louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04071639: Symptomatic Therapy for Patients With Huntington's Disease
Official title: Non-randomized Control Clinical Trial to Evaluate the Efficacy and Safety of Symptomatic Drug Therapy for Mild to Moderate Huntington's Disease Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Huntington Disease
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Case group use Deutetrabenazine，Risperidone，Zoloft and Idebenone(depending on demand and symptom).

Control group use Haloperidol，Risperidone，Zoloft and Idebenone(depending on demand and symptom).
Primary purpose: TREATMENT

Brief summary: Based on the previous symptomatic treatment of Chinese HD patients, this study intends to further optimize the treatment regimen of Chinese HD patients so as to further improve the prognosis of patients.

Detailed description: The purpose of the study is to evaluate symptomatic treatment regimen efficacy based on different disease stages. We previously used symptomatic treatment on Chinese HD patients and most of them got improved both in the motor symptoms and life quality. So this study intends to further optimize the treatment regimen, and set a control group to further evaluate the treatment efficacy.

Eligibility criteria: Inclusion Criteria:

1. Genetic diagnosis of Huntington's disease
2. Symptomatic patients with Huntington's disease
3. Disease duration less than 5 years -

Exclusion Criteria:

(1) Movement disorder due to other definite causes instead of Huntington's disease (2) Severe Lung, kidney or liver disease (3) Neoplastic Disease

-

Primary outcomes:
measure: The Unified Huntington's Disease Rating Scale
timeFrame: Five years
Secondary outcomes:
measure: Brain MRI
timeFrame: Five years
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second Affiliated Hospital,Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: Second affiliated Hospital, Zhejiang University School of Medicine
name: Zhi-Ying Wu
role: STUDY_CHAIR
References:
Clinical trial NCT03017339: Effect of a Functional Exercise Program Associated With Low Level Laser Therapy on Fibromyalgia
Official title: Effect of a Functional Exercise Program Associated With Low Level Laser Therapy on Pain, Functional Capacity and Quality of Life in Individuals With Fibromyalgia: A Double-blind Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: Low Lever Laser Therapy
Exercise Therapy
Chronic Pain
Lead sponsor: Universidade Federal do Rio Grande do Norte
Sponsor class: OTHER
First posted: 2017-01-11
Enrollment: 22
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the effects of a functional exercise program associated with Low Level Laser Therapy (LLLT) on pain, functional capacity and quality of life of individuals with fibromyalgia. Half of participants will receive functional exercise and LLLT, while the other half will receive functional exercise and placebo LLLT.


Eligibility criteria: Inclusion Criteria:

* being female;
* age between 30 and 50 years;
* have an ovulatory cycle;
* height between 1.50m and 1.80m, body mass between 50 and 80 kg and BMI in the range of 18.5 to 29.9 kg / m2;
* present a clinical diagnosis of fibromyalgia, signed by a rheumatologist according to the current criteria of the American College of Rheumatology;
* is at least 6 months without any physical exercise;
* do not present musculoskeletal conditions that prevent them from performing the evaluation and proposed physical activity, except FM;
* not having diabetes mellitus and uncontrolled blood pressure;
* they do not present an inflammatory rheumatic condition or serious cardiovascular and / or pulmonary disease that prevents them from performing the evaluation and the proposed physical activity;
* Not having psychiatric illness or having malignant tumors;
* is not pregnant
* did not present dengue, zika or chikungunya in the last year;
* and finally not to be hypersensitive to light.

Exclusion Criteria:

* not attend for more than two consecutive exercise sessions
* at any time and for any reason expressing an intention to leave the study
* present a health problem that prevents them from continuing to carry out the proposed exercises

Primary outcomes:
measure: Pain assessed by Visual Analogue Scale
timeFrame: Pain assessment two months after the intervention
measure: Pain assessed by Widespread Pain Index
timeFrame: Pain assessment two months after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Natal
country: Brazil
facility: Federal University of Rio Grande do Norte
state: RN
Study officials:
References:
Clinical trial NCT03283839: Consequences of Temporomandibular Disorder on Balance Control
Official title: Consequences of Temporomandibular Disorder on Balance Control
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Temporomandibular Disorder
Pathophysiology
Therapy
Keywords: Temporo-mandibular dysfunction
Balance control
Orientation function
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2017-09-14
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: To evaluate the effects of the temporomandibular disorder (TMD) and its therapeutic care on postural control in somato-sensory and visual sensitization compared to control subjects matched on age, sex and lifestyle.

Parameters will be estimated by measures realized before the therapeutic care of the TMD (T0), then 2, 3 and 5 months after the starting care, both in TMD patients and control subjects. To evaluate also the effects of the TMD and its therapeutic care on balance control in various contexts of multi-sensory stimulation, orientation function, pain and tinnitus.

Detailed description: Primary objective: to evaluate the effects of the temporomandibular disorder (TMD) and its therapeutic care on postural control in somato-sensory and visual sensitization compared to control subjects matched on age, sex and lifestyle.

Eligibility criteria: Inclusion Criteria:

* Patient group: TMD patients, care: occlusal splint therapy, behavioral advices
* Control group: matched with TMD patients (age, sex, lifestyle).

Exclusion Criteria:

* Patient group: treatment generating secondary effects in postural control (psychotrop, antidepressor, antihypertensive drugs); osteoarticular pathologies and recent trauma (\< 4 months); vertigo and dysequilibrium (\< 6 months), whiplash
* Control group: id. and TMD.

Primary outcomes:
measure: Postural control (before care for patients)
timeFrame: At inclusion (before care for patients) (first evaluation)
measure: Postural control (during care for patients)
timeFrame: 2 months after the first evaluation
measure: Postural control (during care for patients)
timeFrame: 3 months after the first evaluation
measure: Postural control (during care for patients)
timeFrame: 5 months after the first evaluation
Secondary outcomes:
measure: Balance function
timeFrame: T0 and 2,3 and 5 months after the first evaluation
measure: Orientation function
timeFrame: T0 and 2,3 and 5 months after the first evaluation
measure: Pain
timeFrame: T0 and 2,3 and 5 months after the first evaluation
measure: Tinnitus
timeFrame: T0 and 2,3 and 5 months after the first evaluation
Other outcomes:
Locations:
city: Nancy
country: France
facility: CHRU de NANCY
Study officials:
References:
Clinical trial NCT03871439: OPEN LABEL, 2-PERIOD STUDY, TO COMPARE BIO-AVAILABILITY OF 2 DIFFERENT FORMULATIONS OF PF-05221304 IN HEALTHY ADULTS
Official title: A PHASE 1, OPEN LABEL, TWO-PERIOD, RANDOMIZED CROSSOVER STUDY TO COMPARE THE PHARMACOKINETICS OF TWO DIFFERENT FORMULATIONS OF PF-05221304 ADMINISTERED ORALLY TO HEALTHY ADULT SUBJECTS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2019-03-12
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to characterize the plasma pharmacokinetics of two formulations of PF 05221304 in healthy adults.


Eligibility criteria: Inclusion Criteria:

* Ages of 18 and 55 years old inclusive
* Body Mass Index (BMI) of \>= 17.5 and \<= 30.4 kg/m2
* Total body weight \> 50 kg (110lb)

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, allergic disease or clinical findings

Primary outcomes:
measure: Plasma PF-05221304 AUClast
timeFrame: Thirteen timepoints between 0-72 Hours
measure: Plasma PF-05221304 Cmax
timeFrame: Thirteen timepoints between 0-72 Hours
Secondary outcomes:
measure: Number of Subjects Experiencing an Adverse Event
timeFrame: Up to 10 weeks from screening
measure: Number of Participants With Clinical Laboratory Abnormalities
timeFrame: Up to 10 weeks from screening
measure: Number of Participants With Categorical Vital Signs Data
timeFrame: Up to 10 weeks from screening
measure: Number of Participants With Abnormal Electrocardiogram (ECG)
timeFrame: Up to 10 weeks from screening
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer New Haven Clinical Research Unit
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00097539: National Cooperative Growth Study (NCGS): A Post-marketing Surveillance Program for Nutropin, Nutropin AQ, Nutropin Depot, and Protropin
Official title: Genentech National Cooperative Growth Study (NCGS) Post-Marketing Surveillance Program For Nutropin AQ® (Somatropin [rDNA Origin] Injection), Nutropin® (Somatropin [rDNA Origin] for Injection), and Protropin® (Somatrem for Injection)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Growth Disorders
Keywords: Pediatric growth disorders
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2004-11-25
Enrollment: 65205
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: Participants initiating therapy with Genentech GH products for the treatment of pediatric growth disorders as determined by their physician and who have consented to participate in the NCGS will be enrolled in the study and will be followed throughout their course of treatment, or until withdrawal from the NCGS.

Brief summary: The purpose of this multicenter, open-label, observational, post-marketing surveillance study is to collect long term safety and efficacy information on growth hormone (GH) products: Protropin (somatrem for injection), Nutropin (somatropin for injection), Nutropin AQ (somatropin for injection), and Nutropin Depot (somatropin for injectable suspension) in the treatment of pediatric growth disorders for which GH is prescribed.


Eligibility criteria: Inclusion Criteria:

* Participants with open epiphyses
* Children of either sex who are treated with Nutropin Depot, Nutropin AQ, Nutropin, or Protropin for the treatment of growth failure
* Participants who are willing to keep follow up appointments throughout the study participation

Exclusion Criteria:

* Participants treated with a non-Genentech GH preparation
* Participants with closed epiphyses
* Participants with active neoplasia

Primary outcomes:
measure: Number of Participants Who Died
timeFrame: From October 1985 to June 2010 (overall approximately 24 years and 9 months)
measure: First Year Annualized Growth Rate
timeFrame: Year 1
measure: Second Year Annualized Growth Rate
timeFrame: Year 2
measure: Third Year Annualized Growth Rate
timeFrame: Year 3
measure: Near Adult Height (NAH)
timeFrame: From October 1985 to June 2010 (overall approximately 24 years and 9 months)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Genentech, Inc.
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT06167148: Gingival Depigmentation Using Diode Laser 940nm Versus 980nm
Official title: Gingival Depigmentation Using Diode Laser 940nm Versus 980nm: A Split-mouth Comparative Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingival Pigmentation
Lead sponsor: University of Alexandria
Sponsor class: OTHER
First posted: 2023-12-12
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: is study aimed to evaluate the effectiveness of two diode lasers of different wave lengths 940nm and 980nm for the treatment of physiologic gingival melanin hyperpigmentation.


Eligibility criteria: Inclusion Criteria:

* Patients of both sexes diagnosed clinically with physiologic gingival pigmentation.
* Pigmentation extending from canine to canine in either upper or lower arch.

Exclusion Criteria:

* Smokers.
* Patients with uncontrolled metabolic disease.
* Immuno-compromised patients.
* Patients with renal disease.
* Patients having coagulation disorders.
* Pregnant and lactating women.
* Evidence about the relation of pigmentation with malignancies.
* History of previous treatment of gingival pigmentation.

Primary outcomes:
measure: Intensity of pigmentation
timeFrame: up to 12 weeks
measure: Extension of pigmentation
timeFrame: up to 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Dentistry, Alexandria University
Study officials:
affiliation: Alexandria University
name: Souzy K Anwar, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Alexandria University
name: Yasmine Y Gaweesh, PhD
role: STUDY_DIRECTOR
affiliation: Alexandria University
name: Nourhan M Aly, MSc
role: STUDY_DIRECTOR
affiliation: Alexandria University
name: Gillan I El-Kimary, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT04826848: Lactate Clearance in Hospital-acquired Pneumonia
Official title: The Prognostic Value of Lactate Clearance in Hospital-acquired Pneumonia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pneumonia
Mortality
Lactate
Prognosis
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients at the age of 18 and over with at least 48 hours of hospitalization within the specified study date range, who were discharged from the hospital within the last 14 days related to this hospitalization, who were re-admitted to the adult emergency department and were diagnosed with pneumonia were included in the study.

Brief summary: There is no clear consensus on the use of pneumonia severity index (PSI) developed for community-acquired pneumonia in hospital-acquired pneumonia cases. In another aspect, PSI is a relatively difficult scoring system that includes many parameters. This study evaluated whether lactate clearance could be used as a mortality marker instead of PSI in hospital-acquired pneumonia. As a result, lactate clearance was lower in the mortal group and when the diagnostic statistics were evaluated, it was seen that the sensitivity and specificity rates were significantly higher. In conclusion, lactate clearance has been evaluated as a strong predictor of mortality in hospital-acquired pneumonia.


Eligibility criteria: Inclusion Criteria:

* 18 and over age, hospital-acquired pneumonia, emergency department admissions

Exclusion Criteria:

* Patients who are pregnant or lactating, under 18 years of age, in the healthcare-associated pneumonia group, had mechanical ventilation at the last hospitalization, whose lactate level could not be studied for any reason at admission and 6th hour, had missing data used in pneumonia severity index calculation and/or who did not accept to participate in the study

Primary outcomes:
measure: Mortality
timeFrame: 28 day
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Yıldırım Beyazıt University, School of Medicine, Department of Emergency Medicine
state: Çankaya
Study officials:
affiliation: Ankara Yıldırım Beyazıt University Faculty of Medicine
name: Alp Şener, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02506348: Comparison of Diclofenac vs. Nepafenac Ophthalmic Drops: Patient Comfort
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Post Surgical Management
Pain Management
Inflamation Management
Lead sponsor: Wolfson Medical Center
Sponsor class: OTHER_GOV
First posted: 2015-07-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: In this study we test Diclofenac and Nepafenac and compared patients experience and comfort following administration of these ophthalmic drops.

Detailed description: In this study we will compare the ocular tolerability between preservative-free Diclofenac and Nepafenac drops. Using a standard comparative scale we will measured discomfort, itching, burning and pain in intervals of 1 sec, 5 sec, 1 min and 5 min post-administration.

The results may aid both doctors and patients in decision regarding the post surgical anti-inflammatory treatment.

Eligibility criteria: Inclusion Criteria:

* patient facing cataract surgery

Exclusion Criteria:

* under 18
* cognitive decline

Primary outcomes:
measure: patient's comfort
timeFrame: 1 min post administration
Secondary outcomes:
measure: patient's comfort
timeFrame: 5 min post administration
Other outcomes:
Locations:
city: Holon
country: Israel
facility: The E.Wolfson Medical Center
Study officials:
References:
Clinical trial NCT05084248: Vitamin D Deficiency in Adults Following a Major Burn Injury
Official title: Vitamin D Deficiency in Adults Following a Major Burn Injury
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Vitamin D Deficiency
Burns
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2021-10-19
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a single site double blind randomized controlled trial of replacing Vitamin D for Vitamin D-deficient burn patients at a current recommended dose (400 IU daily) versus a higher dose (4000 IU daily). Capsules will be made in a compounding pharmacy and will look identical.

Randomized controlled trial. People who meet the selection criteria will be randomized to either low or high dosage of Vitamin D. Treatment arm is high dose Vitamin D (4000 IU), and control is low dose Vitamin D (400 IU). Main outcome variables include PROMIS-29 measures of physical health, mental health and social health, the Veterans RAND 12 Item Health Survey (VR-12), and the 4-D Itch Scale. Secondary outcome variables include subject demographics, injury demographics and characteristics.


Eligibility criteria: Inclusion Criteria:

1. Adults, 18 years of age or older, who have completed 6 months from time of their burn injury
2. ≥ 10% TBSA, ≥ 65 years of age and Burn Surgery for Wound Closure
3. ≥ 20% TBSA, 18 - 64 of age and Burn Surgery for Wound Closure
4. Electrical high voltage / lightning and Burn Surgery for Wound Closure
5. Hand burn and/or face burn, and/or feet burn and Burn Surgery for Wound Closure
6. May speak English or Spanish
7. Vit. D deficiency

Exclusion Criteria:

1. Patients with parathyroid disease, severe liver dysfunction, sever kidney dysfunction, which are not caused by the burn injury
2. Patients with malignant tumors
3. Patients not meeting the inclusion criteria

Primary outcomes:
measure: Patient-Reported Outcomes Measurement Information System-29
timeFrame: 6 months and 12 months
Secondary outcomes:
measure: Demographics
timeFrame: 6 months
measure: Patient-Reported Outcomes Measurement Information System-Global
timeFrame: 6 months and 12 months
measure: Patient-Reported Outcomes Measurement Information System-Itch
timeFrame: 6 months and 12 months
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Parkland Health and Hospital Systems
state: Texas
Study officials:
affiliation: UT Southwestern
name: Maria Pia Kabamalan
role: STUDY_CHAIR
References:
Clinical trial NCT02904148: Passive Mobilisation of Region of Shoulder Joints for Hemiplegic Patient
Official title: Measurement of the Analgesic Efficacy of Shoulder Mobilization in Hemiplegic Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Hemiplegia
Lead sponsor: Centre Hospitalier Universitaire de la Réunion
Sponsor class: OTHER
First posted: 2016-09-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Hemiplegia is a high prevalence pathology with 1 per 1000 habitants in France. One of these complications is shoulder pain which affects about 35 to 70% of cases. The medical care of this complication is critical because it affects the patient's quality of life and also hinders participation in rehabilitation sessions slowing the recovery of independence in activities of daily living.

Literature confirmed the involvement of the scapula in the hemiplegic shoulder pain with his attitude pronounced lateral rotation. But no data to confirm that passive mobilization reduce shoulder pain.

Because no data available to permit us to determine the sample size we set-up this preliminary study to check if efficiency found in these preliminary data are consistent with an estimable real efficacy in a randomized trial feasible.


Eligibility criteria: Inclusion Criteria:

* Hospitalized in Physical Medicine and Rehabilitation at Centre Hospitalier Universitaire Réunion (Site of Le Tampon)
* Having made a cerebrovascular accident between 30 and 3 days before inclusion
* with pain in the upper limb whose score with visual analogue scale is greater than or equal to 20 mm
* able to understand the question: "Do you have arm pain?"

Exclusion Criteria:

* with visual analogue scale score lower than 20 mm at the inclusion
* with aphasia of comprehension
* with medical contraindication for passive shoulder mobilisation (Shoulder fracture, dislocation,...)
* opposing to any mobilization
* with shoulder pathology previously known
* history of cerebrovascular accident prior 30 days before inclusion

Primary outcomes:
measure: Pain evaluation with visual analogic scale
timeFrame: Change of pain evaluation between Day 0 and Day 45
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: CHU de La Réunion
name: Andre Muller, MD
role: PRINCIPAL_INVESTIGATOR
References: