louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00612248: Functional Splint for Osteoarthritis of the Trapeziometacarpal Joint
Official title: Assessment of the Effectiveness of a Functional Splint for Osteoarthritis of the Trapeziometacarpal Joint on the Dominant Hand: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoarthritis
Keywords: Osteoarthritis
Thumb
Splint
Pain
Function
Osteoarthritis of the trapeziometacarpal (TMC) joint
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2008-02-11
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Forty participants were enrolled in a randomized, controlled clinical trial to evaluate the effectiveness of a functional thumb splint for trapeziometacarpal OA in the dominant hand.

Detailed description: Treatment, Randomized, Single Blind, Placebo Control, Parallel Assignment, Efficacy Study

Eligibility criteria: Inclusion Criteria:

* clinical and radiological diagnosis of idiopathic Grade II and III OA of the TMC joint on the dominant hand;
* either gender;
* over 40 years of age;
* pain in the base of the thumb of the dominant hand greater than three and less than or equal to seven on the 0 to 10-cm visual analogue scale (VAS) for pain.

Exclusion Criteria:

* severe deformities of the dominant hand that did not allow gripping between the first, second and third fingers;
* deformities of distal interphalangeal joint;
* use of a splint on the thumb in the previous six months;
* surgery on the hand under study in the previous six months or scheduled in the upcoming six months;
* allergy to the splint material;
* incapacity to respond to the questionnaire and perform the tests;
* geographic inaccessibility;
* injections in the hand under study in the previous six months;
* other associated diseases such as carpal tunnel syndrome, fractures in the carpus, tendonitis, chronic inflammatory arthropathy;
* alterations in the use of anti-inflammatory medication and analgesics in the previous three months.

Primary outcomes:
measure: Pain (VAS)
timeFrame: baseline (T0), after 45 days (T45), after 90 dias (T90) and after 180 dias (T180)
Secondary outcomes:
measure: Function (DASH)
timeFrame: baseline (T0), after 45 days (T45), after 90 dias (T90) and after 180 dias (T180)
measure: Grip and pinch strength (dynamometer)
timeFrame: baseline (T0), after 45 days (T45), after 90 dias (T90) and after 180 dias (T180)
measure: Dexterity (O'Connor test)
timeFrame: baseline (T0), after 45 days (T45), after 90 dias (T90) and after 180 dias (T180)
Other outcomes:
Locations:
Study officials:
affiliation: Federal University of São Paulo
name: Jamil Natour, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03845348: To Evaluate the Efficacy and Safety of Shampoo TD03 and TD07 in Scalp Diseases
Official title: Đánh giá hiệu quả điều trị viêm da dầu ở đầu của dầu gội Thái Dương 3 và Thái Dương 7 (A Randomized, Double Blind, Placebo Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy Shampoos TD03 and TD07 in Scalp Diseases)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Scalp Dermatitis
Lead sponsor: Sao Thai Duong Joint Stock Company
Sponsor class: INDUSTRY
Collaborators: name: Big Leap Research
First posted: 2019-02-19
Enrollment: 366
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: Scalp Conditions are common chronic skin inflamations with the occurence rate of 1 - 5 % among the population. TD03 shampoo and TD07 shampoo are widely used to avoid hair loss with successful rate reaching nearly 95%. This trial is going to evaluate the efficacy of getting rid of dandruff as well as the safety of the investigational products in comparison to a reference (ketoconazole 2%) during a 4-week treatment period.

Detailed description: Scalp Conditions are common chronic skin inflamations with the occurence rate of 1 - 5 % among the population. TD03 shampoo and TD07 shampoo are widely used to avoid hair loss with successful rate reaching nearly 95%. With herbal ingredients including Gleditsia, Morus alba, Ocimum tenuiflorum, Oroxylum indicum, Ageratum conyzoides, the investigational products could reduce the severity of inflamation, infection and help to prevent hair loss. This trial is planning to evaluate the efficacy of the IPs in terms of inflamation reduction, dandruff reduction on subjects using the IPs compared to a reference (ketoconazole 2%).

The trial is intended to last for 18 months with subject visits and 3 arms (122 subjects per arm). The first arm receive TD3 while TD7 is provided to the second arm in comparison to the placebo of the last arm. It will be conducted at National Hospital of Dermato - Venerology, Vietnam.

Eligibility criteria: Inclusion Criteria:

* \> 18 years old and signed the ICF.
* Diagnosed with head skin inflamtion with IGA \<= 3.
* Voluntary sign the ICF before any procedures.
* No hypersentivity to the IP.

Exclusion Criteria:

* Use oral antifungal 1 month prior to the trial participation or topical antifungal 2 weeks prior to the trial participation.
* Suffering chronic or acute diseases that may affect the trial.

Primary outcomes:
measure: Change from baseline in IGA scale at 4 week-treatment
timeFrame: 4 weeks
measure: The numbers of subjects with AE/SAE
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: Nationa Hospital of Dermatology
Study officials:
affiliation: National Hospital of Dermatology
name: Phuong TM Pham
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02767648: Inter-regional Cohort of Neonatal and Infant Cholestasis in the Greater Southwest Region
Official title: Inter-regional Cohort of Neonatal and Infant Cholestasis in the Greater Southwest Region
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cholestasis
Keywords: cholestasis
neonatal
infant
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2016-05-10
Enrollment: 57
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: infant suffering from cholestasis

Brief summary: The goal of the study is to characterize the epidemiologic data of the neonatal and infant cholestasis.


Eligibility criteria: Inclusion Criteria:

* Infant \<1 year suffering from cholestasis

Exclusion Criteria:

* Rejection or inability for parent to give their informed consent

Primary outcomes:
measure: Gathering mother epidemiologic characteristics as assessed by pregancy informations collection
timeFrame: Day 1 (inclusion)
measure: Gathering new born epidemiologic characteristics as assessed by birth informations collection
timeFrame: Day 1 (inclusion)
measure: Epidemiologic characteristics follow up as assessed by medical monitoring
timeFrame: When children are between 12 and 18 months old
Secondary outcomes:
measure: Homogenization of diagnosis and treatment of new born with the constitution and follow up of a prospective cohorte
timeFrame: Up to 3 years
measure: Extend the study to the national french territory using the hepatology association network
timeFrame: Up to 3 years
measure: Identification of proteomic profiles using the biologic collection gathered in the cohorte population
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: UH Bordeaux
city: Limoges
country: France
facility: UH Limoges
city: Montpellier
country: France
facility: UH Montpellier
city: Toulouse
country: France
facility: UH Toulouse
Study officials:
affiliation: UH Toulouse
name: Pierre Broue, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Bordeaux
name: Thierry Lamireau, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UH Limoges
name: Jane Languepin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UH Monptellier
name: Sebastien Fournier-Favre, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02026648: Outcome of Women With Cervical Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Cancer
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2014-01-03
Enrollment: 81
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: the cases with cervical cancer

Brief summary: Squamous cell carcinoma (SCC) of the cervix has showed a marked decline in developed countries over the past 40 years, however, there has also been an increase in relative and absolute incidence of adenocarcinoma and adenosquamous carcinoma (AC) of the uterine cervix over the same period.

Our understanding of the natural history and optimal management of AC is limited. It appears that AC and SCC of the cervix behave differently. They are different in epidemiology, prognostic factors, and patterns of failure after similar treatments. Available data suggest that they may also differ in their response to treatment. We postulate that new treatment strategies specifically tailored to AC should be explored.

However, there is few data about outcome of cervical cancer in Taiwan. So we propose this proposal for retrospective analysis of clinicopathological parameters and outcomes in patients of cervical cancer, especially for cervical adenocarcinoma and adenosquamous carcinoma.


Eligibility criteria: Inclusion Criteria:

* Time interval: from 1991 to date.
* Comprehensive surgical staging, debulking procedure, radiotherapy or chemotherapy.
* All female patients with cervical cancer who underwent treatment for cervical cancer at Far Eastern Memorial Hospital.
* All the patients diagnosed as cervical cancer, especially for women with adeno- and adenosquamous carcinoma.
* To review:

  1. Clinical data: including age at diagnosis, presenting symptoms, gravidity, parity, menstrual history, body mass index, history of diabetes, hypertension, personal history of cancer and staging.
  2. Pathologic information: deep stromal invasion, lymph-vascular space invasion, lymph node involvement, parametrium invasion, vaginal cut end and tumor size.
  3. Survival data: disease-free and overall survival.
  4. Radiation report, Chemotherapy treatment, operation, discharge and admission note.

Exclusion Criteria:

* Not comprehensive staging/debulking procedure.
* Patients who died of postoperative complications within 30 days after surgery were excluded from the survival analysis.
* Female minors or disabled persons.

Primary outcomes:
measure: Outcome of women with cervical cancer
timeFrame: 20 years
Secondary outcomes:
Other outcomes:
Locations:
city: Banqiao
country: Taiwan
facility: Far Eastern Memorial Hospital
state: Taipei
Study officials:
References:
Clinical trial NCT06490848: Comparing the Safety and Efficacy of Cerebral TFA and TRA Methods
Official title: Comparing the Safety and Efficacy of Cerebral Angiography Using Trans-femoral Approach Versus Trans-radial Approach
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cerebral Angiography
Lead sponsor: Mashhad University of Medical Sciences
Sponsor class: OTHER
First posted: 2024-07-08
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In this study, all consecutive patients referred for diagnostic cerebral angiography at a large academic tertiary care medical center were randomly assigned to two groups: right radial access versus femoral access for diagnostic cerebral angiography.
Primary purpose: DIAGNOSTIC

Brief summary: Transradial diagnostic angiography in cardiovascular disease given lower vascular complications. However, neuroendovascular surgeons have not widely adopted the transradial approach for diagnostic approach and interventional procedures. This study aims to compare the efficacy, safety, and patient satisfaction with the transradial approach versus the transfemoral approach in diagnostic cerebral angiography.

Detailed description: Transradial diagnostic angiography in cardiovascular disease given lower vascular complications. However, neuroendovascular surgeons have not widely adopted the transradial approach for diagnostic approach and interventional procedures. This study aims to compare the efficacy, safety, and patient satisfaction with the transradial approach versus the transfemoral approach in diagnostic cerebral angiography.

Eligibility criteria: Inclusion Criteria:

* All consecutive adult inpatients and outpatients referred for diagnostic cerebral angiography
* the presence of the right radial pulse and at least one femoral pulse

Exclusion Criteria:

* age\<18
* pregnant patients
* occlusion of aorta or proximal both iliac/ femoral artery

Primary outcomes:
measure: technical success
timeFrame: during procedure
measure: access success
timeFrame: during procedure
Secondary outcomes:
measure: total procedure time
timeFrame: during procedure
measure: total fluoroscopy time
timeFrame: during procedure
measure: complication
timeFrame: during procedure or one week after procedure
Other outcomes:
measure: Patient Satisfaction
timeFrame: immediately after procedure, one hour after the procedure
Locations:
city: Mashhad
country: Iran, Islamic Republic of
facility: Mashhad university of medical sciences
state: Razavi Khorasan
Study officials:
References:
Clinical trial NCT01012648: Early Fluid Resuscitation With Balanced HES 130/0.4 [6%] in Severe Burn Injury
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Burns
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2009-11-13
Enrollment: 48
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: RCT colloids versus cristalloids only in severe burn victims.

* Trial with medicinal product


Eligibility criteria: Inclusion criteria:

* Deep burn injury more than 15% of total body surface area (2nd and 3rd degree burns)
* Informed consent (via deferred consent, if necessary, according to Swiss HMG § 55 and 56).
* Patients or relatives can understand the study information and the provided information in German language

Exclusion criteria:

* Patients expected to succumb within the next 24 to 36 hours, i.e. whole body burn trauma, palliative care situation
* Pregnancy
* No informed consent
* Known allergic reaction to HES
* Patients or patient's relatives, who do not understand the German language and therefore the study information, can not be provided in a legally correct manner.
* Patients with contraindications for balanced 6% HES 130/0.4, i.e. heart failure, pulmonary edema, intracerebral bleeding, acute renal failure, severe hypernatraemia and other severe electrolyte imbalances, severe von-Willebrand Syndrome and acute liver failure (see "Arzneimittelkompendium der Schweiz® - Documed")

Primary outcomes:
measure: Reduced amount of fluids given
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Surgical ICU
Study officials:
affiliation: UniversitaetsSpital Zuerich
name: Markus Béchir, M.D:
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bechir M, Puhan MA, Fasshauer M, Schuepbach RA, Stocker R, Neff TA. Early fluid resuscitation with hydroxyethyl starch 130/0.4 (6%) in severe burn injury: a randomized, controlled, double-blind clinical trial. Crit Care. 2013 Dec 23;17(6):R299. doi: 10.1186/cc13168.
Clinical trial NCT01201148: Open Pilot Trial of TES for Depression
Official title: A Study of Transcranial Electrical Stimulation (TES) for the Treatment of Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Major Depression
Keywords: depression
transcranial direct current stimulation (tDCS)
random noise stimulation
oscillatory tDCS
intermittent tDCS
Lead sponsor: The University of New South Wales
Sponsor class: OTHER
First posted: 2010-09-14
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will investigate whether using oscillating TES (random noise stimulation) or intermittent tDCS will have greater antidepressant effects in depressed subjects, compared to standard tDCS.


Eligibility criteria: Inclusion Criteria:

* Subject meets criteria for a DSM-IV Major Depressive episode.

Exclusion Criteria:

* Diagnosis (as defined by DSM-IV) of: any psychotic disorder (lifetime); bipolar disorder; eating disorder (current or within the past year); obsessive compulsive disorder (lifetime); post-traumatic stress disorder (current or within the past year); mental retardation.
* Subject has not responded adequately to standard tDCS or is not appropriate for trial of standard tDCS (eg depression too chronic in duration)
* Total MADRS depression score of 20 or more
* History of drug or alcohol abuse or dependence (as per DSM-IV criteria) within the last 3 months (except nicotine and caffeine).
* Inadequate response to ECT in the current episode of depression.
* Subject is on regular benzodiazepine medication which it is not clinically appropriate to discontinue.
* Subject requires a rapid clinical response due to inanition, psychosis or high suicide risk.
* Neurological disorder or insult, e.g., recent stroke (CVA), which places subject at risk of seizure or neuronal damage with TES.
* Subject has metal in the cranium, skull defects, or skin lesions on scalp (cuts, abrasions, rash) at proposed electrode sites.
* Female subject who is pregnant. However, women of child bearing age are eligible if they have the pregnancy test but will be excluded if they are sexually active and not using reliable contraception (urine test for pregnancy will be used if appropriate).

Primary outcomes:
measure: Montgomery Asberg Depression Rating Scale for Depression (MADRS)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Black Dog Institute
state: New South Wales
Study officials:
affiliation: School of Psychiatry, University of New South Wales
name: Colleen Loo, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04126226: Quality of Life in Patients Treated for Tongue and/or Jaw Neoplasia Before and After Speech Therapy
Official title: Quality of Life in Patients Treated for Tongue and/or Jaw Neoplasia Before and After Speech Therapy: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tongue Cancer
Jaw Cancer
Oral Cancer
Intelligibility, Speech
Keywords: Speech therapy
Dysphagia
Speech Intelligibility
Quality of Life
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2019-10-15
Enrollment: 30
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 study aims to verify the impact of four speech therapy sessions on the Quality of Life of patients treated for malignant tongue and/or jaw cancer, using as measure specific questionnaires of speech and swallowing.

The hypothesis is that after treatment with exercises and speech therapy guidance, patients will present better indicators on Quality of Life related to speech and swallowing.


Eligibility criteria: Inclusion Criteria:

* Over 18 Years
* Tongue and/or Jaw Neoplasm
* Submitted to surgical treatment

Exclusion Criteria:

* Under 18 Years
* Cognitive impairment or deficits in language comprehension
* Previous speech therapy intervention
* Recurrence or active disease
* Death during the intervention

Primary outcomes:
measure: Changes in Quality of Life Scores related to swallowing
timeFrame: 1 month
measure: Changes in Quality of Life Scores related to speech
timeFrame: 1 month
Secondary outcomes:
measure: Changes in Dysphagia Classification
timeFrame: 1 month
measure: Changes in Speech Intelligibility Classification
timeFrame: 1 month
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: RS
Study officials:
affiliation: Hospital de Clínicas de Porto Alegre
name: Sady S da Costa, PHD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01680926: Metabolic Activation With Almased for Type 2 Diabetes Patients
Official title: Protein-rich Meal Replacement Significantly Reduces Weight, HbA1c and Daily Insulin Requirement Long-term in Patients With Type 2 Diabetes Mellitus and >100 U Insulin Per Day
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Type 2 Diabetes Mellitus
Keywords: type 2 diabetes mellitus
insulin
hbA1c
body weight
Lead sponsor: West German Center of Diabetes and Health
Sponsor class: OTHER
Collaborators: name: Almased Wellness GmbH
First posted: 2012-09-07
Enrollment: 22
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Overweight patients with type 2 diabetes are often being treated with an intensified insulin therapy. However, in many cases, even a high insulin dosage (\> 100 U per day) does not achieve satisfying metabolic control. A new therapy option is necessary that makes it possible to lower the daily insulin requirement and to improve metabolic control. The aim of this study was to investigate whether a protein-rich meal replacement is suitable to lower the daily insulin requirement and to reduce HbA1c and body weight.

Detailed description: The pilot study included patients with type 2 diabetes (n=22), that injected \>100 U insulin daily. During the first week, all three main meals were replaced with 50 g of a protein-rich meal replacement (Almased) (=1100 kcal per day). During weeks 2-4, only two meals were replaced and a protein-rich lunch was allowed. During weeks 5-12, only dinner was replaced. Clinical parameters were determined at the beginning of the study, after 4, 8 and 12 weeks as well as after 1.5 years of follow-up. Wilcoxon signed rank test was used for the intention-to-treat analysis and Mann-Whitney test for subgroup analyses.

Eligibility criteria: Inclusion Criteria:

* patients with type 2 diabetes
* BMI \> 27 kg/m2
* age 35-75 years
* insulin therapy \>100 U insulin per day

Exclusion Criteria:

* contraindication for a calorie reduced diet

Primary outcomes:
measure: insulin demand per day
timeFrame: 12 weeks
Secondary outcomes:
measure: HbA1c
timeFrame: 12 weeks
measure: body weight
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Düsseldorf
country: Germany
facility: West German Center of Diabetes and Health
Study officials:
affiliation: West German Center of Diabetes and Health
name: Stepahn Martin, MD
role: PRINCIPAL_INVESTIGATOR
References: