louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00630422: Functional Abilities in Rett Syndrome
Official title: Functional Abilities in Rett Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rett Syndrome
Keywords: Rett Syndrome
Selfcare
Mobility limitation
Interpersonal relations
This study avaliated patients with Rett Syndrome
Lead sponsor: Faculdades Metropolitanas Unidas
Sponsor class: OTHER
Collaborators: name: University of Sao Paulo
First posted: 2008-03-07
Enrollment: 64
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: This study investigated only patients with Rett syndrome that matched the criteria for the classic form of the disease

Brief summary: The purpose of this study is to evaluate and determinate the functional abilities in Rett syndrome conforming to the established Pediatric Evaluation of Disability Inventory (PEDI).

Detailed description: Rett syndrome (RS) is a progressive neurological disturbance of genetic cause that affects females almost exclusively. It is caused by mutations, usually sporadic, of the MECP2 gene located in the X chromosome. In consequence to the serious cognitive and motor compromise, the RS patients have great difficulty in accomplishing day-to-day tasks. The objective of this work is to evaluate the functional abilities in RS to help therapists in theirs treatments programs.

Eligibility criteria: Inclusion Criteria:

* Patients with Rett syndrome that matched the criteria for the classic form of the disease

Exclusion Criteria:

* Any other disease;
* Rett syndrome associated with other disease
* Rett syndrome that not that matched the criteria for the classic form of the disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Faculdades Metropolitanas Unidas
Study officials:
affiliation: Faculdades Metropolitanas Unidas
name: Carlos BM Monteiro, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06147622: A Study to Assess the Pharmacokinetic Profile of Prazosin and Cyproheptadine
Official title: A Phase 1, Open-label, Cross-over Study in Healthy Volunteers to Assess the Pharmacokinetic Profile of Prazosin and Cyproheptadine Following Single Dose Oral Administration of KT110 Tablet and Following Administration of Alpress and Periactin Marketed Tablets
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alcohol Use Disorder
Lead sponsor: Greenpharma S.A.S.
Sponsor class: OTHER
First posted: 2023-11-27
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: open-label, randomized, 2-period, single dose, crossover study
Primary purpose: OTHER

Brief summary: The study is an open-label, randomized,2-period, single dose, crossover study in 8 healthy male/female volunteers. Subjects will be randomized to the following sequences:

(A) Period 1: KT110 - wash-out period - Period 2: Alpress and Periactin marketed tablets ; Or (B) Period 1: Alpress and Periactin marketed tablets - wash-out period - Period 2: KT110


Eligibility criteria: Inclusion Criteria:

* Healthy male/female subject
* Females of childbearing potential and male participant must agree to use an adequate and highly effective method of contraception
* Negative serum pregnancy test at screening for woman of childbearing potential only
* Non-smoker subject or smoker of not more than 5 cigarettes a day
* Body Mass Index (BMI) between 18.5 and 30 kg/m2 inclusive, at screening

Exclusion Criteria:

* Any contraindication to Prazosin or Cyproheptadine treatments;
* Frequent headaches and / or migraine, recurrent nausea and / or vomiting;
* Symptomatic hypotension whatever the decrease of blood pressure or asymptomatic postural hypotension defined by a decrease equal to or greater than 20 mmHg in systolic blood pressure (SBP) and a decrease equal to or greater than 10 mmHg in diastolic blood pressure (DBP) within two minutes of changing from supine to standing position;
* Blood donation (including as part of a clinical trial) in the 2 months before administration
* Any drug intake (except paracetamol or contraception) during the month prior to the first administration;
* History or presence of drug or alcohol abuse (alcohol consumption \> 40 grams / day)
* Excessive consumption of beverages with xanthine bases (\> 4 cups or glasses / day);
* Positive Hepatitis B surface (HBs) antigen or anti Hepatitis C Virus (HCV) antibody, or positive results for Human Immunodeficiency Virus (HIV) 1 or 2 tests
* Positive results of screening for drugs of abuse

Primary outcomes:
measure: AUC (area under the curve) 0-t
timeFrame: Day 4
measure: AUC 0-inf
timeFrame: Day 4
measure: Cmax
timeFrame: Day 4
measure: Tmax
timeFrame: Day 4
measure: T1/2
timeFrame: Day 4
measure: K el
timeFrame: Day 4
Secondary outcomes:
Other outcomes:
Locations:
city: Gières
country: France
facility: Eurofins Optimed
Study officials:
References:
Clinical trial NCT04417322: Serum A.Actinomycetemcomitans Antibodies and Periodontitis
Official title: Association Among Serum A.Actinomycetemcomitans Antibodies and Periodontitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Periodontal Diseases
Lead sponsor: University of Messina
Sponsor class: OTHER
First posted: 2020-06-04
Enrollment: 221
Sex: ALL
Minimum age (years): 34
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 53 patients with periodontitis and 48 healthy subjects (HS) were enrolled in the present study. Enrolled patients were examined and characterized for clinical and blood samples analysis, andA.actinomycetemcomitans antibodies were expressed and evaluated enzyme-linked immunosorbent assay (ELISA) units (EU).

Brief summary: The aim of this study was to analyze the association between serum A.actinomycetemcomitans antibodies in patients with periodontitis. Furthermore, the objective was to determine if the periodontitis influenced serum IgG A.actinomycetemcomitans antibodies levels

Detailed description: 53 patients with periodontitis and 48 healthy subjects (HS) were enrolled in the present study. Enrolled patients were examined and characterized for clinical and blood samples analysis and A.actinomycetemcomitans antibodies were expressed and evaluated enzyme-linked immunosorbent assay (ELISA) units (EU). The Spearman Correlation Test and Jonckheere-Terpstra Test were applied in order to assess the interdependence between serum IgG A.actinomycetemcomitans antibodies and clinical periodontal parameters.

Eligibility criteria: Inclusion Criteria:

* Presence of at least 15 teeth
* CP with a minimum of 40% of sites with a clinical attachment level (CAL)

  ≥2mm and probing depth (PD) ≥4mm;
* Presence of at least ≥2 mm of crestal alveolar bone loss verified on digital periapical radiographs
* Presence of ≥40% sites with bleeding on probing (BOP)

Exclusion Criteria:

* Intake of contraceptives
* Intake of immunosuppressive or anti-inflammatory drugs throughout the last three months prior to the study
* Status of pregnancy or lactation
* Previous history of excessive drinking
* Allergy to local anaesthetic
* Intake of drugs that may potentially determine gingival hyperplasia such as Hydantoin, Nifedipine, Cyclosporin A or similar drugs.

Primary outcomes:
measure: Clinical Attachment Level
timeFrame: 1-year
Secondary outcomes:
Other outcomes:
Locations:
city: Messina
country: Italy
facility: University of Messina
Study officials:
affiliation: University of Messina
name: Giovanni Matarese
role: STUDY_CHAIR
References:
citation: Isola G, Polizzi A, Patini R, Ferlito S, Alibrandi A, Palazzo G. Association among serum and salivary A. actinomycetemcomitans specific immunoglobulin antibodies and periodontitis. BMC Oral Health. 2020 Oct 15;20(1):283. doi: 10.1186/s12903-020-01258-5.
Clinical trial NCT00468039: A Sub-study to LMF237A2302 to Assess the Effect of 24 Weeks Treatment With Initial Combination of Vildagliptin Plus Metformin
Official title: A Multicenter, Open-label Sub-study to LMF237A2302 to Assess the Effect of 24 Weeks Treatment With Initial Combination of Vildagliptin 100mg qd Plus Metformin 1000mg Bid in Drug Naive Patients With Type 2 Diabetes With Very Poor Glycemic Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Keywords: metformin
vildagliptin
initial combination
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-05-01
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the effects of treatment with vildagliptin and metformin as initial combination in newly diagnosed patients with type 2 diabetes who have very high levels of HbA1c and/or fasting plasma glucose.


Eligibility criteria: Inclusion Criteria:

* Male or female (non-fertile or of childbearing potential using a medically approved birth control method) patients with type 2 diabetes
* Diagnosis of type 2 diabetes for at least 4 weeks prior to study entry
* Body mass index 22-40 kg/meter squared
* HbA1c \> 11% and/or FPG \>270 mg/dL

Exclusion Criteria:

* Pregnant or lactating female
* History of type 1 diabetes
* Evidence of significant diabetic complications
* Treatment with insulin or any other oral antidiabetic agent

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: glycosylated hemoglobin (HbA1c)at Baseline and week 24
timeFrame: 24 weeks
Secondary outcomes:
measure: HbA1c at Baseline and week 12
timeFrame: 12 weeks
measure: Fasting plasma glucose test (FPG) at Baseline and week 24
timeFrame: 24 weeks
measure: Weight at baseline and week 24
timeFrame: 24 weeks
measure: Responder rates assessed by HbA1c absolute reduction from baseline to endpoint greater than or equal to 0.7% after 24 weeks
timeFrame: 24 weeks
measure: Safety assessed by monitoring and recording all adverse events, serious adverse events.
timeFrame: 24 weeks
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Diabetes and Glandular Disease Research Associates
state: Texas
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Bosi E, Dotta F, Jia Y, Goodman M. Vildagliptin plus metformin combination therapy provides superior glycaemic control to individual monotherapy in treatment-naive patients with type 2 diabetes mellitus. Diabetes Obes Metab. 2009 May;11(5):506-15. doi: 10.1111/j.1463-1326.2009.01040.x. Epub 2009 Mar 23.
Clinical trial NCT04102839: PWS Outcomes Assessment Study
Official title: PWS Outcome Assessment Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prader-Willi Syndrome
Keywords: Prader-Willi Syndrome
PWS
Lead sponsor: Soleno Therapeutics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Casimir Trials
First posted: 2019-09-25
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: FAMILY_BASED
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Caregivers of PWS patients who are participating in Soleno C601 and C602 Clinical Studies.

Brief summary: This is a longitudinal study during which qualitative interviews will be conducted with caregivers of Soleno C601/C602 study subjects. There is an additional option for caregivers to collect video data of PWS patients doing specific activities of daily life.

The purpose of this study is to understand the real-world and nuanced impact of a potential therapeutic on individual PWS patients. The results of this study will complement the outcomes being captured during the Soleno C601/C602 clinical studies.

There is no treatment or intervention associated with this study.


Eligibility criteria: Inclusion Criteria:

Key Inclusion Criteria for Interviews:

Eligible caregivers must:

* Be willing and able to provide informed consent in English
* Care for a C601/C602 trial subject or potential trial subject
* Have access to a smartphone or the internet
* Be able to converse in English

Key Inclusion Criteria for Video Capture:

Eligible PWS participants for the optional daily life video capture must:

* Be willing and able to provide informed consent or assent.
* Be enrolled in the C601/C602 trial
* Be able to converse in English
* Have a caregiver who has access to an Apple or Android smartphone or has internet access and is willing to use a wi-fi-only device to record and upload videos
* Have a caregiver who is willing and able to record activity videos

Exclusion Criteria:

* n/a

Primary outcomes:
measure: Meaningful Change in Symptom Categories
timeFrame: From baseline for interview #2 (Week 13-16), From baseline for interview #3 (Week 26-28), From baseline for interview #4 (Week 65-67)
Secondary outcomes:
Other outcomes:
Locations:
city: Plymouth
country: United States
facility: Casimir Trials
state: Massachusetts
Study officials:
References:
Clinical trial NCT01588639: To Evaluate Clinical Outcome and Injection Compliance of Scilin
Official title: A Prospective Multi-centre, Non-randomized, Open-label, Non-interventional Study to Evaluate the Safety, Efficacy and Injection Compliance of Scilin N, Scilin R or Scilin M30 in Chinese Type 2 Diabetes Mellitus (T2DM)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Keywords: Recombinant human insulin
T2DM
Safety
Efficacy
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2012-05-01
Enrollment: 2683
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinic

Brief summary: This is a prospective, multi-center, open-label, non-interventional, 12-week study in people with type 2 diabetes mellitus who are treated with recombinant human insulin-SciLin N, SciLin R and SciLin M30 (alone or in combination) in routine clinical practice. The term study insulins will be used in this protocol for these drugs and combinations.


Eligibility criteria: Inclusion Criteria:

* Based on physicians' clinical judgement, subjects who are treated with SciLin N, SciLin R and SciLin M30 ( alone or in combination) will be eligible to be included in this clinical study.

Exclusion Criteria:

Subjects with one of the conditions listed below will be excluded:

Women who are pregnant, breast feeding or have the intention of becoming pregnant within the next 6 months Subjects who have to be treated with other insulins simultaneously Subjects who are participating in other diabetes clinical studies at the same time

Primary outcomes:
measure: Occurrence rate of serious adverse drug reactions including severe hypoglycaemic events
timeFrame: up to 12 week
Secondary outcomes:
measure: Occurrence rate of hypoglycemic events
timeFrame: up to 12 weeks
measure: Change in HbA1c
timeFrame: Baseline and week 12
measure: Change in FPG (Fasting Plasma Glucose)
timeFrame: Baseline and week 12
measure: Change in PPG (Postprandial Glucose)
timeFrame: Baseline and week 12
measure: The ratio of compliance injection (following physician's advice)
timeFrame: up to 12 weeks
measure: Number and ratio of missed injections
timeFrame: up to 12 weeks
Other outcomes:
Locations:
city: Many Locations
country: China
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03038139: Postural Correction Exercises for Forward Head Posture
Official title: Changes in Spinal Muscular Activation and Creaniovertebral Angle After Postural Correction Program for Forward Head Posture
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Forward Head Posture
Keywords: forward head posture
postural correction
spinal muscles
Lead sponsor: Imam Abdulrahman Bin Faisal University
Sponsor class: OTHER
First posted: 2017-01-31
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 28
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the changes of spinal muscle activation in cervical, thoracic and lumbar segments for subjects with forward head posture (FHP) after application of two correction programs; a conventional one including cervical and thoracic spine, and a second program involving lumbosacral segment.


Eligibility criteria: Inclusion Criteria:

* adults with craniovertebral angle less than 50◦

Exclusion Criteria:

* Participants will be excluded if they have
* congenital spinal deformity such as scoliosis
* spinal conditions such as cervical trauma, fracture, instability of cervical spine, inflammation, infection, or neurological deficit
* a history of surgery at cervical spine or shoulder
* pregnant woman

Primary outcomes:
measure: Changes of Craniovertebral angle
timeFrame: 4 weeks
Secondary outcomes:
measure: Electromyography
timeFrame: 4 weeks
measure: Neck Disability Index
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Dammam
country: Saudi Arabia
facility: Dammam University
state: Eastern Province
city: Dammam
country: Saudi Arabia
facility: Dammam University
Study officials:
References:
Clinical trial NCT05162339: Inflammatory Bowel Disease and Thromboembolic Events
Official title: Inflammatory Bowel Disease and Thromboembolic Events
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammatory Bowel Diseases
Thromboembolism
Coagulation Disorder
Lead sponsor: Centro Hospitalar Tondela-Viseu
Sponsor class: OTHER
Collaborators: name: Portuguese IBD Group
First posted: 2021-12-17
Enrollment: 149
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 18 years of age or older, diagnosed with IBD (ECCO criteria), and followed at a gastroenterology consultation at Centro Hospitalar Tondela-Viseu

Brief summary: The main objective was to demonstrate the existence and importance of hypercoagulability in patients with IBD, by determining the prevalence of changes in coagulation parameters and evaluating the impact of these changes on the occurrence of thromboembolic events.


Eligibility criteria: Inclusion Criteria:

* Patients with 18 years of age or older, diagnosed with IBD, followed at a gastroenterology consultation at Centro Hospitalar Tondela-Viseu, between November 2016 and April 2017.

Exclusion Criteria:

* Individuals with other risk factors for TE (severe hepatic or renal failure, valvular heart disease, atrial fibrillation, heart failure or cardiomyopathy, pregnancy, and oral anticoagulants or heparin at the baseline).

Primary outcomes:
measure: Prevalence of thromboembolic events in IBD
timeFrame: 36 months
measure: Coagulation parameters variations in IBD
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Viseu
country: Portugal
facility: Centro Hospitalar Tondela Viseu
Study officials:
References:
citation: Carvalho AC, Pinho J, Cancela E, Vieira HM, Silva A, Ministro P. Inflammatory bowel disease and thromboembolic events: a c'lot to learn. Therap Adv Gastroenterol. 2022 May 25;15:17562848221100626. doi: 10.1177/17562848221100626. eCollection 2022.
Clinical trial NCT05202639: Decision-making Regarding the Possibility of Medical Termination of Pregnancy
Official title: Decision-making Regarding the Possibility of Medical Termination of Pregnancy on Two Multidisciplinary Prenatal Diagnosis Centers of Maternities Level 3 in Lyon in 2019
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Medical Termination of Pregnancy
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2022-01-21
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be couples whose files were presented to the Multidisciplinary Prenatal Diagnosis Centers of two level 3 maternity hospitals in Lyon during 2019 for a severe fetal pathology, and for which the authorization of medical termination of pregnancy was delivered.

Brief summary: The aim of this study is to improve professional practices by better understanding parents who face the choice of medical termination of pregnancy.

The hypothesis of the study is that the decision to continue the pregnancy with a serious fetal pathology is more based on the belief and the representations of parents than on the diagnosis or prognosis criteria of the fetus.

A better understanding of the parents' motivations on their decision making by knowing what they expect from the caregivers would allow the division of representations, a better prenatal advice and a better perinatal support.


Eligibility criteria: Inclusion Criteria:

* Adults without age limit
* Couples or single mothers seen at hospital in 2019
* Couples or single mothers who have been taken care at the Antenatal Diagnosis Center
* Couples or single mothers whose file has been presented to a Multidisciplinary Prenatal Diagnosis Center (MPDC)
* MPDC's legal authorization of medical termination of pregnancy for severe fetal pathology (fetal reason)

Exclusion Criteria:

* MPDC's legal authorization of medical termination of pregnancy for maternal reason
* Parents who have requested an opinion on another MPDC (with continuation of care in another center)
* Fetal death in utero before couple's decision to continue or terminate the pregnancy
* Psychiatric pathology preceding the pregnancy
* Non-affiliation to health insurance plan
* No possible communication (language barrier)
* Participation refusal
* Adult patient protected under the terms of the law (Public Health Code)

Primary outcomes:
measure: Quantitative auto-questionnaire (Likert scale)
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Service d'obstétrique et de néonatologie, psychiatrie périnatale - Hôpital de la Croix-Rousse
Study officials:
affiliation: Service d'obstétrique et de néonatologie, psychiatrie périnatale - Hôpital de la Croix-Rousse - Hospices Civils de Lyon
name: Sylvie VIAUX-SAVELON, MD
role: PRINCIPAL_INVESTIGATOR
References: