louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01977170: Safety of Hib Vaccine (Bio Farma)
Official title: Phase 1 Study of Hib Vaccine (Bio Farma)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Adults
Hib vaccines
Immunogenicity
Safety
Lead sponsor: PT Bio Farma
Sponsor class: INDUSTRY
First posted: 2013-11-06
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The objective of this study was to know the safety of Hib/PRP-T vaccine and immediate reactions within the first 30 minutes after injection.

Detailed description: This trial was an open-label study, no randomization, and no placebo or control group. Total 25 young healthy adult (volunteers) followed this trial. The safety was assessed within 24 hours, 48 hours, 72 hours, and 28 days after injection.

Eligibility criteria: Inclusion Criteria:

* Adult (age 18 - 40 years old)
* Provision of written informed consent
* Good health according to the clinical investigator
* Willingness and ability to adhere to the regimen of the study

Exclusion Criteria:

* Known not enrolled in other study
* Pregnancy or lactation
* Known or suspected allergy to any of the vaccine component (by medical history)
* History of unusual reaction to any previous vaccination
* Known or suspected immune deficiency, or use of medication that may influence the immune system
* Prior respiratory infection
* Other vaccination during the study, or one week before (inactivated vaccine) or one month (live vaccine) before the study
* Acute febrile illness (temperature \> 37.5 Celsius)
* Present evidence of serious diseases demanding medical treatment
* Any significant congenital or chronic disorder

Primary outcomes:
measure: Incidence rate of adverse event of Hib vaccine (Bio Farma)
timeFrame: 30 minutes
Secondary outcomes:
measure: To evaluate the antibody function serum using serum bactericidal activities test
timeFrame: 28 days
measure: Incidence rate of adverse event of Hib vaccine (Bio Farma)
timeFrame: 28 hours, 48 hours, 72 hours, 28 days
Other outcomes:
Locations:
city: Bandung
country: Indonesia
facility: Hasan Sadikin Hospital
state: West Java
Study officials:
affiliation: Faculty of Medicine UNPAD
name: Kusnandi Rusmil, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05034770: Effectiveness of Major Ozone Autohemotherapy in the Treatment of Fibromyalgia Syndrome
Official title: Effectiveness of Major Ozone Autohemotherapy in the Treatment of Fibromyalgia Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fibromyalgia Syndrome
Lead sponsor: Kocaeli University
Sponsor class: OTHER
First posted: 2021-09-05
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * 18-60 years ranged, male and female patients
* diagnosed fibromyalgia syndrome witc ACR 1990,2010 criterias,
* volunteers that gave consent,
* treated with major ozone autohemotherapy (10 sessions)

Brief summary: Patients who were admitted to the Physical Medicine and Rehabilitation (PMR) outpatient clinic of our hospital between January 2017 and December 2020 and were treated with Major ozone autohemotherapy with a diagnosis of Fibromyalgia syndrome will include to the study. Visual anolog scale (VAS), Fibromyalgia Impact Questionnare (FIQ) and Short Form Health Survey-36 (SF-36) scores of the patients before and after treatment were recorded. Statistical analysis of these outcome scores will be made.


Eligibility criteria: Exclusion Criteria:

* has pregnancy,
* has primary romatological disease,
* has primary psychiatric disease
* \<18, \>60 years old patients

Primary outcomes:
measure: Short Form Health Survey-36
timeFrame: 20 minutes
Secondary outcomes:
measure: Fibromyalgia Impact Questionnare
timeFrame: 5 minutes
Other outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: 10 seconds
Locations:
city: Kocaeli
country: Turkey
facility: Private Medar Hospital
Study officials:
References:
Clinical trial NCT00001070: The Safety and Effectiveness of Different Doses of Vitamin C in HIV-Infected Patients
Official title: A Dose Escalation Study to Evaluate Tolerance and Antiviral Effect of Oral Vitamin C in Two Groups of HIV-Infected Adults
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: HIV Infections
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
First posted: 2001-08-31
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: This is a study to evaluate the tolerance and antiviral effect of oral vitamin C in HIV-infected.


Eligibility criteria: Not applicable - Study withdrawn since 04/23/1996

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01016470: Efficacy of Nutritional Supplement VIUSID/ALZER in Patients With Parkinson's Disease
Official title: Efficacy of Nutritional Supplement VIUSID/ALZER in Patients With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Parkinson's Disease
Lead sponsor: Catalysis SL
Sponsor class: INDUSTRY
First posted: 2009-11-19
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate whether Viusid/Alzer Nutritional supplements, could improve the progression disease, in patients with Parkinson's Disease (PD).

Detailed description: Periodical measures of the clinical features with UPDRS will be done at the beginning, each three months until two years. Each group will be compare to evaluate.

Eligibility criteria: Inclusion Criteria:

* Patients with clinical of PD, with the criteria of Brain Bank of London with early stage.
* Informed consent.

Exclusion Criteria:

* Presence of another disease not well controlled.
* Patient with atypical features.
* Patient with advanced Parkinson's disease.

Primary outcomes:
measure: Periodical measures of the clinical features with Unified Parkinson Disease Rating Scale (UPDRS) will be done at the beginning, every three months until one year (end of the treatment)
timeFrame: one year
Secondary outcomes:
measure: Hoehn-Yarh will be done at the beginning, every three months until one year (end of the treatment)
timeFrame: one year
measure: Dosage levodopa will be done at the beginning, every three months until one year (end of the treatment)
timeFrame: one year
Other outcomes:
Locations:
city: Havana City
country: Cuba
facility: "Salvador Allende Hospital"
state: Havana
Study officials:
affiliation: "Salvador Allende" Hospital
name: Jose Luis Guiroud, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01399970: Use of Mobile Teledermatology in the Care of Acne Patients
Official title: Use of Mobile Teledermatology in the Care of Acne Patients - A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acne
Keywords: Mobile Teledermatology
Telemedicine
Acne
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
Collaborators: name: National Bank of Austria
First posted: 2011-07-22
Enrollment: 69
Sex: ALL
Minimum age (years): 12
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of the present study is to determine whether a mobile teledermatology care model can achieve better clinical outcomes as compared to conventional, outpatient care for the management of severe acne treated with isotretinoin.

The superiority of mobile care in comparison to conventional, outpatient care will be investigated regarding

1. effectiveness: Global evaluation Acne (GEA) score -response at week 24
2. safety: drop out rates and medication side effects
3. overall patient satisfaction with acne care and therapy
4. overall physician satisfaction with mobile acne care


Eligibility criteria: Inclusion Criteria:

Female or male, aged 12 to 30 years

* with facial acne
* requiring systemic isotretinoin treatment (GEA-Score: 3-5)
* with basic handy skills
* with a signed consent form

Exclusion Criteria:

* Pregnancy or lactation period
* Withdrawal of informed consent
* Non-compliance, failure to comply with protocol requirements

Primary outcomes:
measure: Global evaluation Acne score (GEA)
timeFrame: week 24
Secondary outcomes:
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Department of Dermatology, Medical University of Graz
Study officials:
affiliation: Department of Dermatology, Medical University of Graz
name: Rainer Hofmann-Wellenhof, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01125670: A Pharmacokinetic Study to Investigate the Effect of Food on the Pharmacokinetics of YM150 Tablet
Official title: Pharmacokinetic Study of YM150 - A Pharmacokinetic Study to Investigate the Effect of Food on the Pharmacokinetics of YM150 Tablet-
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Pharmacokinetics of YM150
Keywords: YM150
Food effect
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2010-05-18
Enrollment: 24
Sex: MALE
Minimum age (years): 20
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: This study is to evaluate the effect of food on the pharmacokinetics of YM150 in healthy make adult subjects.

Detailed description: To evaluate the effect of food on the pharmacokinetics of YM150 in healthy non-elderly adult male subjects using a 2×2 crossover design. Also, to evaluate the safety of YM150.

Eligibility criteria: Inclusion Criteria:

* Body weight: ≥50.0 kg, \<80.0 kg
* BMI: ≥17.6, \<26.4
* Healthy, as judged by the investigator or sub-investigator based on the results of physical examinations and lab tests

Exclusion Criteria:

* Received any investigational drugs within 120 days before the study
* Donated 400 mL of whole blood within 90 days, 200 mL of whole blood within 30 days, or blood components within 14 days before the study
* Received medication within 7 days before the study
* A deviation from the assessment criteria of physical examinations or laboratory tests
* A deviation from the normal reference range of coagulation test \[PT (INR) or aPTT\]
* History of drug allergies
* Upper gastrointestinal disease within 7 days before the study
* Concurrent or previous hepatic, gastrointestinal, heart, cerebrovascular or respiratory diseases
* Concurrent or previous malignant tumor
* Previous treatment with YM150

Primary outcomes:
measure: Plasma concentration of YM150 and its metabolites measured by blood samples
timeFrame: for 3 days after drug administration
Secondary outcomes:
measure: Safety assessed by AEs, vital signs, 12-lead ECG and lab tests
timeFrame: for 3 days after drug administration
Other outcomes:
Locations:
city: Kyushu
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Use Central Contact
role: STUDY_CHAIR
References:
Clinical trial NCT04421170: Efficacy of Smartphone App for Smoking Cessation in China
Official title: Efficacy of Cognitive Behavioral Therapy-based Smartphone App for Smoking Cessation in China: a Study Protocol of a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cigarette Smoking
Smartphone App-based Smoking Cessation
Lead sponsor: Sir Run Run Shaw Hospital
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 1289
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the efficacy of cognitive behavioral therapy (CBT)-based cigarette smoking cessation smartphone app for treatment seeking smokers in China.


Eligibility criteria: Inclusion Criteria:

1. Cigarette smokers (smoked more than 100 cigarettes in their lifetime, and currently smoke five or more cigarettes a day)
2. 25 years of age or older
3. Being able to read and write in Chinese
4. Owning a smartphone
5. Have experience of using apps
6. Expressing an interest in quitting smoking within the next month
7. Willing to provide informed consent to participate in the study

Exclusion Criteria:

1. Nonsmokers
2. Only use electronic cigarettes
3. Smokers without attempts to quit smoking
4. Participants with severe mental illness
5. Participants who had already started their quit attempt or using any smoking cessation treatment at the time of registration
6. Unable to use smartphone and apps
7. Unable to read and write in Chinese

Primary outcomes:
measure: Biologically verified continuously smoking abstinence at week 26
timeFrame: 26 weeks
Secondary outcomes:
measure: 7-day point prevalence smoking abstinence
timeFrame: 26 weeks
measure: Self-reported continuous smoking abstinence
timeFrame: 26 weeks
measure: Reductions in number of cigarettes smoked per day
timeFrame: 26 weeks
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Yanhui Liao
state: Zhejiang
Study officials:
affiliation: Department of Psychiatry, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
name: Yanhui Liao, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Liao Y, Tang J. Efficacy of cognitive behavioural therapy-based smartphone app for smoking cessation in China: a study protocol of a randomised controlled trial. BMJ Open. 2021 Jan 13;11(1):e041985. doi: 10.1136/bmjopen-2020-041985.
Clinical trial NCT00907270: Supplementation With Vitamin D Improves Leptin Resistance
Official title: Effect of Vitamin D Supplementation on Leptin Resistance, Hunger, Body Weight and Resting Energy Expenditure in Obese Women.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Overweight
Obesity
Lead sponsor: Mexican National Institute of Public Health
Sponsor class: OTHER_GOV
First posted: 2009-05-22
Enrollment: 50
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Participants will be randomly assigned in one of two groups. Group A: oral supplementation with 4,000 IU of vitamin D (cholecalciferol). Group B: oral supplementation with 400 IU of vitamin D (cholecalciferol). Both treatments will be consumed daily for 6 months.

Outcomes will be evaluated at baseline, three and six months. Variables related to leptin resistance will be evaluated.

The main hypothesis is that vitamin D will diminish leptin resistance in overweight and obese women. If the hypothesis is confirmed, women will show a reduction in the Resting energy expenditure: serum Leptin ratio (REE: Leptin ratio), as well as a reduction of hunger, body weight, body and abdominal fat and an increase in resting energy expenditure.

Detailed description: Study subjects will get dietary advice and physical activity counseling. At the end of the study, participants with suboptimal vitamin D levels (\<80 nmol/L 25-OH-D) will receive treatment to normalize their vitamin D status.

Variables related to leptin resistance like resting metabolic expenditure, hunger, body weight and human body fat will be assessed. Outcomes will include, glucose, insulin, C-reactive protein, inflammatory interleukins (IL-6 \& TNF-α) and non-inflammatory interleukins (IL-10 \& TGF-β-1).

Eligibility criteria: Inclusion Criteria:

* BMI: 25-29.9
* Serum vitamin D levels: 20-80 nmol/L (25-OH-D)

Exclusion Criteria:

* Liver disease
* Kidney disease
* Diabetes mellitus
* Malignity
* Any kind of hormonal disorder
* Medication that modify hunger/satiety answer and those medications that alter -the glucose/insulin metabolism
* Subjects with diet treatment to lose weight

Primary outcomes:
measure: Evaluation of leptin resistance: (resting energy expenditure: leptin ratio) before and after (3 and 6 months) supplementation with vitamin D3 (cholecalciferol) 4,000 or 400 IU/day.
timeFrame: basal, third and sixth month
Secondary outcomes:
measure: Effect of vitamin D supplementation (25-OH-D): hunger, body weight, energy intake, resting energy expenditure, and body fat, improvement on low intensity chronic inflammation, SOCS-3 expression and JAK2/STAT3 signal.
timeFrame: Basal, third and sixth month
Other outcomes:
Locations:
city: Cuernavaca
country: Mexico
facility: National Institute of Social Insurance
state: Morelos
Study officials:
affiliation: National Institute of public Health
name: Mario Flores-Aldana, MsC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02966470: Hand Grip Strength as a Marker of Frailty in Surgical Patients
Official title: Hand Grip Strength as a Marker of Frailty in Surgical Patients
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Frailty
Keywords: surgical outcomes
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2016-11-17
Enrollment: 52
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: General surgery patients admitted to the Section of General Surgery, Trauma, and Surgical Critical Care who are over the age of 60.

Brief summary: This study aims to assess if grip strength can be used as a single, objective surrogate of frailty assessment in the surgical population.

Detailed description: Frailty is associated with worse outcomes. Current screening surveys are cumbersome, most containing multiple components. For frail patients particularly, it can be difficult to ascertain all the information requested. There is a need for a simple, one step, objective screening measure of frailty. There is some evidence in the medicine patients that grip strength may be related to frailty, but no such information is available for surgical patients.

Eligibility criteria: Inclusion Criteria:

* General surgery patient admitted to the Section of General Surgery, Trauma, and Surgical Critical Care
* Age \>60

Exclusion Criteria:

* Pregnancy
* Untreated or metastatic malignancy
* Prisoners

Primary outcomes:
measure: linear regression of grip strength to frailty survey score
timeFrame: 10 minutes at the time of admission
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale School of Medicine
state: Connecticut
Study officials:
affiliation: Yale University
name: Bishwajit Bhattacharya, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05394870: Clinical and Electrophysiological Evaluation of the Effectiveness for Manual Lymphatic Drainage
Official title: Clinical and Electrophysiological Evaluation of the Effectiveness of Manual Lymphatic Drainage in Patients With Mild-to-moderate Carpal Tunnel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carpal Tunnel Syndrome
Electrophysical Evaluation
Manual Lymphatic Drainage
Lead sponsor: Selcuk University
Sponsor class: OTHER
First posted: 2022-05-27
Enrollment: 34
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: When the other usage areas of the manual lymphatic drainage technique in the literature, except for the treatment of lymphedema, were examined recently, it was seen that it was also applied in orthopedic and neurological cases in a limited number of studies. The aim of our study is to investigate the effectiveness of manual lymphatic drainage on clinical and electrophysiological findings in carpal tunnel syndrome


Eligibility criteria: Inclusion Criteria:

* Diagnosis of mild to moderate carpal tunnel syndrome on electrodiagnostic examination
* Being between 20-55 years old
* Volunteering to participate in the treatment to be given

Exclusion Criteria:

* Have a systemic inflammatory disease
* Having any disease that may cause polyneuropathy, such as diabetes mellitus
* Cognitive impairment
* Receiving psychotherapy
* Having a pacemaker
* illiterate
* Having a disease affecting the central nervous system
* Having a hearing problem
* Any skin disease that would contraindicate manual lymphatic drainage
* Arterial or venous circulation disorder that would contraindicate manual lymphatic drainage

Primary outcomes:
measure: pressure pain threshold
timeFrame: 15 minutes
measure: Boston Carpal Tunnel Questionnaire (BCTQ)
timeFrame: 10 minutes
measure: Electrodiagnostic evaluation
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Kütahya
country: Turkey
facility: Kutahya Health Science University
state: Centrum
Study officials:
References:
Clinical trial NCT00926770: Cerebral Near Infrared Spectroscopy During Blood Sampling From a Peripheral Artery Catheter in Preterm Infants
Official title: Measurement of Cerebral Oxygenation With Near Infrared Spectroscopy During Blood Sampling From a Peripheral Artery Catheter in Preterm Infants With Gestational Age <37+0
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cerebral Oxygenation
Cerebral Blood Flow
Prematurity
Lead sponsor: University of Cologne
Sponsor class: OTHER
First posted: 2009-06-24
Enrollment: 20
Sex: ALL
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Preterm infants (Gestational Age \<37+0)

Brief summary: Preterm infants often need peripheral artery catheters for invasive blood pressure recording and to facilitate blood sampling. Near infrared spectroscopy is a method to evaluate cerebral oxygenation and as well as cerebral blood flow. Sampling procedures with identical sampling volumes are performed at a short (40 seconds) and a long (70 seconds) time intervall while changes of cerebral oxygenation are measured. The investigators hypothesise that slower sampling decrease changes in cerebral blood flow.


Eligibility criteria: Inclusion Criteria:

* Preterm infant (Gestational Age \<37+0)
* Peripheral arterial catheter (ulnary or radial artery)

Exclusion Criteria:

* Complex organ malformation

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: University of Cologne, NICU
state: NRW
Study officials:
References: