louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05709340: PNF Exercises on Treatment of Temporomandibular Dysfunction
Official title: Efficacy of PNF Exercises on Treatment of Temporomandibular Dysfunction in Patients With Forward Head Posture: A Double-blind, Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Temporomandibular Joint Disorders
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-02-02
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Temporomandibular joint dysfunction (TMJD) is an important health problem that occurs approximately in 22 to 35 percent of adults, different physiotherapy methods are reported as treatment options for management of TMJD. Although that, there is no previous studies about the efficacy of PNF exercises in treatment of TMJD in patients with forward head posture. So, the purpose of the present double-blind, randomized, controlled trial is to investigate the efficacy of PNF exercises in treatment of TMJD in patients with forward head posture.


Eligibility criteria: Inclusion criteria:

* Patients of both genders of age between 20-40 years
* having symptoms of TMD for at least six weeks duration established by an expert physician or orthopaedician
* having forward head posture with CVA \< 53
* pain over TMJ between 3 to 6 on NPRS
* mouth opening \< 25mm.

Exclusion criteria:

Patients will be excluded if they exhibited any of the following criteria:

* TMJ fracture undergone any surgical procedure for TMJ
* Fracture surrounding TMJ
* Dislocation or subluxation of TMJ
* systemic generalized joint diseases, such as rheumatoid arthritis, and osteoporosis, congenital diseases, or facial paralysis
* recently any dental treatment is taken or surgery over TMJ
* hematological cervical disorders which may affect the jaw
* Neurological deficits e.g. Bells palsy, Trigeminal neuralgia.
* Recent infections (within the last six months) affecting the head and neck e.g. bone infections, meningitis, encephalitis, malaria, ear infection
* Participants who were using any functional appliances e.g. dentures, braces, bite appliances which had been adjusted or fitted in the last 12 weeks prior to the commencement of this study
* DDwR, DDwoR
* Patients were excluded from the study if they were receiving any other form of treatment for their TMJ dysfunction.

Primary outcomes:
measure: Pressure Pain Threshold
timeFrame: change from base line at 6 weeks.
Secondary outcomes:
measure: ROM assessment
timeFrame: change from base line at 6 weeks.
measure: Temporomandibular Disorder Disability Questionnaire
timeFrame: change from base line at 6 weeks.
measure: Numerical Rating Scale (NRS)
timeFrame: change from baseline at 6 weeks.
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: marwa S saleh
Study officials:
References:
Clinical trial NCT05379140: Use Therapeutic Chinese Massage to Treat Peripheral Neuropathy in People With HIV
Official title: Using Therapeutic Chinese Massage to Treat Peripheral Neuropathy in People With Human Immunodeficiency Virus: A Randomized Control Trial Pilot Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Peripheral Neuropathy
Lead sponsor: University of Houston Downtown
Sponsor class: OTHER
First posted: 2022-05-18
Enrollment: 24
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: Background: Peripheral neuropathy (PN) occurs in half of the people with human immunodeficiency virus (PHIV). Currently, there is no Food and Drug Administration-approved treatment for HIV-related PN. Only half of PHIV who take medications report a significant reduction in pain. Therapeutic Chinese Massage, structured palpations or movements of soft tissues of the body, is a promising non-harmful, and non-costly intervention that can potentially alleviate or even treat PN but relevant research is limited.

Method: Investigators conducted a single centered, two-arm, single-blinded randomized controlled trial pilot study to examine if a series of three weekly 25-minute therapeutic Chinese massage sessions by a therapist of therapeutic Chinese massage, compared with placebo massage, could reduce PN-related pain and improve lower extremity functioning in PHIV. Twenty PHIV were recruited from the AIDS Foundation Houston, Inc in Texas. Pain, lower extremity functioning, and health-related quality of life were assessed for both groups prior to and post-massage.


Eligibility criteria: Inclusion Criteria:

Clinical diagnosis of HIV and peripheral neuropathy have self-reported PN-related pain in lower extremity are not taking any kind of medications to alleviate PN symptoms age at least 18 years old not pregnant or lactating

Exclusion Criteria:

have received any kind of massage in the past three months Can not give informed consent

Primary outcomes:
measure: Feasibility of this study design
timeFrame: through study completion, an average of one year
Secondary outcomes:
measure: Change in Peripheral neuropathy related pain at the third visit
timeFrame: Through study completion, an average of one year
measure: Change in health related quality of life at the third visit
timeFrame: Through study completion, an average of one year
measure: Change in lower extremity functioning at the third visit
timeFrame: Through study completion, an average of one year
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Houston-Downtown
state: Texas
Study officials:
References:
Clinical trial NCT03017040: In Vivo Kinematics of Scapolunate Interosseous Ligament Injuries
Official title: In Vivo Kinematics of Scapolunate Interosseous Ligament Injuries
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Scapholunate Ligament Tear
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2017-01-11
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The investigators hypothesize that there is no relationship between in vivo kinematic abnormalities and patient-rated outcomes for scapholunate interosseous ligament injuries (SLIL)

The secondary null hypotheses are that: There are no kinematic differences between subjects with unilateral, symptomatic, full thickness scapholunate ligament tears in comparison to the contralateral wrist without scapholunate ligament injury.

The investigators aim to answer to the below questions:

* What are baseline validated outcomes for subjects with SLIL injury?
* What are baseline physical measures (range of motion, Jamar Dynamometry)?

Detailed description: In vivo kinematics of the normal wrist has been studied previously, but few studies have characterized the wrist with a SLIL injury. There are few studies evaluating validated patient-rated outcomes for patients with SLIL injury. The goal of this study would be to evaluate to what degree kinematic abnormalities affect patient-rated outcomes.

Eligibility criteria: Inclusion Criteria:

* All patients with a unilateral full thickness scapholunate ligament tear diagnosed by radiographs or advanced imaging

Exclusion Criteria:

* Patients with a partial thickness scapholunate ligament tear
* Patients with radiographic arthrosis
* Patients with prior wrist injury
* Pregnant women

Primary outcomes:
measure: Patient Rated Wrist Evaluation (PRWE)
timeFrame: at enrollment
measure: SF-12 Patient Questionnaire
timeFrame: at enrollment
measure: DASH Questionnaire
timeFrame: at enrollment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Massachusetts General Hospital
name: Neal Chen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00319540: RCT of Psychoeducational Program of Depression
Official title: A Randomized Controlled Trial of a Psychoeducational Group Program for Unipolar Depression in Adults in Norway
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Unipolar Depression
Keywords: Depression
psychoeducation
RCT
primary health services
Lead sponsor: Norwegian Institute of Public Health
Sponsor class: OTHER_GOV
First posted: 2006-04-27
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to test the efficacy of a psychoeducational group program on unipolar depression

Detailed description: Unipolar depression is a common disorder which may be treated by drugs or psychological intervention. Many patients prefer psychological treatment, but there is a lack of professional skills and methods for effectively dealing with this in the primary health services,where most of the depressed patients are seen.For this reason it is of great importance to develop and test psychological methods which may be applied in the primary health services, as well as in the specialized psychiatric services.In the present study a psychoeducational group method is tested, with trained psychiatric nurses as the most common group leaders.

Comparison: People with unipolar depression receiving "treatment as usual"

Eligibility criteria: Inclusion Criteria:Unipolar depression -

Exclusion Criteria:Psychosis, other psychiatric disorders, subclinical depression, suicidal ideation, learning disabilities

-

Primary outcomes:
measure: BeckDepression Inventory : A questionnaire with 23 items to measure symptoms of depression
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Norwegian Institute of Public Health
Study officials:
affiliation: Norwegian Institute of Public Health
name: Odd Steffen Dalgard, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ducasse D, Courtet P, Seneque M, Genty C, Picot MC, Schwan R, Olie E. Effectiveness of the first French psychoeducational program on unipolar depression: study protocol for a randomized controlled trial. BMC Psychiatry. 2015 Nov 17;15:294. doi: 10.1186/s12888-015-0667-7.
Clinical trial NCT00004940: Phase III Study of L-Cysteine in Patients With Erythropoietic Protoporphyria
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Erythropoietic Protoporphyria
Keywords: erythropoietic protoporphyria
inborn errors of metabolism
porphyria
rare disease
Lead sponsor: FDA Office of Orphan Products Development
Sponsor class: FED
First posted: 2000-02-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: OBJECTIVES:

I. Determine the long-term efficacy and safety of L-cysteine in the prevention photosensitivity in patients with erythropoietic protoporphyria.

Detailed description: PROTOCOL OUTLINE: This is a phase III study, lasting 3 years; 1996-1999. Patients are administered L-cysteine orally twice daily, 2 capsules with breakfast and 2 with lunch.

Patients fill in questionnaires and diary sheets about their reaction to sunlight exposure, and have blood tested 3 times a year.

Completion date provided represents the completion date of the grant per OOPD records

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Erythropoietic protoporphyria RBC protoporphyrin greater than 50 micrograms/100 dL

--Prior/Concurrent Therapy--

At least 3 months since prior betacarotene or L-cysteine

No concurrent betacarotene

--Patient Characteristics--

* Fertile female patients must use effective contraception for duration of trial and for 3 weeks thereafter
* Not pregnant or nursing

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Brigham and Women's Hospital
name: Micheline Mary Mathews-Roth
role: STUDY_CHAIR
References:
Clinical trial NCT06865040: Perioperative Inhaled Therapy in Carcinological Thoracic Surgery in Patients at High Risk of Postoperative Pulmonary Complications
Official title: Perioperative Inhaled Therapy in Carcinological Thoracic Surgery in Patients at High Risk of Postoperative Pulmonary Complications
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Thoracic Surgery
Postoperative Pulmonary Complications (PPCs)
Keywords: Thoracic surgery
postoperative pulmonary complications
Inhaled therapy
bronchodilators
B2 mimetics
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2025-03-07
Enrollment: 266
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of the study is to evaluate, in a clinical trial, the efficacy of peri operative administration of long-acting inhaled ß-2 mimetics on the occurrence of postoperative pulmonary complications


Eligibility criteria: Inclusion Criteria:

* Adult (\>18 years)
* Lung cancer eligible for surgical management by lung resection (non-small cell lung carcinoma = NSCLC) by any route
* Naïve to long-term inhaled bronchodilator therapy
* High risk of post-operative pulmonary complications (Pre-operative FEV1 \< 80%)

Exclusion Criteria:

* Patient refusal
* Pregnancy
* Emergency surgery
* Patient with a physiological status of WHO IV or ASA ≥ IV
* Asthma
* Patients treated with long-acting bronchodilators
* Severe heart failure (NYHA IV), unstable ischaemic heart disease (angina or recent infarction \< 3 months), obstructive hypertrophic cardiomyopathy, subvalvular aortic stenosis, severe uncontrolled hypertension Recent stroke \< 3 months
* High-grade unresponsive conductive disorders or unstable arrhythmia
* Thyrotoxicosis, pheochromocytoma
* Unbalanced diabetes
* Hypersensitivity to ß-2 mimetics or lactose
* Current participation in a trial of another drug therapy

Primary outcomes:
measure: Number of postoperative pulmonary complication
timeFrame: day 7
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHRU Amiens
Study officials:
References:
Clinical trial NCT04917640: Registry for Accelerated Partial Breast Irradiation With (SBRT) or (IMRT)
Official title: Accelerated Partial Breast Irradiation (PBI) With Stereotactic Body Radiation Therapy (SBRT) or Intensity Modulated Radiation Therapy (IMRT)
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Breast Cancer
Lead sponsor: GenesisCare USA
Sponsor class: OTHER
First posted: 2021-06-08
Enrollment: 0
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with greater than or equal to 50 years old and who have been diagnosed with Low to intermediate DCIS

Brief summary: This is a registry study that will be used to evaluate external beam radiation therapy methods for the accelerated treatment of breast cancer. Patients are being asked to take part in this registry because they have breast cancer and desire treatment with accelerated partial breast irradiation to be delivered by external beam methods.


Eligibility criteria: Inclusion Criteria:

* Greater than or equal to 50 years old Low to intermediate DCIS Tumor size \< or = to 2cm

Exclusion Criteria:

* BRCA positive Lobular histology Angiolymphatic invasion

Primary outcomes:
measure: Number of participants with treatment and toxicity-related adverse events as assessed by CTCAE v4.0".
timeFrame: Through study completion, an average of 12 months
Secondary outcomes:
measure: Number of participants with ipsilateral breast recurrence
timeFrame: Through study completion, an average of 12 months
Other outcomes:
Locations:
city: Stuart
country: United States
facility: GenesisCare USA
state: Florida
Study officials:
affiliation: Fundacion GenesisCare
name: Sharon Salenius, MPH
role: STUDY_DIRECTOR
References:
Clinical trial NCT05780840: Protection Against Visible Light by Dihydroxyacetone in Erythropoietic Protoporphyria
Official title: Protection Against Visible Light by Dihydroxyacetone in Erythropoietic Protoporphyria
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Erythropoietic Protoporphyria
Keywords: Dihydroxyaceton
Erythropoietic protoporphyria
Light protection
Protoporphyrin IX
Self-tanning
Skin
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2023-03-23
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: What is the visible light protective effect of dihydroxyacetone in individuals with erythropoietic protoporphyria? This will be tested in this randomized blinded placebo controlled study.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with erythropoietic protoporphyria
* At least 18 years of age
* Obtainment of written informed consent

Exclusion Criteria:

* Pregnant or breastfeeding
* Use of dihydroxyacetone at the treatment or placebo fields within the last two week
* Sun exposure of the treatment or placebo fields within the last two week
* Use of suncreen or other local treatment on the treatment or placebo fields during the study period (two days)
* Allergy to adhesive bandages, dihydroxyacetone or lotion

Primary outcomes:
measure: Visible light exposure dose to onset of first skin symptom
timeFrame: Meassurement one day after dihydroxyacetone application
Secondary outcomes:
measure: Change in skin color from before treatment to one day after treatment
timeFrame: Meassurement of skin color just before dihydroxyacetone application and one day after application.
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Ida Marie Heerfordt
Study officials:
References:
Clinical trial NCT01223040: An Open-Label, Single-Center Study Evaluating the Effect of Systane Balance on Video Ocular Protection Index (OPI) and Blink Patterns in Patients Diagnosed With Dry Eye
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye Syndrome
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2010-10-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effect of acute and repeat dosing of Systane Balance on Video Ocular Protection Index (OPI) and Blink Patterns in a population of dry eye patients.


Eligibility criteria: Inclusion Criteria:

* Patients must have history of mild-moderate dry eye with use of (or desire to use) eye drops in past 6 months

Exclusion Criteria:

* Patients cannot wear contact lenses within 1 week prior nor during the study, and cannot have a history of hypersensitivity to any component of Systane Balance.

Primary outcomes:
measure: Changes in video Ocular Protection Index 10 and 55 minutes following Systane Balance instillation at Days 1 and 7.
timeFrame: 8 days
Secondary outcomes:
measure: Changes in blink pattern in subjects with mean Interblink Interval (IBI) < 3 seconds at Days 2 and 8
timeFrame: 9 days
measure: Fluorescein staining at Visits 1 & 3 on the Ora staining scale
timeFrame: 9 days
measure: Ocular Symptomology at each visit
timeFrame: 9 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05316740: Vaginal Microbiome and the Development of Vulvovaginal Graft Versus Host Disease
Official title: Vaginal Microbiome and the Risk of Vulvovaginal Graft Versus Host Disease Following Hematopoietic Stem Cell Transplantation
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Bone Marrow Transplant Complications
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
Collaborators: name: Rambam Health Care Campus
name: Tel-Aviv Sourasky Medical Center
First posted: 2022-04-07
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Female patients planned for HSCT

Brief summary: Allogeneic stem cell transplantation (also termed "bone marrow transplantation") involves transferring stem cells from a healthy person (the donor) to the patient, after high-intensity chemotherapy or radiation, given to destroy any remaining cancer cells in the body. When a transplant is successful, the donor stem cells replace the original cells in the bone marrow. It may provide the only long-term cure of the patient's disease. Of transplant-related complications, graft-versus-host disease (GVHD) is one of the most important complications. GVHD arises from donor immune cells, that identify the recipient's (the patien's) cells as foreign and attack them. Approximately half of women undergoing transplantation will experience GVHD involving the genitalia (i.e., the vulva and vagina), termed vulvovaginal GVHD (VV-GVHD). VV-GVHD may cause irreversible anatomical changes, including complete vaginal obliteration, and not surprisingly, it has a severe impact on patients' quality of life and sexual function. This complication is unpredictable and non-preventable by the usual immunosuppressive treatment given to patients. Frequent gynecological examinations and prolonged follow-up of transplanted women are needed, to allow early diagnosis and prevention of harmful results of VV-GVHD. This follow-up adds inconvenience and anxiety to the patients.

The suggested study aims to evaluate a possible association between vaginal microorganisms (the "microbiome") to the progress of VV-GVHD. Finding such association may allow prediction of VV-GVHD progress, a better understanding of the development of VV-GVHD and a potential to develop interventions for the treatment and prevention of VV-GVHD.


Eligibility criteria: Inclusion Criteria:

* Age≥18
* Candidate for allogeneic stem cell transplantation
* Ability to sign an informed consent

Exclusion Criteria:

- Patient does not approve sample collection

Primary outcomes:
measure: Microbiome composition
timeFrame: 2 years
measure: CMV presence
timeFrame: 2 years
measure: Vulvovaginal graft vs host disease presence
timeFrame: 2 years
Secondary outcomes:
measure: HPV presence
timeFrame: 2 years
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
Study officials:
affiliation: Hadassah Medical Organization
name: Ahinoam Lev Sagie, MD
role: PRINCIPAL_INVESTIGATOR
References: