise at high intensity, although the mechanisms that explain it are not yet clear. This fatigue would cause a decrease in physical performance and could limit the functional capacity of the subject. In this sense, it has been shown that specific training of respiratory muscles, especially inspiratory muscles, improves their strength and resistance both in healthy people and in people with pathologies; managing to improve the quality of life and both physical and sports performance. This study, which follows the quantitative method and proposes an analytical, experimental, longitudinal and prospective design (with the aim of conducting a randomized clinical trial), proposes an intervention based on performing a specific training of inspiratory muscles for 8 weeks, taking 30 maximum inspirations at 60% of the PIM (maximum inspiratory pressure), 2 times a day for 5 days a week; with the aim of assessing the effects on inspiratory function, cardiorespiratory fitness when performing a stress test (Harvard step test) and diaphragm thickness measured by ultrasound. 40 healthy subjects between 18 and 25 years old will be recruited and divided into two groups: an experimental group (n = 20) and a control group (n = 20).


Eligibility criteria: Inclusion Criteria:

* healthy university students

Exclusion Criteria:

* Suffering or having suffered aortic aneurysm; pneumothorax; rib wall or pulmonary fistulas; recent trauma or surgery to the upper airway or thoracoabdominal; recent myocardial infarction or angina; retinal detachment, glaucoma, or recent eye surgery; increased intracranial pressure (tonsillar wedge, meningocele, hydrocephalus); abdominal hernias and acute middle ear problems.

Primary outcomes:
measure: Diaphragm muscle thickness
timeFrame: Change from baseline diaphragm muscle thickness at 8 weeks
Secondary outcomes:
measure: Inspiratory muscle strength
timeFrame: Change from baseline inspiratory muscle strength at 8 weeks
measure: Physical Efficiency Index
timeFrame: Change from baseline physical efficiency index at 8 weeks
Other outcomes:
Locations:
city: Pozuelo de Alarcón
country: Spain
facility: Universidad Francisco de Vitoria
state: Madrid
Study officials:
affiliation: Universidad Francisco de Vitoria
name: Berlanga
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01453465: Biomarker Study in Samples From Patients With Malignant Rhabdoid Tumor of the Kidney or Atypical Teratoid Rhabdoid Tumor
Official title: Gene Expression (GE) and MicroRNA (MIRNA) Expression Profiles of Malignant Rhabdoid Tumors (MRT) of the Kidney (RTK) and Atypical Teratoid Rhabdoid Tumor (ATRT)
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Childhood Atypical Teratoid/Rhabdoid Tumor
Rhabdoid Tumor of the Kidney
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2011-10-17
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Sampling method: NON_PROBABILITY_SAMPLE

Brief summary: This research trial studies biomarkers in samples from patients with rhabdoid tumor of the kidney and atypical teratoid rhabdoid tumor. Studying biomarkers of tissue samples from patients with cancer in the laboratory may help doctors learn more about changes the occur in DNA and identify biomarkers related to cancer.

Detailed description: PRIMARY OBJECTIVES:

I. To determine if there are molecular differences between rhabdoid tumor of the kidney (RTK) and the atypical teratoid rhabdoid tumor (ATRT).

OUTLINE:

Archived tumor tissue samples are analyzed for gene expression profile and microRNA profile.

Eligibility criteria: Inclusion Criteria:

* Samples of RTK and ATRT provided by the Children?s Oncology Group (COG)

Primary outcomes:
measure: Molecular differences between RTK and the ATRT
timeFrame: Up to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Childrens Oncology Group
state: Pennsylvania
Study officials:
affiliation: Children's Oncology Group
name: Simone Sredni
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00620165: Efficacy of Levetiracetam in Essential Tremor
Official title: Efficacy of Levetiracetam in Patients With Essential Tremor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Essential Tremor
Keywords: tremor
writing
feeding
pouring
Lead sponsor: Southern California Institute for Research and Education
Sponsor class: OTHER
First posted: 2008-02-21
Enrollment: 10
Sex: ALL
Minimum age (years): 25
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Essential tremor poses one of the greatest therapeutic challenges to neurologists. This study will examine the effectiveness of the drug, levetiracetam or keppra, for the treatment of essential tremor.

Detailed description: Currently available pharmacological treatments for essential tremor are hampered by relatively low efficacy and intolerable side effects. Recent evidence indicates that levetiracetam (LEV) may modulate the dopaminergic system. In this regard LEV has been shown to reduce L-dopa-induced dyskinesias, tardive dyskinesia and myoclonus, and is relatively well-tolerated in the elderly. Previous studies examined the efficacy of LEV for the treatment of essential tremor. However, these were either open label or relatively short duration studies. A longer term study of LEV for the treatment of essential tremor is therefore warranted. In this randomized, double-blind, placebo-controlled crossover study, ten subjects with essential tremor will be randomly assigned to receive either LEV up to a maximum dose of 3000 milligrams (mg) per day or placebo. Study drug will be titrated up over 6 weeks and continued at 1500 mg twice daily for an additional 6 weeks. Following a 4 week washout period subjects will cross over to the other arm and continued for an additional 12 weeks. Subjects will be evaluated monthly by a blinded examining neurologist and research coordinator. At each study visit subjects will receive a neurological examination and will be evaluated using a 16-item scale for tremor and medication side effects. The data derived from study drug vs. placebo groups will be compared using the Mann-Whitney U and Wilcoxon W tests.

Eligibility criteria: Inclusion Criteria:

* History of tremor for 5 or more years
* No other neurological problems

Exclusion Criteria:

* Prior stroke or other neurological disease, psychiatric problems
* History of renal disease
* Pregnancy

Primary outcomes:
measure: Performance on a 16-item tremor rating scale including degree of tremor, writing, pouring and feeding.
timeFrame: 12 weeks per treatment arm
Secondary outcomes:
measure: Assessment of adverse side effects.
timeFrame: 12 weeks per arm
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: VA Long Beach Healthcare System
state: California
Study officials:
affiliation: Southern California Institute for Research and Education
name: Steven S Schreiber, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02801565: Clinical Observation of Recombinant Human Growth Hormone Injection Assisted IVF-ET in the Treatment of PCOS
Official title: Clinical Observation of Recombinant Human Growth Hormone Injection Assisted in Vitro Fertilization and Embryo Transfer (IVF-ET) in the Treatment of Polycystic Ovary Syndrome (PCOS)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Polycystic Ovary Syndrome
Lead sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Peking University Third Hospital
First posted: 2016-06-16
Enrollment: 208
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Observe validity of Recombinant Human Growth Hormone Injection assisted in IVF-ET (in vitro fertilization and embryo transfer) treatment of PCOS (polycystic ovary syndrome) patients.


Eligibility criteria: Inclusion Criteria:

* Age between 25 and 35 years old, married female and infertile.
* BMI≥25kg/m2.
* Diagnosed as PCOS.
* No obvious chronic organic diseases, such as liver, kidney, heart, lung, thyroid, adrenal disease.
* Subjects do not take part in other clinical trial study within 3 months.
* The subjects sign the informed consent form.

Exclusion Criteria:

* BMI\<25kg/m2.
* Hyperprolactinemia and congenital adrenal cortical hyperplasia.
* Diabetes, thyroid function hyperthyroidism, thyroid dysfunction, cushing's syndrome.
* Pelvic and peritoneal tumor and tumor secreting hyperandrogenism.
* Severe acute and chronic liver and kidney disease, such as liver cirrhosis, acute and chronic renal failure, hepatitis B virus activity.
* Liver and kidney dysfunction, AST/ALT is 2.5 times higher than the normal limit, the serum of creatinine is 2 times higher than the normal level.
* Diseases affecting outcome of IVF pregnancy, eg, hydrosalpinx, hysteromyoma\>4 cm, adenomyosis, endometriosis, endometrial cyst of ovary, unilateral ovary, tuberculosis of reproductive system.
* Allergic to E. coli. expression product and its excipients.
* Being involved in other drug clinical researchers.
* The researchers consider who is not suitable for the group.

Primary outcomes:
measure: Clinical pregnancy rate
timeFrame: One year
measure: Number of fertilized oocytes
timeFrame: One year
Secondary outcomes:
measure: Number of retrieved oocytes
timeFrame: One year
measure: Number of high quality embryos
timeFrame: One year
measure: Number of transferred embryos
timeFrame: One year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
Study officials:
affiliation: Peking University Third Hospital
name: Ying Wang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00314665: Use of Thalidomide in Chronic Uveitis
Official title: Use of Thalidomide in Chronic Uveitis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Uveitis
Keywords: Sarcoidosis
Chronic Uveitis
Uveitis
Thalidomide
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
Collaborators: name: Celgene Corporation
First posted: 2006-04-14
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This research study is for patients that have been diagnosed with chronic uveitis, a disease that causes inflammation in the eye. Patients are currently being treated with Remicade, Humira, Methotrexate and or similar chemotherapy type drugs to control this inflammation. Despite these medications, patients still have inflammation in their eyes. Patients are being asked to add an additional drug, thalidomide.

Detailed description: Patients will be in the study for approximately 24 weeks. The visits are at screening, baseline (week 0), and weeks 4,8,12, and 24.

The purpose of this research study is to see if Thalidomide is safe and effective in the treatment of patients with chronic inflammation in their eyes. Thalidomide is approved by the Food and Drug Administration (FDA) for a leprosy skin condition, erythema nodosum leprosum (ENL). The drug works in many different ways, including as an anti-inflammation drug. Therefore, it is thought that this drug might be able to improve symptoms and lung function. At this time, the drug is not approved for use for uveitis.

Eligibility criteria: Inclusion Criteria:

* You are being asked to take part in this research study because you have been diagnosed with chronic uveitis, a disease that causes inflammation in the eye. You are currently being treated with Remicade, Humira, Methotrexate and or similar chemotherapy type drugs to control this inflammation. Despite these medications, you still have inflammation in your eyes. You are being asked to add an additional drug, thalidomide.

Exclusion Criteria:

* You will not participate in this research study if any of the following apply to you:

  * Pregnant
  * If you are a man or woman not willing to take adequate birth control measures comply with FDA-mandated S.T.E.P.S.â program. .
  * If you are a breast feeding woman
  * If you have a significant peripheral neuropathy (numbness or tingling in your hands or feet)
  * Have had a recent blood clot in your leg or lungs
  * If you are currently receiving biphosphonates such as zoledronic acid (fosamax)

Primary outcomes:
measure: Need for corticosteroids to control eyes
measure: Global assessment of ocular status
Secondary outcomes:
measure: Toxicity
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
Study officials:
affiliation: Professor of Medicine
name: Robert P Baughman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01576965: Mechanical Bowel Preparation Before Laparoscopic Hysterectomy and Laparoscopic Sacrocolpopexy: a Randomized Controlled Trial
Official title: Mechanical Bowel Preparation Before Laparoscopic Hysterectomy and and Laparoscopic Sacrocolpopexy: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laparoscopic Hysterectomy and/or Laparoscopic Sacrocolpopexy
Keywords: Laparoscopic hysterectomy,laparoscopic sacrocolpopexy,bowel prep
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2012-04-13
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to learn about bowel preparation (cleansing) before laparoscopic hysterectomy and/or sacrocolpopexy. We are most interested in the ability of the surgeon to view necessary anatomy for the surgery, which will be assessed by a questionnaire completed at the end of your operation by the surgeon. We hypothesize that bowel preparation before laparoscopic hysterectomy will result in improved ability of the surgeon to view necessary anatomy for the surgery.


Eligibility criteria: Inclusion Criteria:

* Women undergoing planned laparoscopic hysterectomy, with or without concomitant sacrocolpopexy, for benign indications with members of the Advanced Laparoscopy \& Pelvic Pain division and the Urogynecology division at UNC.

Exclusion Criteria:

* Patients with known or suspected malignancy and those with severe endometriosis of the posterior cul-de-sac where bowel resection
* Pregnant women.
* Women under 18 years old.
* Women who cannot provide informed consent.

Primary outcomes:
measure: Surgeon's assessment of surgical field visual quality
timeFrame: immediately after surgery
Secondary outcomes:
measure: Surgeon evaluation of patient outcomes
timeFrame: immediately after surgery
measure: Patient reported satisfaction
timeFrame: immediately prior to surgery
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC Department of Obstetrics and Gynecology
state: North Carolina
Study officials:
affiliation: UNC OB-GYN Division of Advanced Laparoscopy and Pelvic Pain
name: Matthew Siedhoff, MD, MSCR
role: PRINCIPAL_INVESTIGATOR
References:
citation: Siedhoff MT, Clark LH, Hobbs KA, Findley AD, Moulder JK, Garrett JM. Mechanical bowel preparation before laparoscopic hysterectomy: a randomized controlled trial. Obstet Gynecol. 2014 Mar;123(3):562-567. doi: 10.1097/AOG.0000000000000121.
Clinical trial NCT02668965: The Effects of Intrauterine Infusion of hCG at the Time of Embryo Transfer
Official title: The Effects of Intrauterine Infusion of Human Chorionic Gonadotropin at the Time of Embryo Transfer on IVF/ICSI Outcomes: Randomized, Double-blind Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infertility
Keywords: Clinical pregnancy rate
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2016-01-29
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to determine whether intrauterine hCG can improve the implantation rate and clinical pregnancy rate after embryo transfer in IVF/ICSI cycle.

Detailed description: Patients at infertility clinic, siriraj hospital who come to start IVF/ICSI treatment cycle or endometrial preparation for embryo transfer are consiferes as eligible subjects.

On the day of embryo transfer (both fresh and frozen-thaw cycle), the subjects will be randomized to 2 groups.

1. control group: embryo transfer after intrauterine infusion with standard embryo culture media 4-7 minutes
2. study group: embryo transfer after intrauterine infusion with hCG (Pregnyl) 4-7 minutes

The patients will come back for serum beta-hCG measurement 2 weeks later after embryo transfer and other 2 weeks later for transvaginal ultrasound if beta-hCG is positive.

Eligibility criteria: Inclusion Criteria:

1. infertile women aged 18-43 years
2. indicated or willing for IVF/ICSI treatment or endometrial preparation for embryo transfer

Exclusion Criteria:

1. Azoospermic male partner
2. Failure to retrieve oocyte after controlled ovarian hyperstimulation
3. No embryo retrieved for transfer
4. Endometrial preparation failure

Primary outcomes:
measure: Clinical pregnancy rate
timeFrame: 2 weeks after positive serum beta-hCG
Secondary outcomes:
measure: Chemical pregnancy rate
timeFrame: 2 weeks after embryo transfer
measure: Implantation rate
timeFrame: 2 weeks after positive serum beta-hCG
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Infertility unit, Siriraj Hospital
Study officials:
References: