louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06786156: Pregnant Women with Placenta Previa
Official title: The Effect of Fetal Movement Counting Given with Pecha Kucha Education on Prenatal Bonding and Pregnancy Distress in Pregnant Women with Placenta Previa
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Placental Previa
Keywords: Fetal Movement
Pecha Kucha
Pregnancy Distress
Placental Previa
Lead sponsor: Burdur Mehmet Akif Ersoy University
Sponsor class: OTHER
First posted: 2025-01-22
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Placenta previa is the extension of placental tissue over the endocervical os or covering the cervical os. Placenta previa is a common complication in the third trimester of pregnancy and is a major cause of postpartum hemorrhage and perinatal death.There are many studies in the literature on attachment. However, no studies have been found on fetal movement in placenta previa pregnant women. Counting fetal movements is an easy and inexpensive assessment that pregnant women can do on their own, without the need for any specialist or equipment, and for which they take responsibility. It is assumed that the effective time spent during fetal movement counting will positively affect the attachment between the pregnant woman and the fetus, and that the stress of the pregnant woman, who is sure that her baby is well, will decrease.


Eligibility criteria: Inclusion Criteria:

* Between the ages of 18-45

  * In the second trimester,
  * Primiparous,
  * With adequate communication skills
  * Literate,
  * Able to read and understand Turkish,

Exclusion Criteria:

Having any mental illness

* Having communication, hearing or vision problems that prevent you from answering the data collection tools

Primary outcomes:
measure: Prenatal attachment scale
timeFrame: aseline and 3 months.
measure: Tilburg pregnancy distress scale
timeFrame: aseline and 3 months.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01468285: The CBF Study Evaluating the Effect of Betahistine on the Cerebral Blood Flow
Official title: A Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Pilot Study to Evaluate the Effect of Betahistine on Cerebral Blood Flow and Gait in Subjects at Risk of Falling
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gait or Balance Disorder Problems
Keywords: interventional,placebo controlled
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2011-11-09
Enrollment: 27
Sex: ALL
Minimum age (years): 40
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Betahistine may provide benefit by enhancement of Cerebral Blood Flow (CBF). This placebo-controlled pharmacodynamic treatment study will primarily explore the effect of betahistine on cerebral blood flow measured by dynamic contrast-enhanced MRI imaging, in a patient population with MRI evidence of cerebrovascular compromise. Also it will be measured if CBF changes correlate with gait and cognitive changes.


Eligibility criteria: Inclusion Criteria:

1. Subjects with gait or balance disorder problems
2. Male and female subjects aged on 40 years and above.
3. Absence of known contraindications for betahistine treatment.
4. Currently not on betahistine (of any formulation) treatment for at least 45 days prior to inclusion in the study.
5. Subject consuming caffeinated or alcoholic beverages should have stable consumption throughout the study period.

Exclusion Criteria:

1. History of discontinuation of betahistine treatment (of any formulation) in the past due to lack of efficacy or side effects.
2. Subjects treated with antihistamines and monoamine oxidase (MAO) inhibitors 30 days prior to inclusion in the study.
3. Subjects with hypersensitivity to the active substance or to any of the excipients of the drug.
4. Phaeochromocytoma
5. Porphyria

Primary outcomes:
measure: Cerebral Blood Flow (CBF)
timeFrame: 6 weeks
Secondary outcomes:
measure: Regional Cerebral Blood Flow (rCBF)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Site Reference ID/Investigator# 63545
city: Singapore
country: Singapore
facility: Site Reference ID/Investigator# 63544
Study officials:
affiliation: Abbott
name: Dmitri Kazei, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00823056: The Effect of Probiotics on Infections in Toddlers
Official title: The Effect of Probiotics on Infections in Toddlers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diarrhoea
Respiratory Diseases
Keywords: Probiotics
Infections
Children
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
Collaborators: name: Holbaek Sygehus
name: Dept. of Microbiology, Slagelse University Hospital, Region Zealand,DK
name: Chr Hansen
name: Ferrosan A/S
First posted: 2009-01-15
Enrollment: 454
Sex: ALL
Minimum age (years): 6
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Probiotics has been known as a dietary supplement for a long period. Recent clinical trials indicate that probiotics might have an effect in preventing common infection diseases in children.

The investigators hypothesis is: if young children in the age of 6 month to 15 mdr. has a daily intake of a suspension containing probiotics in a period of 9 months, the incidence of diarrhoea and respiratory diseases can be reduced.

Detailed description: Probiotics has been known as a dietary supplement for a long period. Recent clinical trials indicate that probiotics might have an effect in preventing common infection diseases in children.

Our hypothesis is: if young healthy children in the age of 6 month to 15 mdr. has a daily intake of a suspension containing probiotics( BB12 and TH4) in a period of 9 months, the incidence of diarrhoea and respiratory diseases can be reduced.

Eligibility criteria: Inclusion Criteria:

* Healthy Children born in University Hospital Holbaek,Hospital North,Region Zealand, Denmark in the period of Jan. 2009 to Oct. 2010
* Gestational age \> 36. weeks

Exclusion Criteria:

* Chronical heart or lung conditions
* Short Bowel Syndrome
* CVC (Central Venous Catheter)

Primary outcomes:
measure: fewer infections
timeFrame: 9 months
Secondary outcomes:
measure: growth
timeFrame: 9 months
Other outcomes:
Locations:
city: Holbaek
country: Denmark
facility: Paediatr. Depart., University Hospital Holbaek, University of Copenhagen
state: Region Zealand
Study officials:
affiliation: ph.d student
name: Mette L. Gyhrs, MD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nielsen AC, Gyhrs ML, Nielsen LP, Pedersen C, Bottiger B. Gastroenteritis and the novel picornaviruses aichi virus, cosavirus, saffold virus, and salivirus in young children. J Clin Virol. 2013 Jul;57(3):239-42. doi: 10.1016/j.jcv.2013.03.015. Epub 2013 Apr 19.
Clinical trial NCT02645656: Topical Application of Curcumin Orabase in Oral Submucous Fibrosis (OSMF)
Official title: Topical Application of Curcumin Incorporated in Orabase in OSMF Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Oral Submucous Fibrosis
Keywords: Oral Submucous Fibrosis
Curcumin
Lead sponsor: SVS Institute of Dental Sciences
Sponsor class: OTHER
First posted: 2016-01-05
Enrollment: 30
Sex: ALL
Minimum age (years): 22
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Curcumin (diferuloylmethane) is the chief component of the spice turmeric and is derived from the rhizome of the East Indian plant Curcuma longa. Curcuma longais a member of the Zingiberacae (ginger) family of botanicals and is a perennial plant that is native to Southeast Asia. Turmeric contains a class of compounds known as the curcuminoids, comprised of curcumin, demethoxy curcumin and bisdemethoxycurcumin.

Detailed description: Anti-inflammatory mechanisms implicated in the anticarcinogenic potential of curcumin include: (1) inhibition of NF-κB and COX-2 (increased levels of COX-2 are associated with many cancer types); (2)inhibition of arachidonic acid metabolism via lipoxygenase and scavenging of free radicals generated in this pathway; (3) decreased expression of inflammatory cytokines IL-1b, IL-6, and TNF-a, resulting in growth inhibition of cancer cell lines; and (4) down-regulation of enzymes, such as protein kinase C, that mediate inflammation and tumor-cell proliferation.

Curcumin's potent anti-oxidant and free-radical quenching properties play an important role in the inhibitory effects of the compound on the initial stages of carcinogenesis. Antioxidants are implicated in the pathogenesis of OSMF and hence this preparation may be helpful in resolution of this lesion.

Eligibility criteria: Inclusion Criteria:

* Subjects showing classic clinical signs of OSMF and not under any intervention for the same will be included.

Exclusion Criteria:

* Subjects who are receiving or have received any form of therapy in the six month period leading to the study will be excluded.

Primary outcomes:
measure: Reduction in OSMF lesion
timeFrame: up to 6 months
Secondary outcomes:
measure: Jaw Opening
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: SVS Institute of Dental Sciences, Mahabubnagar
state: Andhra Pradesh
Study officials:
affiliation: Academic Commitee
name: Ramaraju Devaraju, MDS
role: STUDY_DIRECTOR
References:
Clinical trial NCT04641156: Effect of Physical Therapy Exercise Program and Low-Level Laser Therapy on the Treatment of Cervicogenic Somatosensory Tinnitus
Official title: Effect of Adding Supervised Physical Therapy Exercise Program to Photobiomodulation Therapy in the Treatment of Cervicogenic Somatosensory Tinnitus: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tinnitus, Subjective
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-11-23
Enrollment: 40
Minimum age (years): 45
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine the effectiveness of adding a physical therapy exercise program to low-level laser therapy on the treatment of chronic tinnitus treatment


Eligibility criteria: Inclusion Criteria:

* Age ranged from 45 to 55 years old both sex
* Unilateral tinnitus
* Stable tinnitus for at least 3 months
* suffering from severe chronic non-fluctuating subjective cervicogenic somatic tinnitus (CST)

Exclusion Criteria:

* tinnitus with clear ontological etiologies as perforation of the tympanic membrane
* external otitis media
* conductive hearing loss
* patients with a traumatic cervical spine injury, tumors
* Any history of exposure to ototoxic drugs/substances
* psychotic disorders with auditory hallucination

Primary outcomes:
measure: VAS
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Marwa Eid
Study officials:
References:
Clinical trial NCT02718456: Overcoming Barriers to HIV/AIDS Care and ART Initiation
Official title: Overcoming Barriers to HIV/AIDS Care and ART Initiation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Engagement in HIV Care
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2016-03-24
Enrollment: 315
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The study will evaluate interventions to improve engagement in HIV care following HIV diagnosis through a voluntary counseling and testing program. The specific aims are to (1) determine if a VCT-based intervention of CD4 count testing, alone or in combination with peer counseling, improves linkage to HIV/AIDS care; (2) assess the impact of the intervention on ART initiation. The study will recruit 450 HIV-positive individuals from VCTs and randomize a third to standard counseling and referral, a third to receive CD4 testing at the VCT with results return by phone after 1 weeks, and a third to receive the same CD4 testing combined with peer counseling. These combined investigations will create a comprehensive understanding of obstacles to appropriate HIV/AIDS care and result in new interventions to achieve measurable outcomes in applied settings.


Eligibility criteria: Inclusion Criteria:

* At least 18 years or older and
* Testing HIV-positive for the first time at a voluntary counseling and testing (VCT) center.
* Willing to receive counseling to encourage linkage to care at a comprehensive care center (CCC).
* Willing to have a CD4 count test conducted at the enrollment visit.
* Willing to have a telephone follow-up where they may receive additional counseling and/or have their CD4 count results returned to them.
* Willing to be contacted over 1 year to determine if they linked to care.

Exclusion Criteria:

* Previous positive HIV test.
* Currently taking antiretroviral medications.
* Currently pregnant (females only).
* Currently participating in another research study or trial.
* Not planning to remain in Nairobi for the next 12 months (not including short trips out of Nairobi).

Primary outcomes:
measure: Number of days from study enrollment until first visit to a comprehensive care center for HIV care.
timeFrame: 1 year
measure: Number of days from study enrollment until initiation of antiretroviral therapy.
timeFrame: 1 year
Secondary outcomes:
measure: Interviewer-administered questionnaire to determine the number of visits made to a comprehensive care center for HIV care.
timeFrame: 1 year
measure: Measurement of CD4+ T-cell count.
timeFrame: 1 year
Other outcomes:
Locations:
city: Nairobi
country: Kenya
facility: Karen Health Center
Study officials:
affiliation: University of Washington
name: Brandon L Guthrie, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04378556: Improving Dietary Protein Intake in Adults
Official title: Improving Dietary Protein Intake in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Protein intake
Coaching
Strength
Lead sponsor: Florida Atlantic University
Sponsor class: OTHER
First posted: 2020-05-07
Enrollment: 29
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Repeated measures design
Primary purpose: SUPPORTIVE_CARE

Brief summary: A pilot, single-arm investigation used coaching, nutrition education, and a per-meal protein prescription to assess impact on protein intake, muscle strength and function in older adults.

Detailed description: Objective: To evaluate the effects of nutrition education, diet coaching, and a protein prescription (PP) on protein intake, and associations with muscle strength and function. Design: Prospective pretest posttest single-arm study. Setting: Urban area, East coast of South Florida. Participants: Older adults. Intervention: 10-week telephone-based diet coaching, nutrition education and a per-meal PP. Measurements: Protein and energy intakes, weight, grip strength (GS), and 5-chair-rise (5CR), timed up and go (TUG), 3-meter walk (3mW) tests at baseline and 10 weeks.

Eligibility criteria: Inclusion Criteria:

* Adults aged 55 years or older,
* Community-dwelling (living independently),
* Able to provide consent,
* Able to understand and respond to questions or instructions in English,
* Have a working telephone (for coaching sessions),
* Willingness to consume protein-containing animal products
* Willingness to make changes to the diet

Exclusion Criteria:

* Self-reported information that they have been told by a medical doctor that they have kidney (renal) disease.
* Vegan dietary practices,
* Refusal to make changes to usual dietary protein intake, or a usual dietary protein intake that meets recommendations.

Primary outcomes:
measure: Change in Protein intake
timeFrame: Change from baseline to 10 weeks
Secondary outcomes:
measure: Change in Grip strength
timeFrame: Change from baseline to 10 weeks
measure: Change in Timed Up and Go Test
timeFrame: Change from baseline to 10 weeks
measure: Change in 3 meter walk
timeFrame: Change from baseline to 10 weeks
measure: Change in 5-Chair Rise Stand Test
timeFrame: Change from baseline to 10 weeks
measure: Change in Short Performance Physical Battery Score
timeFrame: Change from baseline to 10 weeks
Other outcomes:
Locations:
city: Boca Raton
country: United States
facility: Florida Atlantic University
state: Florida
Study officials:
References:
Clinical trial NCT03667456: Evaluation of the Uses of a Digital-assisted Self-rehabilitation Device (TELE-PARK)
Official title: Evaluation of the Uses of a Digital-assisted Self-rehabilitation Device Coupled With a Tele-reeducative Follow-up in Patients With Parkinson's Disease on a Defined Health Area (TELE-PARK)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Parkinson's Syndrome
Keywords: Parkinson
Serious Game
Self management
Rehabilitation
Telemedicine
Lead sponsor: Pôle Saint Hélier
Sponsor class: OTHER
Collaborators: name: Réseau Parkinson Bretagne
name: Rennes University Hospital
First posted: 2018-09-12
Enrollment: 31
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: Evaluate the use by the patient and his family and professional environment of a self-rehabilitation device with follow-up in tele-rehabilitation in people with Parkinson's disease taking into account the different actors within a health area (health professionals and paramedics in structure and in liberal).


Eligibility criteria: Inclusion Criteria:

Patients:

* Men and women over the age of 18
* With Parkinson's syndrome due to idiopathic Parkinson's disease or related syndromes
* Presenting a complaint about balance and/or walking
* With possible walking over a perimeter of at least 100 meters with or without technical aid
* Hoehn and Yahr scale \< or = to 4
* Formulating their free and informed consent in writing.

Health professionals:

- physiotherapists and physiatrists hospital or voluntary volunteers practicing in the territory of health 5 in Brittany agreeing to participate in the study

Exclusion Criteria:

* Orthopedic and rheumatologic pathologies that may prevent the achievement of measures
* Comprehension disorders preventing the implementation of the protocol

Primary outcomes:
measure: UTAUT Questionnaire
timeFrame: 12 months
Secondary outcomes:
measure: UTAUT Questionnaire
timeFrame: 12 months
measure: Observance
timeFrame: 12 months
measure: SF36
timeFrame: 12 months
measure: Rosenberg SES
timeFrame: 12 months
measure: Zarit's Score
timeFrame: 12 months
measure: Performance indicators
timeFrame: 12 months
measure: VAS Satisfaction
timeFrame: 12 months
Other outcomes:
Locations:
city: Rennes
country: France
facility: Pôle Saint Hélier
state: Bretagne
Study officials:
affiliation: Pole Saint Hélier
name: Philippe Gallien, Doctor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01348256: Study With Dendritic Cell Immunotherapy in Resected Hepatic Metastasis of Colorectal Carcinoma
Official title: Randomized Phase II Study With Dendritic Cell Immunotherapy in Patients With Resected Hepatic Metastasis of Colorectal Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Colorectal Carcinoma
Hepatic Metastasis
Keywords: colorectal carcinoma
resectable hepatic metastasis
adjuvant treatment
dendritic cells
Lead sponsor: Clinica Universidad de Navarra, Universidad de Navarra
Sponsor class: OTHER
First posted: 2011-05-05
Enrollment: 58
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: In this randomized multicentric phase II study, patients with colorectal carcinoma with resectable hepatic metastasis will be randomized to treatment with dendritic cells or to observation, following conventional treatment with surgery and chemotherapy.


Eligibility criteria: Inclusion Criteria:

1. Age over 18 years.
2. Confirmed diagnosis of colorectal cancer with hepatic metastasis, amenable for surgical treatment.
3. Capacity of understanding and signing the informed consent and to undergo the study procedures
4. Availability of tumor tissue, for maturing dendritic cells
5. Adequate renal, hepatic and bone marrow function

Exclusion Criteria:

1. Clinically relevant diseases or infections.
2. Concurrent participation in other clinical trial or administration or other antitumoral treatment
3. Concurrent cancer, with the exceptions allowed by the principal investigator (PI).
4. Pregnant or breast feeding women
5. Immunosuppressant treatment

Primary outcomes:
measure: Progression Free survival
timeFrame: Progression free survival at 2 years
Secondary outcomes:
measure: Overall survival
timeFrame: 2 years
Other outcomes:
Locations:
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra
state: Navarra
city: Pamplona
country: Spain
facility: Hospital de Navarra
state: Navarra
Study officials:
affiliation: University of Navarra
name: Ignacio Melero, MDPhD
role: STUDY_CHAIR
References:
citation: Rodriguez J, Castanon E, Perez-Gracia JL, Rodriguez I, Viudez A, Alfaro C, Onate C, Perez G, Rotellar F, Inoges S, Lopez-Diaz de Cerio A, Resano L, Ponz-Sarvise M, Rodriguez-Ruiz ME, Chopitea A, Vera R, Melero I. A randomized phase II clinical trial of dendritic cell vaccination following complete resection of colon cancer liver metastasis. J Immunother Cancer. 2018 Sep 29;6(1):96. doi: 10.1186/s40425-018-0405-z.