louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01908400: Safety and Efficacy of BMMNCin Patients With Mental Retardation
Official title: An Open Labeled Clinical Study to Evaluate the Safety and Efficacy of Autologous Bone Marrow Derived Mono Nuclear Stem Cell (BMMNCs) in Patients With Mental Retardation. It is Self Funded (Patients' Own Funding) Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Mental Retardation
Keywords: Mental retardation , stem cell,BMMNC
Lead sponsor: Chaitanya Hospital, Pune
Sponsor class: OTHER
First posted: 2013-07-25
Enrollment: 15
Sex: ALL
Minimum age (years): 5
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Mental retardation is a condition diagnosed before age 18 that includes below-average general intellectual function, and a lack of the skills necessary for daily living. Mental retardation affects about 1 - 3% of the population. There are many causes of mental retardation, but find a specific reason in only 25% of cases.Bone marrow derived stem cells are used in this condition to prove its safety and efficacy .


Eligibility criteria: Inclusion Criteria:

* Age limit: 5 -50
* Primary diagnosis of mental retardation (IQ \< 70)
* willingness to undergo Autologous Bone Marrow derived Mono Nuclear Stem Cell (BMMNCs) transplantation.
* To give an informed consent as well as sign the required Informed Consent Form (ICF)/video Consent for the study.
* willingness to regularly visit the hospital / clinic for follow up during the follow up period / on prior agreed time points as per the protocol.

Exclusion Criteria:

* Positive test results for HIV and AIDS complex ,HCV (hepatitis C virus ), HbsAg and Syphilis
* Advanced age that may produce deteriorating cognitive or motor functioning
* Multiple sensory or motor disabilities that will interfere with seeing the stimuli and responding to the computer
* Poor general health

Primary outcomes:
measure: Binet-Kamat Test
timeFrame: 1 YEAR
Secondary outcomes:
measure: Vineland Social Maturity Scale
timeFrame: baseline and 12 months
Other outcomes:
Locations:
city: Pune,
country: India
facility: Chaitanya Hospital
state: Maharashtra
Study officials:
affiliation: Chaitanya Hospital
name: ANANT E BAGUL, MS ORTHO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01103700: Evaluation of Multidisciplinary Palliative Care on Terminal Cancer Patients in Taiwan
Official title: Evaluation of Multidisciplinary Palliative Care on Terminal Cancer Patients in Taiwan
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer
Keywords: Quality of dying and death of terminal cancer patients
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2010-04-15
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Main care givers of deceased patients

Brief summary: The purpose of the study is to compare the quality of dying and death of terminal cancer patients from the perspectives of medical staff and main care giver (family). The hypothesis is that their view points will be different.


Eligibility criteria: Inclusion Criteria:

* Cognitively intact.
* Contact with the patient in the last month.

Exclusion Criteria:

* Cognitively not intact.
* No contact with the patient in the last month.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei, Taiwan
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Shao-Yi Cheng, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02493400: Physiotherapist Led Group-exercise Compared Physical Activity on Prescription, a 3 Months Follow-up
Official title: Physiotherapist Led Group-exercise Compared Physical Activity on Prescription in Older Patients With Atrial Fibrillation, a 3 Months Follow-up
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Keywords: Follow up
Exercise
Rehabilitation
Lead sponsor: Göteborg University
Sponsor class: OTHER
First posted: 2015-07-09
Enrollment: 87
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have completed the primary study will be offered a follow-up after 3 months

Brief summary: To investigate the effect of exercise or PAP prescription 3 months after completion of the study "Should elderly patients with atrial fibrillation be offered physiotherapist group exercise or can physical activity on prescription (PAP) be used as an alternative?" regarding level of physical fitness, physical activity, heart rate and health related quality of life (HR-QoL). Also if any of the investigated variables can predict the possible change in physical fitness.

Detailed description: Patients who have completed study will be offered a follow-up after 3 months regarding physical fitness, physical activity, heart rate and HR-QoL. Physical fitness will be measured by a symptom limited bicycle test and a muscle endurance test. Physical activity will be measured by accelerometer and the International Physical Activity Questionnaire (IPAQ) and a physical activity diary, HR-QoL will be measured by short form (SF-36).

Eligibility criteria: Inclusion Criteria:

* Completed the study "Should elderly patients with atrial fibrillation be offered physiotherapist group exercise or can physical activity on prescription (PAP) be used as an alternative?"

Exclusion Criteria:

* Not completed the above study or denied participation in follow up

Primary outcomes:
measure: Physical fitness
timeFrame: 3 months follow up
Secondary outcomes:
measure: Physical activity
timeFrame: 3 months follow up
measure: Health related quality of life
timeFrame: 3 months follow up
Other outcomes:
Locations:
city: Göteborg
country: Sweden
facility: Sahlgrenska university hospital and Alingsås hospital
Study officials:
affiliation: Institute of Neuroscience and Physiology/Physiotherapy
name: Asa Cider, Phd RPT
role: STUDY_DIRECTOR
References:
Clinical trial NCT03926000: Pregabalin Premedication for Knee Arthroscopy
Official title: The Effect of Pregabalin Premedication on Anaesthetic Requirements and Recovery Time After Knee Arthroscopy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Knee Arthroscopy
Lead sponsor: Menoufia University
Sponsor class: OTHER
First posted: 2019-04-24
Enrollment: 112
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Outpatient arthroscopic knee surgery can be performed with general or regional anesthesia. Recent data suggest that spinal and epidural anesthesia require longer discharge times than the newer shorter-acting general anesthetic drugs. Ideal premedication drug should relieve anxiety, produce amnesia and sedation, decrease secretions, prevent nausea and vomiting, have dose sparing effect on the anaesthetic drugs, and suppress pressor response to laryngoscopy and intubation. Recently, gabapentin and pregabalin were suggested as pre-operative drugs to decrease anxiety, stress response to laryngoscopy and post operative pain.

Detailed description: 112 patients undergoing elective knee arthroscopy will randomly divided into two equal groups, 56 patients each. All patients will receive premedication one hour before the procedure. PG group will receive 150 mg pregabalin and C group will receive placebo. All patients will receive total intravenous anesthesia to achieve optimum working conditions. Intra-operative total amount of anesthetics will be compared in both groups.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled for elective knee arthroscopy.
* Patients aged between 21 and 50 years old.
* Patients with American Society of Anaesthesiologists physical status I or II.

Exclusion Criteria:

* Patients with known allergy to any drug used in the study.
* Patients with chronic use of analgesics and/or sedatives.
* Patients with sleep apnea syndrome.
* Patients with renal or hepatic dysfunction.
* Patients with psychiatric disorders.

Primary outcomes:
measure: Total amount of anesthetics
timeFrame: 45 minutes during the procedure
Secondary outcomes:
measure: Patients' satisfaction: satisfaction score
timeFrame: 30 minutes after the end of the procedure
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03918200: Serum Amyloid A in Women With Unexplained Infertility
Official title: Serum Amyloid A Level in Women With Unexplained Infertility
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Lead sponsor: Ain Shams Maternity Hospital
Sponsor class: OTHER
First posted: 2019-04-17
Enrollment: 90
Sex: FEMALE
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Infertile women attending Ain Shams University infertility outpatient clinic seeking fertility and fulfilling the criteria.

Brief summary: High follicular fluid amyloid A level is associated with reduced pregnancy rate.

The aim of this study was to find an association between serum level of amyloid A and unexplained infertility.


Eligibility criteria: Inclusion Criteria:

1. women with unexplained infertility (unprotected, regular intercourse for at least 2 years).
2. Nulligravida ,Regular mensturation.
3. Age less than 40 years .
4. Normal parameters (in the study group):

   * hormonal profile (day 2 FSH,LH), midluteal phase progesterone, Prolactin, TSH
   * transvaginal ultrasound
   * hysterosalpingography
   * detailed semen analysis

Exclusion Criteria:

1. Age above 40
2. Smoking females
3. Obesity (BMI\>30)
4. Women with any systemic or medical diseases leads to elevation of SAA as:

   1. Systemic lupus erythematosis
   2. Rheumatoid arthritis
   3. Sarcoidosis
   4. Diabetes Mellitus
5. Using hormonal contraception (for control group)

Primary outcomes:
measure: Difference between SAA level between cases and control.
timeFrame: 1 day (once)
Secondary outcomes:
measure: Correlation between SAA level with other parameters in the hormonal profile (e.g., FSH, LH, E2).
timeFrame: 1 day (once)
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Hospital
Study officials:
References:
Clinical trial NCT06163300: MRI Analysis and Degenerative Spine
Official title: MRI Analysis and Degenerative Spine
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Spine Disease
Lead sponsor: Universidade Nova de Lisboa
Sponsor class: OTHER
First posted: 2023-12-08
Enrollment: 200
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with suspected diagnosis of the spinal disease in study and that meet the eligibility criteria.

Brief summary: Analysis of MRI advanced techniques in degenerative spinal disease.

The main questions it aims to answer are:

* Can we assess microstructural integrity of compressed nerve roots in degenerative spinal disease
* What are the image biomarkers affected by disease
* How they evolve with disease progression and treatment


Eligibility criteria: Inclusion Criteria:

* Age between 50 and 85 years
* Diagnosis of spinal disease by clinical and imagiological criteria
* More than 3 months duration of disease
* Ability to give consent
* Fluent portuguese speaker

Exclusion Criteria:

* Previous spine surgery
* Spinal instability
* Neurological disease that might interfere with walking
* Known orthopedic conditions that causes significant gait impairment
* Dementia or development disorder with cognitive impairment
* Inability to give consent

Primary outcomes:
measure: ODI - Oswestry Disability Index
timeFrame: 18 months
measure: Lumbar Pain Intensity
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Setúbal
country: Portugal
facility: Hospital da Luz Setúbal
Study officials:
References:
Clinical trial NCT06095700: First Rib Resection Versus Avulsion for Thoracic Outlet Syndrome
Official title: First Rib Resection Versus Avulsion for the Management of Thoracic Outlet Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Thoracic Outlet Syndrome
Lead sponsor: University of Sulaimani
Sponsor class: OTHER
First posted: 2023-10-23
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The management of thoracic outlet syndrome can be either surgical or nonsurgical. Fewer than 20% of patients experience benefits from nonsurgical treatments. Regarding the surgical approach, there's considerable debate about whether to resect the first rib or if a scalenectomy alone suffices. Recently, many experts have concurred on the resection of the first rib. Based on our observations, avulsion of the first rib results in improved outcomes and reduced post-operative pain compared to simple resection. Thus, this study aims to compare the outcomes of first rib resection versus its avulsion in patients with thoracic outlet syndrome.


Eligibility criteria: Inclusion Criteria: any patient diagnosed as a case of neurogenic thoracic outlet syndrome -

Exclusion Criteria: patients with other types of thoracic outlet syndrome (vascular TOS)

-

Primary outcomes:
measure: patient satisfaction
timeFrame: six months
measure: post operative pain
timeFrame: four weeks after the operation
Secondary outcomes:
Other outcomes:
Locations:
city: Sulaymaniyah
country: Iraq
facility: Smart Health Tower
Study officials:
affiliation: University of Sulaimani
name: fahmi Kakamad, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00061100: HIV Counseling Intervention for Methadone-Maintained Patients - 2
Official title: HIV Counseling Intervention for Methadone-Maintained Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Opioid-Related Disorders
Keywords: HIV
methadone maintenance
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2003-05-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate HIV counseling intervention for Methadone-Maintained Patients.

Detailed description: The purpose of this proposal is to evaluate, in methadone-maintained patients the association between an ADHD diagnosis and high-risk HIV/Hepatitis behavior. In addition, the investigators would like to determine whether a new manually-guided HIV intervention; RISE: Reduce high risk Intravenous drug use and unsafe Sexual Encounters is superior to standard HIV/Hepatitis psycho-education.

Eligibility criteria: Inclusion Criteria:

* Must meet DSM-IV criteria for opiate dependence and currently in methadone maintenance treatment
* Able to give informed consent and capable of complying with study procedures
* Women who are of childbearing age and/or pregnant may be included
* Individuals who are HIV-positive or have Acquired Immunodeficiency Syndrome may be included
* Patients who demonstrate moderate to high HIV risk behaviors will be included
* Patients with low to no HIV risk behaviors will be excluded
* Patients receiving a stable dose of methadone for three weeks will be included

Exclusion Criteria:

* Currently meets DSM-IV criteria for current Axis I psychiatric disorders (other than ADHD or substance abuse) which requires medical intervention, i.e., active suicide ideation, active psychosis, anxiety disorders, depression requiring hospitalization
* Patients who have exhibited suicidal or homicidal behavior within the past two years
* HIV positive patients must have knowledge of their status for a minimum of three weeks

Primary outcomes:
measure: AIDS risk behavior based on the Risk Behavior Assessment
timeFrame: assessed monthly during 2 months of study or length of participation
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Research Foundation for Mental Hygiene, Inc.
state: New York
Study officials:
affiliation: Research Foundation for Mental Hygiene, Inc.
name: Frances R Levin, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01046500: Myo-inositol Versus Metformin Administration in Post-menopausal Women With Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Metabolic Syndrome
Keywords: insulin resistance
body mass index
myo-inositol
serum triglycerides and cholesterol
blood pressure
metformin
Lead sponsor: University of Messina
Sponsor class: OTHER
First posted: 2010-01-12
Enrollment: 100
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Myo-Inositol is classified as a member of the vitamin B complex. It is a constituent of living cells and is widespread in many food. It is involved in a number of biological processes, including insulin signal transduction, resulting in modulating insulin sensitivity. One hundred post-menopausal women from 50 to 60 years old, affected by metabolic syndrome (criteria are described in NIH ATP III) will be randomized into two groups: 50 treated with myo-inositol 2 g twice per day and fifty treated with metformin for six months. Metformin is the drug usually used in diabetic and pre-diabetic conditions, as metabolic syndrome. The investigators hypothesize that the administration of myo-inositol would improve the insulin-receptor activity in these women, reducing insulin resistance as well as metformin.

OUTCOME MEASURE: HOMA-IR, blood pressure level, serum triglycerides and cholesterol, BMI and waist circumference


Eligibility criteria: Inclusion Criteria:

* Post-menopausal outpatients affected by the metabolic syndrome, whose criteria are described in NIH ATP III, 2001.

Exclusion Criteria:

* Post-menopausal outpatients without metabolic syndrome
* assumption of hypocholesterolemic or other insulin sensitizing drugs

Primary outcomes:
measure: glycaemia, insulinaemia, HOMA-IR
timeFrame: at baseline and after 6 months
Secondary outcomes:
measure: serum triglycerides, HDL and total cholesterol, blood pressure level, BMI and waist circumference
timeFrame: at baseline and after six months
Other outcomes:
Locations:
city: Messina
country: Italy
facility: University Hospital
Study officials:
References:
Clinical trial NCT01267500: Study of Non-surgical Treatment Versus Observation in Asian Children With Intermittent Exotropia
Official title: Randomized Study of Non-surgical Treatment Versus Observation in Asian Children With Intermittent Exotropia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Intermittent Exotropia
Lead sponsor: Singapore National Eye Centre
Sponsor class: OTHER_GOV
First posted: 2010-12-28
Enrollment: 60
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Non-surgical treatment (ie. patching or fusion exercises) of intermittent exotropia may help in increasing control of strabismus


Eligibility criteria: Inclusion Criteria:

1. Age 3 to 12 years (inclusive)
2. IXT for distance or constant IXT for distance and either IXT or exophoria for near
3. IXT size of \> 10PD
4. Visual acuity in worse eye of at least 0.3 logMar (Snellen 6/12)
5. Visual acuity of no greater than 2 lines between eyes
6. Parents or guardian willing to accept randomization, and to continue with observation or treatment for at least 6-12 months, unless deterioration of strabismus or fall in best corrected visual acuity of worse than 0.3logMar (Snellen 6/12) in either eye
7. Investigator willing to observe IXT untreated for at least 1 year

Exclusion Criteria:

1. Previous non-surgical treatment for IXT, or patch treatment for amblyopia within the last year
2. Prior strabismus, intraocular or refractive surgery or botulinium injection
3. Surgery planned within the next year
4. Prematurity (birth weight \< 1500g, gestational age \< 34 weeks), systemic illness (eg. cerebral palsy), syndrome (including craniosynostosis) or learning disability
5. Any ocular abnormality (cornea, lens or central retina); nystagmus or conditions that limit eye movements.

Primary outcomes:
measure: Control of strabismus
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: SIngapore
country: Singapore
facility: SIngapore National Eye Centre
Study officials:
affiliation: Singapore National Eye Center
name: audrey chia
role: PRINCIPAL_INVESTIGATOR
References: