louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01237210: 7T MRS in Parkinson's Disease
Official title: Magnetic Resonance Spectroscopy of Parkinson's Disease at 7 Tesla
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson's Disease
Keywords: Parkinson's Disease
PD
magnetic resonance spectroscopy
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2010-11-09
Enrollment: 78
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parkinson's patients and healthy controls

Brief summary: This study is looking for healthy controls and patients with Parkinson's (PD) to perform an MR scan.

1. The neurochemical profile of the SN of patients with PD as measured by high field MRS will differ from that of healthy controls, in that glutathione will be lower due to oxidative stress, lactate will be higher due to mitochondrial dysfunction, the gliosis markers myo-inositol and glutamine will be higher due to inflammation (glial activation) and N-acetylaspartate and glutamate will be lower due to neuronal loss/damage.
2. There will be a relationship between neurochemical changes and disease severity.


Eligibility criteria: Inclusion Criteria:

Parkinson's disease Group

* Parkinson's disease (clinical diagnostic criteria)
* Age 45-75 years inclusive
* Able to safely undergo MRI scanning
* Absence of diabetes and smoking
* Capable of giving informed consent

Healthy Control Group

* Age 45-75 years inclusive
* Able to safely undergo MRI scanning
* Absence of diabetes and smoking
* Capable of giving informed consent

Exclusion Criteria:

Parkinson's disease Group

* Dementia (clinically determined by PI Dr. Tuite)
* Diagnosis of atypical parkinsonism
* Inability to safely undergo MRI scanning
* Inability to give informed consent
* Unstable medical conditions
* Present smoker
* Diabetic (on oral or injectable medications for diabetes)
* Taken coenzyme Q10 or Vitamin E in the 2 weeks prior to the scan
* Does not meet age criteria

Healthy Control Group

* Has a 1st degree relative with PD
* Dementia (clinically determined by PI Dr. Tuite)
* Inability to safely undergo MRI scanning
* Inability to give informed consent
* Unstable medical conditions
* Present smoker
* Diabetic (on oral or injectable medications for diabetes)
* Taken coenzyme Q10 or Vitamin E in the 2 weeks prior to the scan
* Does not meet age criteria

Primary outcomes:
measure: Magnetic resonance spectroscopy (MRS)
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota/CMRR
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Paul Tuite, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00965510: SeaCare's Care Coordination for Diabetes Management in a Primary Care Office
Official title: Improved Management of Type II Diabetes in a Primary Care Office With Targeted Case Management
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: diabetes
Lead sponsor: SeaCare Health Services
Sponsor class: OTHER
Collaborators: name: New Hampshire Charitable Foundation
First posted: 2009-08-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine whether it is possible to improve health outcomes for patients with Type II diabetes, a community-based health care agency will offer care coordination to half of a study group in a family practice office. The intervention will include assessing patients' status using two instruments:

a depression screen (the PHQ9) and a motivation to change scale (the Patient Activation Measure, PAM). A masters-level social worker will counsel patients in the intervention group. Changes in patients' health status, PHQ9 scores and PAM scores over one year will be measured. Outcomes will be compared between the study group and the group without intervention.


Eligibility criteria: Inclusion Criteria:

* Diabetes type II

Exclusion Criteria:

* Non-English speaking

Primary outcomes:
measure: Scores on PHQ9, PAM and health indicators
timeFrame: 1 year
Secondary outcomes:
measure: Satisfaction with care coordination model.
timeFrame: 1 year
Other outcomes:
Locations:
city: Exeter
country: United States
facility: Exeter Family Care
state: New Hampshire
Study officials:
affiliation: SeaCare Health Services
name: Gwendolyn Gladstone, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04254510: The Effect of Myofascial Release Technique on the Treatment of Primary Dysmenorrhea in Psoas Muscle
Official title: The Effect of Myofascial Relaxation Technique on the Treatment of Primary Dysmenorrhea in Psoas Muscle
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Woman; Primary Dysmenorrhoea
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 38
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Dysmenorrhea is a series of pathological symptoms associated with menstruation that interfere with daily activities such as abdominal cramps and pain in the menstrual period. General symptoms such as nausea, vomiting, lumbago, diarrhea and headache are also common. Primary dysmenorrhea refers to menstrual pain that does not depend on the underlying pathology. The kidneys act on the fascia of the psoas muscle. If the psoas muscle does not shorten and grow sufficiently, the kidneys may not move for a certain period of time and may experience ptosis. This causes venous ponding and may cause varicocele in men and primary dysmenorrhea in women. Techniques to be applied directly to the fascia of the psoas muscle can reduce symptoms of dysmenorrhea in women. In the literature review, no studies investigating the effectiveness of a treatment applied directly and only on the psoas muscle on primary dysmenorrhea were not found. This study can set an example for future studies. In our study, myofascial relaxation technique will be applied in women with primary dysmenorrhoea and its effect on pain will be examined.


Eligibility criteria: Inclusion Criteria:

* The age range is 18-30,
* Intense pain compared to visual analog scale in the lower region of the abdomen during or just before the menstruation period (\> 4),
* No pregnancy history,
* Not using drugs for dysmenorrhea symptoms

Exclusion Criteria:

* Not agreeing to participate in the study,
* Endometriosis, ovarian cyst, uterine fibroid, congenital malformation or pelvic inflammation,
* Having a diagnosis of secondary dysmenorrhea

Primary outcomes:
measure: Visual analog scale
timeFrame: 5 seconds
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Esra Pehli̇van
state: Üsküdar
Study officials:
affiliation: Saglik Bilimleri Universitesi
name: Tülay Ülkü Sevim
role: STUDY_CHAIR
References:
Clinical trial NCT01017510: Comparative Study Examining the Effectiveness in Use of a DERMOJET and a Normal Syringe Treatment for Patients With Hair Loss - Alopecia Areata
Official title: Comparative Study Examining the Effectiveness in Use of a DERMOJET and a Normal Syringe Treatment for Patients With Hair Loss - Alopecia Areata
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alopecia Areata
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2009-11-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL

Brief summary: Conventional treatments include the use of steroids applied locally, or injection in to the legion, or oral therapy.

Treatment is determined by the severity of the disease.

Injection in to the legion can be done in two methods

1. Subcutaneous injection syringe Lower
2. Using syringe DERMOJET - a syringe without a needle. So far there are no publications in the medical literature of studies comparing efficacy, safety, convenience of use for doctor-patient, of both methods.


Eligibility criteria: Inclusion Criteria:

1. Subjects over the age of 18
2. Men and women
3. The presence of at least two lesions (centers) in diameter of at least 1.5 cm on both sides of the scalp.
4. Healthy with no diseases that constitute the background against the total label use steroids

Exclusion Criteria:

1. Pregnant women
2. Involvement of more then 50% of the scalp
3. Patients with immunodeficiency-related diseases
4. Patients receiving systemic steroids

Primary outcomes:
measure: Evaluation of lesions will be based on Global assessment of improvement, score of 0-5
timeFrame: 1 year
Secondary outcomes:
measure: Pain level will be evaluated based on a scale of 0-10
timeFrame: 1 year
Other outcomes:
Locations:
city: Rmat Gan
country: Israel
facility: Sheba Medical Center
Study officials:
affiliation: Sheba Medical Center
name: BOAZ AMI-CHI, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05542810: Compare the Effectiveness of Sports Drink and Water as a Solvent in Polyethylene Glycol for Colonoscopy
Official title: A Prospective Randomized Trial to Compare the Effectiveness of Sports Drink and Water as a Solvent in Polyethylene Glycol for Colonoscopy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Bowel Preparation
Lead sponsor: Guangzhou Medical University
Sponsor class: OTHER
First posted: 2022-09-15
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study, 200 patients were enrolled from 2023.1.1 to 2023.12.31, and were randomly divided into intervention and control groups. The intervention group compared the effectiveness of intestinal preparation in the two groups with sports drinks as a polyethylene glycol solvent and water as a polyethylene glycol solvent in the intervention group, and compared adverse reactions, acceptability of solution taste, time of oral laxatives, willingness to repeat the same intestinal preparation or the willingness to recommend the same intestinal preparation to others.


Eligibility criteria: Inclusion Criteria:

Hospitalized patients with gastrointestinal disorders Age 18 to 25 years

Exclusion Criteria:

Those who refuse to drink sports drinks Hypersensitivity to polyethylene glycol pregnant women, patients with suspected intestinal obstruction patients at risk of aspiration or with severe systemic or poorly controlled chronic disease patients with acute or severe disease and coagulation disorders patients with diabetes mellitus patients with a history of abdominal surgery.

Primary outcomes:
measure: A prospective randomized trial to compare the effectiveness of sports drink and water as a solvent in polyethylene glycol for colonoscopy
timeFrame: 1year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05384210: Effect of Milnacipran / Gabapentin in Fibromyalgia
Official title: Effect of Milnacipran Versus Gabapentin or Combination of Both in Fibromyalgia Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fibromyalgia
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2022-05-20
Enrollment: 75
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Gabapentin and milnacipran (MLN) show strong evidence of reduced pain, increased sleep, and improvement in the quality of life in fibromyalgia (FM) patients.

Most FM trials focus primarily on pain reduction with monotherapy. Polypharmacy is commonly used, but supportive evidence is limited.

The gabapentin-MLN combined therapy may be more effective in female patients with FM than their monotherapy.

Detailed description: The aim of the study is to evaluate the analgesic efficacy of gabapentin-MLN as combined or monotherapy on patients with FM.

Eligibility criteria: Inclusion Criteria:

* There are no other criteria rather than age and sex

Exclusion Criteria:

* Patient refusal.
* Pregnancy or breastfeeding.
* Active liver disease
* Renal impairment (creatinine clearance \< 60 mL/min).
* Documented autoimmune disease.
* Severe chronic obstructive pulmonary disease.
* Recent arrhythmia
* Myocardial infarction
* Stroke.
* Uncontrolled hypertension.
* Glaucoma.

Primary outcomes:
measure: Visual analogue scale (VAS) for pain
timeFrame: 3 months
Secondary outcomes:
measure: The Fibromyalgia Impact Questionnaire (FIQ).
timeFrame: 3 months
measure: Leeds Sleep Evaluation Questionnaire
timeFrame: 3 months
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University
state: DK
Study officials:
affiliation: Professor of Anesthesia and Surgical Intensive Care
name: Amr M Yassin, MD
role: STUDY_CHAIR
affiliation: Assistant Professor of Anesthesia and Surgical Intensive Care
name: Eiad A Ramzy, md
role: STUDY_DIRECTOR
References:
Clinical trial NCT02496910: PK Study of YH22162 FDC Compared to Combination of Twynsta and Hygroton
Official title: A Randomized,Open-label,Single Dose,Crossover Clinical Trial to Compare the Safety and Pharmacokinetics of YH22162 in Comparison to the Co-administration of Twynsta and Hygroton in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypertension
Lead sponsor: Yuhan Corporation
Sponsor class: INDUSTRY
First posted: 2015-07-14
Enrollment: 180
Sex: MALE
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: This is a Randomized, open-label, single-dose, 2-treatment, 2-period, 2-sequence crossover design.

Detailed description: This is a 2 by 2 cross-over study to evaluate pharmacokinetics of YH22162 FDC compared to reference twynsta and Hygroton co-administered in two groups enrolling healthy adult male subjects under fasting conditions.

Subjects will be admitted to the clinic in the evening before Day 1. All subjects will receive a single oral dose of YH22162 FDC or twynsta and Hygroton co-administered in the morning on Day 1. All the subjects will remain in the clinical unit until completion of all assessments on Day 2 including collection post-dose PK sample. Subjects will return to the clinic for pharmacokinetic samples at scheduled time. The two treatment periods will be separated by a washout period.

Eligibility criteria: Inclusion Criteria:

1. Healthy male and female with a body mass index(BMI) between 18.5 and 25 kg/m2
2. Who has not suffered from clinically significant disease
3. Provision of signed written informed consent

Exclusion Criteria:

1. History of and clinically significant disease
2. A history of drug abuse or the presence of positive reactions to drugs that have abuse potential in urine screenings for drugs.
3. Administration of other investigational products within 3 months prior to the first dosing.
4. Volunteers considered not eligible for the clinical trial by the investigator (study doctor) due to reasons including laboratory test results, ECGs, or vital signs.
5. Sitting blood pressure meeting the following criteria at screening: 150 ≥ systolic blood pressure ≤100 (mmHg) and 100 ≥ diastolic blood pressure ≤ 60 (mmHg)

Primary outcomes:
measure: Bioequivalence study is based on Cmax and AUC parameters
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Chunju
country: Korea, Republic of
facility: Chonbuk National University Hospital
Study officials:
affiliation: Chonbuk National University Hospital
name: Mingul Kim, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01741610: Fluid Coloading and the Incidence of Hypotension
Official title: Rapid Fluid Administration and the Incidence of Hypotension Induced by Spinal Anaesthesia and Ephedrine Requirement: the Effect of Crystalloid Versus Colloid Coloading
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Complications; Cesarean Section
Anesthesia; Adverse Effect, Spinal and Epidural
Other Fluid Overload
Keywords: Anaesthesia Spinal
Ephedrine
Fluid Therapy
Hypotension
Lead sponsor: Cukurova University
Sponsor class: OTHER
First posted: 2012-12-05
Enrollment: 90
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 46
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: This study was conducted to evaluate the effects of rapid crystalloid (Lactated Ringer's solution) or colloid (hydroxyethyl starch; HES) cohydration with a second intravenous access line on the incidence of hypotension and ephedrine requirement during spinal anaesthesia for caesarean section.

Detailed description: Background: Spinal anaesthesia for caesarean delivery is often associated with hypotension. This study was conducted to evaluate the effects of rapid crystalloid (Lactated Ringer's solution) or colloid (hydroxyethyl starch; HES) cohydration with a second intravenous access line on the incidence of hypotension and ephedrine requirement during spinal anaesthesia for caesarean section.

Methods: We studied 90 women with uncomplicated pregnancies undergoing elective caesarean section under spinal anaesthesia. Intravenous access was established in all with two peripheral intravenous lines, the first being used for the baseline volume infusion. Immediately after induction of spinal anaesthesia, Lactated Ringer's solution (Group L) or HES (Group C) infusions were started at the maximal possible rate via the second line in groups L and C respectively. The third group (Group E) patients received lactated Ringer's solution at a 'keep vein open' rate to maintain the double-blind nature. The incidence of hypotension, ephedrine requirements, total amount of volume and side effects were recorded.

Eligibility criteria: Inclusion Criteria:

* elective caesarean section under spinal anaesthesia

Exclusion Criteria:

* Significant coexisting disease such as; pre-eclampsia and hepato-renal disease,
* Pregnancy preinduced hypertension,
* Being in active labour or requiring emergency caesarean section,
* Any contraindication to regional anaesthesia such as local infection or bleeding disorders.

Primary outcomes:
measure: Rapid fluid administration and the incidence of hypotension induced by spinal anaesthesia and ephedrine requirement: the effect of crystalloid versus colloid coloading
timeFrame: Four Years
Secondary outcomes:
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Hakki Unlugenc
Study officials:
affiliation: Cukurova University
name: Hakki Unlugenc, Prof Dr
role: STUDY_CHAIR
References:
Clinical trial NCT01415310: Quality Register for Geriatric Psychiatry
Official title: Quality Register for Geriatric Psychiatry in Viken Research Network for Geriatric Psychiatry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Geriatric Disorder
Depression
Keywords: Geriatric Psychiatry
Quality register
Quality improvement
Quality control
Research elderly patients with psychiatric disorders
Lead sponsor: Norwegian Centre for Ageing and Health
Sponsor class: OTHER
Collaborators: name: Oslo University Hospital
name: University Hospital, Akershus
name: Diakonhjemmet Hospital
First posted: 2011-08-11
Enrollment: 19000
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients submitted to the geriatric psychiatry units in the Viken Research network for Geriatric Psychiatry

Brief summary: QualGeP (KVALAP) is a quality register in Viken Research network for Geriatric Psychiatry. The objectives of the register are to enhance our knowledge of old persons with severe psychiatric disorders, and to secure an optimal medical evaluation, treatment and care for these patients. The data in the register will be used for quality assurance and for research.

Aims:

* Quality assurance
* Further development of our diagnostic and screening tools
* Contributing to improving the treatment, with and without drugs
* Contributing to improving the dialogue and collaboration between primary healthcare and hospitals

Detailed description: Data collected:

* Demographic data
* Previous and present disorders and use of drugs
* Data from relatives regarding:

  * the patient's cognition
  * psychiatric health
  * behaviour
  * activities of daily living
  * the stress and care burden of relatives
* Tests of cognitive functions
* Methods and duration for treatment
* Transfer to primary healthcare
* Possible readmissions

Eligibility criteria: Inclusion Criteria:

* Patients submitted to geriatric psychiatry units and their relatives who sign the consent form

Exclusion Criteria:

* Patients and relatives who refuse to sign the consent form

Primary outcomes:
measure: Depression and cognition
timeFrame: During admission
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Old Age Psychiatry Unit, Diakonhjemmet Hospital
Study officials:
affiliation: Norwegian Centre for Ageing and Health
name: Knut A. Engedal, professor
role: PRINCIPAL_INVESTIGATOR
References: