louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01239628: A Prospective, Non-interventional Survey to Evaluate Injection Intervals and Treatment Modalities of Botulinum Toxin A (BoNT-A) in Adult Patients Suffering From Upper Limb Spasticity After Stroke
Official title: A National, Prospective, Non-interventional Survey to Evaluate Injection Intervals and Treatment Modalities up to 3 Years Follow up of Botulinum Toxin A in Adult Subjects Suffering From Upper Limb Spasticity Post-CVA (Cerebrovascular Accident)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Upper Limb Spasticity After Stroke
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2010-11-11
Enrollment: 45
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 with a history of stroke, suffering from upper limb spasticity

Brief summary: The purpose of the protocol is to evaluate injection intervals and treatment modalities up to 3 years follow-up of botulinum toxin A (BoNT-A) in adult patients suffering from upper limb spasticity after stroke.


Eligibility criteria: Inclusion Criteria:

* Subject able to comply with the protocol
* Provision of written informed consent prior to collecting the data
* Male or female patients of 18 years or older
* Presenting with upper limb spasticity after stroke for which treatment with botulinum toxin A is indicated

Exclusion Criteria:

* The subject has already been included in this survey
* Patients who already received BoNT-A treatment for upper limb spasticity
* Patients with known intolerance for BoNT-A
* Subjects unable to comply with the protocol

Primary outcomes:
measure: Documentation of the injection intervals
timeFrame: 3 years
measure: Documentation of treatment modalities
timeFrame: 3 years
Secondary outcomes:
measure: Documentation of the main reason(s) for change in injection intervals
timeFrame: 3 years
measure: Documentation of the main reason(s) for dose change(s)
timeFrame: 3 years
measure: Documentation of the patient satisfaction with the treatment
timeFrame: 3 years
measure: Documentation of the physician satisfaction with the treatment
timeFrame: 3 years
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: St- Augustinus
city: Antwerpen
country: Belgium
facility: ZNA Middelheim
city: Brugge
country: Belgium
facility: AZ St-Jan
city: Edegem
country: Belgium
facility: RevalidatieZiekenhuis RevArte
city: Gent
country: Belgium
facility: AZ Sint Lucas
city: Herk-de-Stad
country: Belgium
facility: Revalidatiecentrum St Ursula
city: Lanaken
country: Belgium
facility: ZOL, Campus Sint Barbara
city: Lier
country: Belgium
facility: Heilig Hart Ziekenhuis
city: Lodelinsart
country: Belgium
facility: Hôpital Marie Curie
city: Montigny-le-Tilleul
country: Belgium
facility: CHU Leonardo da Vinci
city: Verviers
country: Belgium
facility: CHPLT Peltzer
Study officials:
affiliation: Ipsen
name: Medical Director, Neurology
role: STUDY_DIRECTOR
References:
Clinical trial NCT06479928: Interactions Between Environmental Exposures and Gut Microbiota in Early Life
Official title: The Mechanism of Interaction Between Arsenic Exposure and Gut Microbiota in Infants During Early Life
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Infant Development
Keywords: environmental exposure
gut microbiota
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2024-06-28
Enrollment: 756
Sex: ALL
Minimum age (years): 1
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant woman registered in Peking University People's Hospital will plan to give birth in the hospital.

Brief summary: Recruit the mothers and their infants who bron in Peking University People's Hospital from 2023 to 2026, to evaluate the interaction between environmental exposure and gut microbiota.


Eligibility criteria: Inclusion Criteria:

1. Pregnant woman

   * aged 20-40 years old
   * natural conception
   * single pregnancy
   * gestational age ≥36 weeks
2. Newborn

   * normal Apgar score
   * no serious congenital diseases

Exclusion Criteria:

-

Primary outcomes:
measure: Arsenic levels and Gut microbiota
timeFrame: Pregnancy (12, 24, 36 weeks) and infants (born, 1 week, and 1, 3, 6, 12, 24 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: The Peking University People's Hospital
Study officials:
References:
Clinical trial NCT02518828: High Versus Low SpO2 Oxygen Therapy in Patients With Acute Heart Failure
Official title: High Versus Low SpO2 Oxygen Therapy in Patients With Acute Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Acute Heart Failure
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: Heart and Stroke Foundation of Canada
name: Alberta Innovates Health Solutions
First posted: 2015-08-10
Enrollment: 50
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: The primary objective of this pilot trial is to determine whether inpatients presenting to the Emergency Department (ED) with symptoms suggestive of Acute Heart Failure (AHF), who receive supplemental oxygen adjusted at either a high (SpO2 range ≥96%) or low (SpO2 range 90-92%) oxygen saturation level, leads to greater reduction in N-terminal-proBNP (NT-proBNP) at 72 hours.

Detailed description: Patients will be randomized to either a high (SpO2 range ≥96%) or low (SpO2 range 90-92%) oxygen after informed consent.

Eligibility criteria: Inclusion Criteria:

* \>40 years of age presenting to the ED with AHF
* objective finding of HF (BNP \>400 pg/ml or Chest X-Ray with pulmonary congestion)
* plan to admit with primary diagnosis as HF
* must be able to be randomized within 16 hours of presenting to the ED
* provided written informed consent

Exclusion Criteria:

* on home oxygen
* known prior hypercapnic failure (PaCO2 \>50 mmHg)
* asthma
* primary pulmonary hypertension,
* patients who require urgent positive pressure ventilation or intubation
* patients on \>10 L/min oxygen

Primary outcomes:
measure: Change in NT-proBNP from baseline to 72 hours
timeFrame: 72 hours
Secondary outcomes:
measure: Change in dyspnea using the visual analog scale (VAS) from baseline to 72 hours
timeFrame: 72 hours
measure: Change in global symptoms using the Patient Global Assessment scale (PGA) from baseline to 72 hours
timeFrame: 72 hours
measure: Change in Peak Expiratory Flow Rate (PEFR) from baseline to 72 hours
timeFrame: 72 hours
measure: Number of worsening heart failure (WHF) events
timeFrame: 7 days
measure: 30-day clinical events
timeFrame: 30 days
measure: Average z-score from the combination of these outcomes: PGA, NT-proBNP, 7-day WHF, 30-day mortality and re-hospitalization
timeFrame: 30 days
measure: Hochberg endpoint (combination of NT-proBNP and PGA)
timeFrame: 72 hours
measure: Diuretic response (weight loss up to 72 hours and urine volume up to 24 hours)
timeFrame: 72 hours
Other outcomes:
measure: Safety Outcome - Need for mechanical ventilation (invasive and non-invasive
timeFrame: 7 days
Locations:
city: Edmonton
country: Canada
facility: University of Alberta Hospital / Mazankowski Alberta Heart Institute
state: Alberta
Study officials:
affiliation: University of Alberta
name: Justin Ezekowitz, MBBCH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05345028: Boswellia Serrata Extract in Acute Diarrhea
Official title: Positive Effects of a Lecithin-based Delivery Form of Boswellia Serrata Extract in Acute Diarrhea of Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Diarrhea
Boswellia Serrata
Lead sponsor: Azienda di Servizi alla Persona di Pavia
Sponsor class: OTHER
First posted: 2022-04-25
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Acute diarrhea is a frequent problem worldwide, mostly due to gastrointestinal infections or food poisoning. Boswellia serrata could be active in the treatment of acute diarrhea due to its an-ti-inflammatory, antispasmodic and antimicrobial activity.


Eligibility criteria: Inclusion Criteria:

* presence of acute diarrhea of mild to moderate severity

Exclusion Criteria:

* patients with long term diarrhea
* iatrogenic diarrhea
* symptoms of functional gut disease or severe inter-current diseases
* severe diarrhea and dehydration requiring hospitalization and intravenous treatment
* subjects with high temperature (\> 38.5° C)
* subjects treated by other anti-diarrheal and antibiotic drugs in the last 24 hours
* severely malnourished subjects
* pregnant women

Primary outcomes:
measure: Stoppage of diarrhea
timeFrame: From baseline to 5 days
Secondary outcomes:
measure: Self-assessed symptoms
timeFrame: After 5 days
measure: Self-assessed symptoms
timeFrame: After 5 days
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Azienda di Servizi alla Persona
Study officials:
References:
Clinical trial NCT04822428: Effect of Visceral Osteopathic Manipulations on Low Back Pain
Official title: Effect of Visceral Osteopathic Manipulations on Low Back Pain Caused by Visceral Dysfunctions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-03-30
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized, controlled, parallel study
Primary purpose: SUPPORTIVE_CARE

Brief summary: Forty female patients with age ranging from 30-40 years old were suffering from low back pain due to visceral dysfunctions participated in this study. They were recruited from a private clinic. They were assigned into two groups equal in number; Group (A): included twenty patients who received osteopathic manipulative techniques, 1 session per week for 3 weeks, and Group (B): included twenty patients who received only analgesic drugs.

Detailed description: Twenty patients received osteopathic manipulative techniques including Suboccipital release technique, diaphragmatic release.,mesentery release and Colonic manipulation were applied to the study group according to the patients' needs.

The treatment program comprised a total of 3 sessions for 3 weeks at one session per week for an average of 50 minutes per session. Twenty patients in the second group (control ) took only analgesics during the three weeks.

Eligibility criteria: Inclusion Criteria:

* Non-specific low back pain for more than 12 weeks

Exclusion Criteria:

* Malignant tumor
* Pregnancy
* Acute ischemic bowel disease,
* Intestinal obstruction,
* surgery in the last six months

Primary outcomes:
measure: The visual analog scale (VAS)
timeFrame: change from baseline to after 3 weeks
measure: The Oswestry Disability Index (ODI)
timeFrame: change from baseline to after 3 weeks
measure: Modified Schober's test (MST)
timeFrame: change from baseline to after 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Physical Therapy
Study officials:
References:
Clinical trial NCT06117228: Gynaecological Follow-up of Women With Down Syndrom Aged 18 to 30 in France
Official title: Gynaecological Follow-up of Women With Down Syndrom Aged 18 to 30 in France
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Down Syndrome
Keywords: Gynaecological follow-up
down syndrome
women
Lead sponsor: Université de Reims Champagne-Ardenne
Sponsor class: OTHER
First posted: 2023-11-03
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women with Down syndrome, aged 18 to 30, whether or not they are being followed up in medical facilities in France.

Brief summary: Gynaecological check-ups for women are recommended in France. However, some groups of the population are affected by a lack or absence of medical surveillance.

In France, there are one million people with an intellectual disability, including 50,000 with Down syndrome.

Although this disability causes numerous physical and psychological deficits, no gynaecological consequences have yet been demonstrated.

Regular gynaecological check-ups are therefore necessary, according to French recommendations.

However, several studies have shown that women with mental illness receive less or no gynaecological care.

Detailed description: The aim is to describe the gynaecological follow-up of women with Down syndrom in France.

Eligibility criteria: Inclusion Criteria:

* women with Down's syndrome,
* aged between 18 and 30,
* whether or not they are being followed up in a medical facility,
* who agree to take part in the study.

Exclusion Criteria:

* women with a disability other than Down's syndrome
* Not agreeing to take part in the study

Primary outcomes:
measure: Gynaecological follow-up
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Reims
country: France
facility: Ufr Medecine Urca
Study officials:
affiliation: Université de Reims Champagne-Ardenne
name: Muller Gaëlle
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00213928: Horse Chestnut Seed Extract for Lymphedema
Official title: A Single-blind, Randomized Trial of Horse Chestnut Seed Extract for the Treatment of Lymphedema of the Arm in Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lymphedema of Arm
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 56
Sex: FEMALE
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To help Treat Lymphedema of the Arm in Breast Cancer Survivors with Horse chestnut Seed Extract

Detailed description: The objectives of this study are to evaluate the effectiveness of escin (as horse chestnut seed extract) for arm lymphedema in women following treatment for breast cancer, to evaluate the accuracy and sensitivity of bioelectric impedance as a measurement of lymphedema of the arm, and to validate the proposed arm lymphedema quality-of-life questionnaire.

Eligibility criteria: Inclusion Criteria:

* Patient demonstrates unilateral (ipsilateral to breast cancer resection side) lymphedema of the upper extremity. An extravascular water ratio of ³1.1/1 between the affected vs normal arm using multiple-frequency bioelectric impedance will be used as a criterion for lymphedema. There is not upper limit to the extent of arm volume (lymphedema)
* Patient is greater than 6 months from last surgical and/or radiation treatment to the affected axilla.

Exclusion Criteria:

* Patients may not be receiving or be scheduled to receive cytotoxic or radiation chemotherapy treatment while on this lymphedema study (Last chemotherapy \> 4 weeks prior). Women who are being treated adjuvantly with tamoxifen, raloxifene, or an aromatase inhibitor remain eligible
* Patients with a history of recurrent (more than 1 episode) arm cellulitis, prior or existing venous clot, or considered to have "woody" fibrosis of the affected arm are not eligible. Antibiotics used to treat any prior episode of cellulitis must have be completed no more recently than 3 months prior to initial screening.

Primary outcomes:
measure: Reduction of arm lymphedema
Secondary outcomes:
measure: - comparison of bioelectric impedance to measure lymphedema changes
measure: - validation of bioelectric impedance to measure lymphedema changes
measure: - validation of lymphedema questionnaire
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Paul R Hutson, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06457828: Effect of Apical Patency and Local Corticosteroid on Pain and Neuropeptides Release in Patients With Symptomatic Irreversible Pulpitis: A Randomized Clinical Trial
Official title: Effect of Apical Patency and Local Corticosteroid on Pain and Neuropeptides Release in Patients With Symptomatic Irreversible Pulpitis: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postoperative Pain
Symptomatic Irreversible Pulpitis
Keywords: Pulpitis
Postoperative Pain
VAS
Lead sponsor: Suez Canal University
Sponsor class: OTHER
First posted: 2024-06-13
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The goal of this randomized clinical trial is to learn the effect of using local corticosteroids and maintaining apical patency in reducing post-preparation pain in patients with acute irreversible pulpitis in molar teeth. The main question it aims to answer is:

• How effective are using local corticosteroids and maintaining apical patency in reducing post-preparation pain in patients with acute irreversible pulpitis? Participants will be asked to fill a visual analogue scale to record their pain, after receiving a root canal treatment while using local corticosteroids or not as well as maintaining apical patency or not.

Researchers will compare the use of corticosteroids and maintaining apical patency in reducing post-operative pain.


Eligibility criteria: Inclusion Criteria:

* Symptomatic acute irreversible pulpitis in molar teeth.
* Normal periapical condition including periapical radiography with minimal widening of periodontal ligament.
* Normal probing depth.
* No medical condition.
* No contraindication for administration of corticosteroids and local anesthesia.

Exclusion Criteria:

* Facial or oral paresthesia.
* Pregnancy \& breastfeeding.
* Unrestorable tooth.
* Marginal periodontal disease.
* Presence of a crown on the tooth involved.
* Over instrumentation during root canal treatment.
* Long-term use of corticosteroids.
* False-positive cases of sensibility test with necrosis discovered after gaining access to the tooth.
* Cases requiring intrapulpal injection to promote anesthesia.

Primary outcomes:
measure: Post-operative pain
timeFrame: 6, 12, 24, 48, 72 hour and 7 days postoperative intervals
measure: Inflammatory markers
timeFrame: before treatment, after 3 days and after 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Ismailia
country: Egypt
facility: Suez Canal University
Study officials:
References:
Clinical trial NCT00221793: Weight Changes in Parkinsonian Patients, Treated With Deep Brain Stimulation
Official title: Study of Ponderal Load in Parkinsonian Patients After Deep Brain Stimulation of the Subthalamic Nucleus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson
deep subthalamic stimulation
pharmacological treatment
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2005-09-22
Enrollment: 20
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this trial is to verify that neurostimulated parkinsonian patients gain weight and to study its link with an energetic balance change.

Detailed description: The aim of this trial is to verify that neurostimulated parkinsonian patients gain weight and to study its link with an energetic balance change.

Twenty parkinsonian patients will be randomised : the delay between inclusion and neurostimulation wil be lengthened 3 months for one group, compared to the second one. The energy expenditure, at rest and after ingestion of a test meal, will be compared between the group of patients that had been neurostimulated and the group whose intervention has been postponed. Weight changes, energy intake, leptin level, neurophysiological parameters will be compared between both groups, and the nature and repartition of the weight gain will be assessed in the neurostimulated group. An eventual link between motor factors, pharmacological factors, and gain weight will be studied.

Eligibility criteria: Inclusion Criteria:

* Age between 35 and 70; male or female; parkinson disease, with levo dopa response (at least 30%); severe but stable incapacity; no dementia, no psychosis, no depression; normal brain scanner done during the last 2 years.

Exclusion Criteria:

* diabetes thyroid disease pacemaker coagulation troubles previous drug abuse

Primary outcomes:
measure: Measurement of energy expenditure with indirect calorimetry in open chamber: at rest in the morning, without 24h-dopaminergic treatment, and after dopaminergic treatment intake; and post prandial thermogenesis after a test meal.
timeFrame: After surgery and at 3 months
Secondary outcomes:
measure: Weight gain
timeFrame: At visit 1 and at 3 months
measure: increase of energy intake
timeFrame: At visit 1 and at 3 months
measure: leptin, glucose, insulin blood levels
timeFrame: At visite 1 and at 3 months
measure: cognitive and psychological assessments
timeFrame: before surgery and after 3 months
measure: UDPRS scale
timeFrame: before surgery and after 3 months
Other outcomes:
Locations:
city: Pessac
country: France
facility: Service de neurologie Hôpital Haut-Lévêque
Study officials:
affiliation: Service de neurologie Hôpital Haut-Lévêque Pessac
name: François TISON, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: CIC Inserm-CHU de Bordeaux Pessac
name: Jacques DEMOTES-MAINARD, Pr
role: STUDY_CHAIR
References: