louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01666886: Efficacy of Additional Titration During Oral Appliance Treatment for Sleep-disordered Breathing.
Official title: Efficacy of Additional Titration During Oral Appliance Treatment for Sleep-disordered Breathing.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea Syndrome
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
First posted: 2012-08-16
Enrollment: 20
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: In the protocol "Predicting therapeutic outcome of mandibular advancement device treatment in obstructive sleep apnea (PROMAD)", 100 patients with obstructive sleep apnea are included and started MAD treatment at 75% of maximal protrusion. All patients underwent polysomnography with MAD in situ to evaluate the effect of the MAD on severity of sleep apnea. If the results of the polysomnography with MAD are unsuccessful (defined as a reduction in AHI with the MAD in situ of less than 50% compared to baseline), the therapy needs to be adjusted. Finding the most effective protrusion should be a weighted compromise between efficacy and side-effects of MAD therapy.

In patients with insufficient results on the polysomnography with the MAD at 75% of maximal protrusion, the MAD will be further adjusted until 90% of the maximal protrusion measured at the follow-up visit after the polysomnography with the MAD. After habituation and adaptation period but within 2 months after the first polysomnography with MAD, a new polysomnography will be performed to assess the effect of the 90% protruded position.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Body Mass Index (BMI) ≤ 35 kg/m²
* OSAS, as defined by the American Academy of Sleep Medicine Task Force
* apnea-hypopnea index (AHI) \< 50
* incomplete elimination of apneas and/or hypopnea during therapy with mandibular advancement device in 75% of maximal protrusion

Exclusion Criteria:

* Other sleep disorders (i.e. parasomnias)
* Invasive upper airway surgery for sleep-disordered breathing
* Known genetic disorders with craniofacial and/or upper airway malformations
* Use of benzodiazepine and/or antidepressants
* Known history of psychiatric disease
* Known history of fibromyalgia and/or chronic fatigue syndrome
* Dental contra-indications: functional restrictions of the temporomandibular joint, insufficient dentition with pathological changes, insufficient retention for MAD use

Primary outcomes:
measure: Polysomnographic efficacy
timeFrame: 3 to 6 months after start of therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Wilrijk
country: Belgium
facility: Antwerp University Hospital
state: Antwerp
Study officials:
References:
Clinical trial NCT05247086: Negative Pressure Therapy After Infected Mesh Removal.
Official title: Usefulness of Negative Pressure Therapy After Mesh Removal Due to Chronic Infection: a Multicentric, Prospective, Randomized Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infection, Surgical Site
Lead sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Sponsor class: OTHER
First posted: 2022-02-18
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Chronic mesh infection mesh is a complication with leads to a long hospital stays, reoperation and admissions through emergency department. Surgical site infection (SSI) after removal are 58-72.7% depending on the published series. New therapeutic lines are needed in order to improve outcomes after surgery such as negative pressure therapy.

The main objective is to determine the SSI differences depending on the use of negative pressure therapy after infected mesh removal.

Material and methods: multicentric, prospective, randomized and an open comparative study. Patients will be selected sequentially n=94. Each selected patient will be randomized in two groups: conventional closure of the surgical wound vs. negative pressure therapy with a 30-day follow-up.

Detailed description: The surgeon will not know the patient's arm of study before the operation. Once the wound will be closed, we will let know what kind of closure the patient will need. Negative pressure therapy will be the same in all patients, in order to mantain homogeneity.

We will set appointments each day while he is hospitalized, and after the discharge: at 7 (+/- 1) and 30 (+/- 5).

We will collect demographic data before and during surgery, as well as in the postoperative period, including appointments.

Eligibility criteria: Inclusion Criteria:

* Any gender, adult. Age minimum limits 18.
* Infected chronic mesh.
* Signing of informed consent.

Exclusion Criteria:

* Enterocutaneous fistula or enteroatmospheric fistula.
* Infected chronic mesh related to parastomal hernia.
* Patients who will no complete the follow-up period.
* Informed consent denial.

Primary outcomes:
measure: Surgical site infection
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06964386: Effect of Specially Designed Balance Board on Standing Balance in Children With Diplegic Cererbral Palsy
Official title: Effect of Specially Designed Balance Board on Standing Balance in Children With Diplegic Cererbral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Balance Board
Standing Balance
Diplegic Cerebral Palsy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-05-09
Enrollment: 40
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This was done to:

1. To determine the effect of a specially designed balance board on balance ability.
2. To determine the effect of the traditional balance training program on balance ability.
3. To compare between the effect of a specially designed balance board and the traditional balance training program on balance ability.

Detailed description: Children with cerebral palsy (CP) often experience abnormal posture, loss of motor control, and poor trunk control, leading to limitations in daily activities. Improving balance abilities is crucial for maintaining equilibrium in sensory environments. Vestibular stimulation can help develop feed-forward mechanisms and new functional skills. This study aims to improve balance abilities in children with diplegic CP, explore the impact of balance boards on vestibular and hand function, and assist mothers in their child's improvement.

Eligibility criteria: Inclusion Criteria:

1. Their ages ranged from 4 to 8 years old.
2. The degree of spasticity ranged from grade 1 or 1+ according to Modified Ashworth Scale
3. They were at level I or II on gross motor function classification scale.
4. They were able to follow verbal command or instructions.

Exclusion Criteria:

Children were excluded if they had one of the following :

1. Fixed deformities of lower limbs.
2. Visual or auditory problems.
3. History of surgical interference in lower limbs less than six months.
4. Botulinum toxin injections to the lower limb during the previous 4 months.
5. Mental retardation.
6. Fixed deformity

Primary outcomes:
measure: assessment of degree of spasticity
timeFrame: at baseline and after 3 months
Secondary outcomes:
measure: Assessment of change of gross motor function level
timeFrame: at baseline and after 3 months
measure: assessment of change of balance
timeFrame: at baseline and after 3 months
measure: assessment of change of pediatric balance
timeFrame: at baseline and after 3 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: out-patient clinic, faculty of physical therapy, Cairo university
Study officials:
References:
Clinical trial NCT02075086: Angiogenic Switch in Patients With Colorectal Cancer
Official title: Angiogenic Switch as Predictor of Response to Chemotherapy in Patients With Metastatic Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Colorectal Cancer
Keywords: angiogenic switch
plasma cytokines
Colon cancer
Lead sponsor: Grupo Hospital de Madrid
Sponsor class: OTHER
First posted: 2014-03-03
Enrollment: 100
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: A group of colorectal cancer (CRC) patients treated with chemotherapy and Bevacizumab (Bev) maintain the same sensitivity after progression to maintenance treatment because they remain dependent on VEGF angiogenic mediator, while other patients in whom there is an angiogenic switch (AS) become dependent on other angiogenic cytokines and become resistant to Bev chemotherapy combinations .


Eligibility criteria: Inclusion Criteria:

* Diagnosis of stage IV colorectal adenocarcinoma.
* Age ≥ 18 years .
* Measurable disease by RECIST criteria.
* Life expectancy ≥ 6 months.
* Candidate to receive treatment with first-line chemotherapy.
* Availability of tumor tissue.

Exclusion Criteria:

* Patients who have received prior treatment with first-line chemotherapy for metastatic disease.
* Patients in whom there is contraindication to the administration of either drug used in the study: capecitabine, irinotecan, oxaliplatin or Bev.
* Patients receiving anticoagulant oral treatment.
* Patient with diagnosis of other malignancies within 5 years prior to diagnosis except basal cell carcinoma or cervical carcinoma · in situ. · The inclusion of patients with malignant disease diagnosed more than 5 years ago without recurrence in the previous 3 years will be analyzed individually
* Patients with bone disease as the only manifestation of the disease.

Primary outcomes:
measure: Progression Free Survival
timeFrame: 1 year
Secondary outcomes:
measure: Feasibility
timeFrame: 2 years
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Centro Integral oncológico Clara Campal
Study officials:
affiliation: Grupo Hospital de Madrid
name: Antonio Cubillo, MD PhaD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04062786: Postoperative Renal Failure in Cardiac Surgery PMSF-PVC Gradient Study
Official title: Postoperative Renal Failure in Cardiac Surgery PMSF-PVC Gradient Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Scheduled Heart Surgery
Valve Replacement
Coronary Artery Bypass
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2019-08-20
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Major patient with scheduled heart surgery

Brief summary: Acute renal failure is a frequent and severe postoperative complication of cardiac surgery performed under extracorporeal circulation.

It is an independent risk factor for mortality and significantly increases the length of hospital stay.

The origin of renal insufficiency after extracorporeal circulation is multifactorial (long duration of extracorporeal circulation, hemodynamic instability per and post-extracorporeal circulation, prolonged hypotension, transfusion ...).

Nevertheless, an entirely different pathophysiological mechanism, though not recent, is less often mentioned but shows renewed interest. This is the concept of renal venous congestion which may be responsible for impaired renal function in the absence of cardiac dysfunction. Based on Guyton's circulatory model, the investigators approach this systemic venous hypertension through the measurement of the Pmsf-PVC gradient.


Eligibility criteria: Inclusion Criteria:

* age\> 18 years
* subject having signed an informed consent
* scheduled heart surgery:

  * Valve replacement
  * Coronary artery bypass

Exclusion Criteria:

* Any urgent surgery or redux
* Severe preoperative chronic renal failure (stage III) defined by GFR \<30ml / min
* Existence of rhythm disorders (permanent ACFA) or serious cardiac conduction disorders, patients with Pacemaker
* Preoperative alteration of left ventricular ejection fraction with LVEF \<40%
* Major haemodynamic instability with refractory shock defined by dobutamine ≥10μg / kg / min and / or norepinephrine ≥ 1μg / kg / min and / or epinephrine ≥ 0.2μg / kg / min.
* Intra-aortic versus assisted pelvic balloon
* Contraindication to femoral arterial catheterization
* Subject under the protection of justice, subject under guardianship or under tutorship
* Impossibility of giving the subject informed information (subject in emergency situation, difficulties in understanding the subject)

Primary outcomes:
measure: Evolution of the gradient Pmsf (arm) -PVC
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Les Hôpitaux Universitaires de Strasbourg
Study officials:
References:
Clinical trial NCT06420986: Open Hemorrohoidectomy Vs Transanal Hemorrhoidal Desarterialization in Hemorrhoids Grade III: The Effect on Symptoms
Official title: Open Hemorrohoidectomy Versus Transanal Hemorrhoidal Desarterialization in Hemorrhoids Grade III: The Effect on Symptons: An Open-label Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemorrhoids Third Degree
Keywords: hemorrhoids third degree
botulinum Toxin
Hemorrhoidectomy
Transanal Hemorrhoidal Dearterialization
hemorrhoidal Disease Symptom Score
Lead sponsor: Hospital Son Llatzer
Sponsor class: OTHER
Collaborators: name: Fundació d'investigació Sanitària de les Illes Balears
First posted: 2024-05-20
Enrollment: 50
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: The goal of this clinical trial is to learn if open hemorroidectomy diminishes symptoms compared to transanal hemorrhoidal desarterialization (THD) in patients presenting with hemorrhoids grade III. The main question it aims to answer is:

- Do patients undergoing open hemorroidectomy present with lesser symptoms 1 year after surgery, compared to those undergoing a THD?

Researchers will compare open hemorroidectomy to THD in terms of symptom response one year after the procedure.

Participants will:

* Undergo surgical treatment of hemorroids performed by one of the two techniques: open hemorroidectomy versus THD.
* Fill in symptom forms before and one year after the surgical procedure.
* Attend control visits one week, one month, three months and one year after the surgical procedure.


Eligibility criteria: Inclusion criteria:

* Age older than 18.
* Hemorroids grade III.
* Surgical indication for hemorroid treatment.
* Signed informed consent.

Exclusion criteria:

* Acute hemorroidal disease.
* Previous hemorroidal surgery.
* Concomitant anal fissure.
* Concomitant perianal fistulae.
* Concomitant rectal prolapse.
* Inflamatory bowel disease.
* Anal or colorrectal cancer.

Primary outcomes:
measure: hemorrhoidal disease symptom score
timeFrame: one year
measure: short health scale in hemorrhoidal disease
timeFrame: one year
Secondary outcomes:
measure: postoperative pain
timeFrame: 1 week after surgical procedure
measure: fecal incontinence
timeFrame: baseline and 1 week, 3 months and 1 year after surgical procedure
Other outcomes:
Locations:
city: Palma De Mallorca
country: Spain
facility: Hospital Son Llatzer
state: Illes Balears
Study officials:
References:
Clinical trial NCT04216186: Role of Coenzyme Q in ADHD in Children
Official title: Role of Coenzyme Q in Treatment of Attention Deficit Hyperactivity Disorder in Children
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: ADHD
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2020-01-02
Enrollment: 40
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Role of Coenzyme Q in ADHD in Children

Detailed description: Role of Coenzyme Q in ADHD in Children: will it add a benefit?

Eligibility criteria: Inclusion Criteria:

* Patients with ADHD

Exclusion Criteria:

* Comorbidities like Autism, Anxiety, Obsessive compulsive disorder.

Primary outcomes:
measure: Number of patients with improved CONNERS scale
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Sherief Abd-Elsalam
Study officials:
affiliation: Pediatrics department - Kafr Elsheikh University
name: Fatma G. Abdelkader, Msc
role: PRINCIPAL_INVESTIGATOR
affiliation: Pediatrics department - Kafr Elsheikh University
name: Osama A Elagamy, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Pediatrics department - Kafr Elsheikh University
name: Abeer Salamah, Lecturer
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gamal F, El Agami O, Salamah A. Coenzyme Q10 in the Treatment of Attention Deficit Hyperactivity Disorder in Children: A Randomized Controlled Trial. CNS Neurol Disord Drug Targets. 2022;21(8):717-723. doi: 10.2174/1871527320666211124093345.
Clinical trial NCT03918486: Caretaker vs. Routine Blood Pressure Sphygmomanometer
Official title: Caretaker vs. Routine Blood Pressure Sphygmomanometer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blood Pressure
Lead sponsor: The Cooper Health System
Sponsor class: OTHER
First posted: 2019-04-17
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults ages \> 18 who are having their blood pressure monitored using routine blood pressure sphygmomanometer.

Brief summary: Caretaker vs. routine blood pressure sphygmomanometer

Detailed description: The aim of this study is to: Compare blood pressure obtained using routine blood pressure sphygmomanometer to a non-invasive device that continuously monitors central blood pressure (CareTaker).

Eligibility criteria: Inclusion Criteria:

* Adults ages \> 18 who are having their blood pressure monitored using routine blood pressure sphygmomanometer.

Exclusion Criteria:

* Patients not scheduled to be monitored using blood pressure sphygmomanometer.

Primary outcomes:
measure: Comparing blood pressure using routine blood pressure cuff to that recorded by the Caretaker device.
timeFrame: Length of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Camden
country: United States
facility: Cooper University Hospital
state: New Jersey
Study officials:
References:
Clinical trial NCT02350686: XELOX in Advanced Biliary Tract Carcinoma After Failure of Gemcitabine-based Chemotherapy
Official title: Phase II Study of Second Line Capecitabine Plus Oxaliplatin (XELOX) in Patients With Advanced Biliary Tract Carcinoma After Failure of Gemcitabine-based Chemotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Biliary Tract Cancer
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2015-01-30
Enrollment: 67
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: Phase II study of second line capecitabine plus oxaliplatin (XELOX) in patients with advanced biliary tract carcinoma after failure of gemcitabine-based chemotherapy.

Detailed description: XELOX

* Xeloda, 1000mg/㎡ bid, day 1-15, every 3 weeks
* Oxaliplatin 130mg/㎡, day 1, every 3 weeks Until disease progression, patient's refusal or up to 8 cycles (maximum).

Eligibility criteria: Inclusion Criteria:

1. age ≥ 18
2. histologically or cytologically confirmed adenocarcinoma of biliary tract (intrahepatic, extrahepatic cholangiocarcinoma, gall bladder cancer and ampulla of Vater cancer)
3. unresectable or metastatic
4. progression after treatment with first line gemcitabine-based chemotherapy
5. ECOG performance status of 0\~2
6. measurable or evaluable lesion per RECIST 1.1 criteria
7. adequate marrow, hepatic, renal and cardiac functions

Exclusion Criteria:

1. severe co-morbid illness or active infections
2. pregnant or lactating women
3. History of documented congestive heart failure, angina pectoris requiring medication, evidence of tranasmural myocardial infarction on ECG, poorly controlled hypertension, clinically significant valvular heart disease or high risk of uncontrollable arrhythmia
4. active CNS metastases not controllable with radiotherapy or corticosteroids
5. known history of hypersensitivity to study drugs

Primary outcomes:
measure: Progression-free survival
timeFrame: 12months
Secondary outcomes:
measure: response rate
timeFrame: 12months
measure: duration of response
timeFrame: 12months
measure: overall survival
timeFrame: 12months
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: 24months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References: