louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06342557: Transitional ePRO Diary Liver
Official title: Integrated System for Patients Who Belong the Transition to Adult Services and Are Undergoing a Liver Transplant
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Liver Transplant
Lead sponsor: FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS
Sponsor class: OTHER
First posted: 2024-04-02
Enrollment: 250
Sex: ALL
Minimum age (years): 14
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Patients between the ages of 14 and 20 who have been transplanted at the ASST-PG23 transplant center or are awaiting a liver transplant and belong to the transition to adult services.

Brief summary: The study is part of the MACROLIVER Project, whose main objective is to create a digital tool for patients and caregivers for the management of liver disease that allows the optimization of therapy and/or the treatment process, even remotely. Such a tool not only reduces the movement of patients who are by definition fragile, but also enables the optimization of access and care by a multidisciplinary team. This tool is intended to support doctors and patients, but in no way replaces normal clinical practice. This study aims to explore the specificities of patients experiencing the transition from the pediatric ward to the adult ward in order to identify risk and protective factors that influence psychological well-being at both an individual and relational level. In order to gather all the information about the patients attending the transitional clinic and to obtain a more complete and truthful clinical-psychological picture, the study also includes the collection of retrospective data of the transplanted patients.


Eligibility criteria: Inclusion Criteria:

* patients between the ages of 14 and 20 who have been transplanted at the ASST-PG23 transplant center or are awaiting a liver transplant and belong to the transition to adult services
* signed informed consent
* proven use of the APPs (to be assessed based on the last 2 weeks)

Exclusion Criteria:

-

Primary outcomes:
measure: four-item Morisky Medication Adherence Scale (MGLS)
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bergamo
country: Italy
facility: ASST-Papa Giovanni XXIII
state: Milano
Study officials:
affiliation: ASST-PG23
name: Stefano Fagiuoli, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01585857: ADIPOA - Clinical Study
Official title: A Phase I, Prospective, Bi-centric,Single -Arm, Open-label, Dose-escalating Clinical Trial to Evaluate the Safety of a Single Injection of Autologous Adipose Derived Mesenchymal Stromal Cells in the Treatment of Severe Osteoarthritis of the Knee Joint
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Osteoarthritis
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2012-04-26
Enrollment: 18
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Primary:

To study the safety of a single injection of autologous adipose derived mesenchymal stromal cells (ASCs) on patients with moderate or severe osteoarthritis of the knee (OA).

Secondary:

To study the efficacy of a single injection of autologous adipose derived mesenchymal stromal cells on patients with moderate or severe osteoarthritis of the knee (OA).


Eligibility criteria: Inclusion Criteria:

* OA diagnosis should fulfil the criteria of the American College of Rheumatology (ACR) with moderate or severe medial and/ or external femorotibial knee osteoarthritis (OA) (stage 3 or 4) and indication total knee arthroplasty.

Exclusion Criteria:

* Any disease or medication affecting the bone or cartilage metabolism, including corticoids.

Primary outcomes:
measure: Recording of Serious Adverse Events
timeFrame: during 365 days following injection
Secondary outcomes:
measure: Functional status of the knee
timeFrame: during 365 days following injection
measure: Evaluation of Quality of life
timeFrame: during 365 days following injection
Other outcomes:
Locations:
city: Montpellier
country: France
facility: UH Montpellier
city: Würzburg
country: Germany
facility: Orthopädische Klinik
Study officials:
affiliation: University Hospital, Montpellier
name: Christian Jorgensen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pers YM, Rackwitz L, Ferreira R, Pullig O, Delfour C, Barry F, Sensebe L, Casteilla L, Fleury S, Bourin P, Noel D, Canovas F, Cyteval C, Lisignoli G, Schrauth J, Haddad D, Domergue S, Noeth U, Jorgensen C; ADIPOA Consortium. Adipose Mesenchymal Stromal Cell-Based Therapy for Severe Osteoarthritis of the Knee: A Phase I Dose-Escalation Trial. Stem Cells Transl Med. 2016 Jul;5(7):847-56. doi: 10.5966/sctm.2015-0245. Epub 2016 May 23.
Clinical trial NCT05375357: Platelet Rich Fibrin in Soft Tissue Healing After Implant Uncovering
Official title: Evaluation of Healing Time and Postoperative Morbidity After Implant Uncovering With Vestibularly Repositioned Flap Associated With Leucocyte Platelet Rich Fibrin (L-PRF): a Randomized and Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healing Surgical Wounds
Keywords: Platelet Rich Fibrin
Wound Healing
Implant Uncovering
Lead sponsor: G. d'Annunzio University
Sponsor class: OTHER
First posted: 2022-05-16
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study represents a prospective, controlled and randomized clinical trial assessing the effects of L-PRF on the healing time of the donor area and on the patient's postoperative morbidity in the 4 weeks following the Apically Positioned Flap (APF) procedure in the uncovering phase of two-stage implants.

A total of 40 patients were recruited and divided into two groups. The implant uncovering procedure in the test group was performed with APF and application of L-PRF on the donor area. Patients in the control group, on the other hand, were treated with APF alone, leaving the donor area to heal by secondary intention.


Eligibility criteria: Inclusion Criteria:

* to have at least one implant in the maxilla with a quantity of vestibular keratinized gingiva \< 2 mm
* to be in good systemic health
* to have a good oral hygiene (FMPS and FMBS \< 20%)

Exclusion Criteria:

* systemic diseases: coagulation disorders; medications affecting periodontal status in the previous 6 months; pregnancy or lactation;
* smoking habits;
* peri-implant surgery on the experimental sites.

Primary outcomes:
measure: Complete re-epithelialization of the wound of donor area (CWE)
timeFrame: 4 weeks
Secondary outcomes:
measure: Post-Operative Discomfort (D)
timeFrame: 4 weeks
measure: Changes in Feedind Habits (CFH)
timeFrame: 4 weeks
measure: Consumption of Analgesics (AU)
timeFrame: 4 weeks
measure: Alteration of Sensivity (AS)
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Chieti
country: Italy
facility: G. D'Annunzio University
Study officials:
References:
Clinical trial NCT03542357: The Effect of Sumatriptan and Placebo on CGRP Induced Headache
Official title: The Effect of Sumatriptan and Placebo on CGRP Induced Headache
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine
Lead sponsor: Danish Headache Center
Sponsor class: OTHER
First posted: 2018-05-31
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To develop a pragmatic migraine model the investigators will induce headache in healthy volunteers and in patients with migraine without aura with aCalcitonine Gene Related Peptide (CGRP). If the headache responds to sumatriptan, the model can be used to test new drug candidates.

Detailed description: There remains a great need for more effective anti-migraine drugs with fewer side effects. Human experimental models are valuable in early phase development of new anti-migraine drugs but useful models have not yet been developed. The investigators' group has shown that Calcitonine Gene Related Peptide (CGRP) induce headache/migraine in both healthy volunteers and in patients with migraine without aura (MO). To validate this model, the headache must respond to specific migraine treatment with sumatriptan.

Hypothesis: CGRP induces a migraine-like headache in both healthy subjects and in MO-patients and induced headache responds to a specific anti migraine drug; sumatriptan.

Aim: Developing a pragmatic and valid model for the testing of new anti-migraine drugs.

Eligibility criteria: Inclusion criteria:

Healthy:

Healthy subjects of both sexes Age 18-60 years Weight 45-95 kg. Females were requested to use effective contraception.

Migraine patients:

Migraine patients who meet IHS criteria for migraine with or without aura of both sexes 18-60 years 45-95 kg.

Exclusion Criteria:

Healthy:

Any type of headache (except episodic tension-type headache \< 1 day per week) Serious somatic or psychiatric disease Pregnancy Intake of daily medication (except oral contraceptives).

Migraine patients:

Any other type of headache then migraine without aura (except episodic tension-type headache \< 1 day per week) Serious somatic or psychiatric disease Pregnancy Intake of daily medication (except oral contraceptives) Triptan non-responders

Primary outcomes:
measure: AUC after infusion
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Rigshospitalet Glostrup
Study officials:
References:
Clinical trial NCT02367157: Effectiveness of Kinesio Tape in Morning Stiffness and Functional Capacity in Patients With Rheumatoid Arthritis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wrist Morning Stiffness
Lead sponsor: CEU San Pablo University
Sponsor class: OTHER
First posted: 2015-02-20
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine how the applications of Kinesio Tape affect the morning stiffness in patients with rheumatoid arthritis.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Rheumatoid Arthritis according to the criteria of the American Rheumatism Association with a minimum of 6 months evolution from diagnosis.
* These subjects must have morning stiffness daily in the wrist joint of a member or bilateral at least a month.

Exclusion Criteria:

* Subjects in postoperative affecting the mobility of joints to study phase.
* Subjects with sensory deficits or other inflammatory arthropathies.
* Subjects who are or come in a state of emergence of the hand or wrist joints during the investigation.
* Subjects who change their usual treatment (medication or other therapies) two months before the study or during the study.
* We exclude subjects who present some kind of allergy to Kinesio-Tape in which case it will be removed immediately.

Primary outcomes:
measure: Change in the Wrist Morning Stiffness
timeFrame: participants will be followed for the duration in minutes of the morning stiffness, an expected average of 45 minutes]
Secondary outcomes:
Other outcomes:
Locations:
city: Boadilla del Monte
country: Spain
facility: San Pablo CEU University
state: Madrid
Study officials:
References:
Clinical trial NCT06579157: Pressure-Sensing Mattresses and Mechanical Ventilation Weaning in Neonatal
Official title: The Association Between Pressure-Sensing Mattresses and Mechanical Ventilation Weaning in Neonatal
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bronchopulmonary Dysplasia
Keywords: newborn
ballistocardiograph
pressure sensor
unobtrusive sensing
Lead sponsor: Fu Jen Catholic University
Sponsor class: OTHER
First posted: 2024-08-30
Enrollment: 60
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: infant of Affiliated University Hospital

Brief summary: This study aims to explore the correlation between using ballistocardiography for monitoring respiration and heart rate in neonates under invasive and non-invasive respiratory support.

Detailed description: Background： Traditional physiological measurement methods often require subjects to remain immobile or have various devices attached to their bodies, causing discomfort, especially unsuitable for neonatal care. However, with the development of electronic technologies, these methods have improved. ballistocardiography (BCG) presents a possible solution for monitoring neonates' physiological signals. BCG is a non-invasive and non-contact instrument that measures the body's reactive motion pressure changes caused by cardiac contraction. These sensors do not require direct attachment, allowing for long-term physiological signal measurement without disturbing the subject.

Methods： The study will be conducted in the neonatal intensive care unit on the seventh floor of Fu Jen Catholic University Hospital, with an expected enrollment of 60 participants. The subjects will be grouped and stratified based on weight and the use of invasive respiratory support. During the hospitalization, daily output of ventilator data and physiological monitor data will be collected and analyzed for correlation.

Effect： This trial is expected to confirm the application of BCG in the neonatal population, demonstrate its correlation with current conventional physiological monitors, and assess its applicability in low-weight preterm infants. Additionally, the study will investigate whether continuous BCG monitoring during hospitalization can predict the possibility of bronchopulmonary dysplasia.

Eligibility criteria: Inclusion Criteria:

* Using invasive ventilation support with flow sensors or non-invasive ventilation support
* The legal representative signs the informed consent form

Exclusion Criteria:

* Refusal to participate in the study

Primary outcomes:
measure: ballistocardiography waveform
timeFrame: through study completion, an average of 2 weeks
Secondary outcomes:
measure: tidal volume
timeFrame: through study completion, an average of 2 weeks
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Fu Jen Catholic University Hospital, Fu Jen Catholic University
Study officials:
affiliation: Fu Jen Catholic University Hospital
name: Ke-Yun Chao, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02417857: Comparison of Single İncision Laparoscopic Cholecystectomy Versus Laparoscopic Cholecystectomy
Official title: Quality-of-life, Body Image and Cosmesis After Single Incision Laparoscopic Cholecystectomy (SILC) Versus Conventional Laparoscopic Cholecystectomy (CLC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laparoscopic Surgical Procedures
Keywords: Single İncision Laparoscopic Surgery
Conventional Laparoscopic Surgery
Lead sponsor: Ankara Mevki Military Hospital
Sponsor class: OTHER
First posted: 2015-04-16
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare outcomes of quality-of-life measures and evaluate the body image and cosmesis between Single Incision Laparoscopic Cholecystectomy (SILC) and Conventional Laparoscopic Cholecystectomy (CLC).Twenty eight patients underwent SILC and 30 underwent LC.Fifty-eight patients were included the study and divided into two groups. The results of the questionnaires were statistically compared.

Detailed description: Recently, single incision laparoscopic cholecystectomy (SILC) is one of the minimally invasive technique, developed to reduce the need of multiple ports and has become popular among the surgeons. This study was conducted with fifty eight patients between January 2011 and March 2013 in Turkey. Fifty-eight patients were included the study and divided into two groups. Quality-of-life measures was evaluated by the EuroQol EQ-5D questionnaire.Cosmesis and body image were evaluated with the Body Image Questionnaire. All statistical analyses were performed by IBM Statistics 21.0 and MS-Excel 2007. A value of p\<0.05 was accepted as statistically significant.

Eligibility criteria: Inclusion Criteria:

* The patients who were scheduled for elective cholecystectomy were included in the study

Exclusion Criteria:

* pregnancy
* acute cholecystitis
* ASA 3-4 (American Society of Anesthesiologists)
* history of bile duct stone migration
* biller pancreatitis
* upper laparatomy
* any ventral hernia repair
* chronic systemic disease or
* with allergic attitude to any agent

Primary outcomes:
measure: Quality of life measure
timeFrame: We had performed the questionnaire at postoperative 6 th month
Secondary outcomes:
measure: Body Image Questionnaire measure
timeFrame: We had performed the questionnaire at postoperative 6 th month
Other outcomes:
Locations:
Study officials:
affiliation: VAN MILITARY HOSPITAL, GENERAL SURGERY DEPARTMENT, VAN, TURKEY
name: Huseyin SINAN, Prof. M.D.
role: STUDY_DIRECTOR
References:
citation: Abd Ellatif ME, Askar WA, Abbas AE, Noaman N, Negm A, El-Morsy G, El Nakeeb A, Magdy A, Amin M. Quality-of-life measures after single-access versus conventional laparoscopic cholecystectomy: a prospective randomized study. Surg Endosc. 2013 Jun;27(6):1896-906. doi: 10.1007/s00464-012-2625-5. Epub 2012 Dec 27.
Clinical trial NCT00002157: Compassionate Use Study of Two Dose Levels of Thalidomide in Adults With HIV Wasting Syndrome
Official title: Compassionate Use Study of Two Dose Levels of Thalidomide in Adults With HIV Wasting Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
HIV Wasting Syndrome
Keywords: Acquired Immunodeficiency Syndrome
Cachexia
Thalidomide
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To allow patients with HIV-associated wasting to receive thalidomide treatment at 1 of 2 doses. To gain safety and efficacy data from a broader base of patients with HIV-associated wasting in order to support Celgene's pivotal placebo-controlled study.

Detailed description: Patients are randomized to receive thalidomide at 1 of 2 doses for 12 weeks initially, with response assessed at weeks 2, 4, 8, and 12. Patients failing the low dose will be eligible to increase the dose to the higher dose. Treatment may continue indefinitely. After 12 weeks, patients continuing treatment are evaluated every 2 months for up to 6 additional months, then every 6 months thereafter.

Eligibility criteria: Inclusion Criteria

Concurrent Medication:

Allowed:

* Antiretroviral therapy.
* Prophylaxis or treatment for opportunistic infection.

Patients must have:

HIV-associated wasting.

Prior Medication:

Allowed:

* Prior enrollment on Celgene's placebo-controlled thalidomide study, provided patient meets specified criteria for not continuing on that study.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Warren
country: United States
facility: Celgene Corp
state: New Jersey
Study officials:
References:
Clinical trial NCT05623657: Comparison of the Efficiency of Game-Based Exercise Program and Trunk Stabilization Exercise Training in Adolescent Playing Archery
Official title: Game-Based Exercise Program and Trunk Stabilization Exercise Training in Adolescent Playing Archery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Athlete; Itch
Keywords: Archery
trunk
balance
exergame
core stability
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2022-11-21
Enrollment: 50
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of our study is to investigate the effects of a game-based exercise (Exergame) program and trunk stabilization exercise training on shooting performance, reaction time, trunk muscle endurance and balance in adolescents playing archery. While the importance of the effect of trunk stabilization on shooting performance is mentioned in individuals practicing archery, it is emphasized that trunk stabilization training increases sportive performance and protects against injuries in individuals interested in sports for the upper extremity. However, no study is found that directly compared game-based exercise programs and trunk stabilization exercise training in adolescents who play archery. Therefore, two different training programs will be given to the adolescents playing archery at the Archers Foundation Sports Club in Istanbul, and Shooting performance, reaction time, trunk muscle endurance, and balance levels will be evaluated before and after the training.


Eligibility criteria: Inclusion Criteria:

* Archers who have been practicing archery for at least 1 year
* Roller or Olympic archers

Exclusion Criteria:

* Archers with a history of musculoskeletal injuries causing physical limitation in the last 6 months.
* Archers who did not volunteer to participate in the study.
* Archers with any visual and hearing disabilities.

Primary outcomes:
measure: Core Endurance Tests
timeFrame: Change from baseline to 8 weeks
measure: Star Excursion Balance Test (SEBT) :
timeFrame: Change from baseline to 8 weeks
measure: Reaction Time Evaluation:
timeFrame: Change from baseline to 8 weeks
Secondary outcomes:
measure: Shooting Performance Evaluation:
timeFrame: Change from baseline to 8 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpasa
Study officials:
References:
Clinical trial NCT05264857: Decision Aid and Thyroid Nodules Management
Official title: Decision Aid for Management of Thyroid Nodules and Early Thyroid Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Thyroid Nodule
Lead sponsor: Stony Brook University
Sponsor class: OTHER
First posted: 2022-03-03
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Patients with small favorable malignant or indeterminate thyroid nodules will receive information about management of thyroid nodules. Participants will be asked to complete brief surveys at the time of enrollment, shortly after the consultation appointment with the surgeon, and a few months after either the consultation or the surgery, to assess their satisfaction with their decision and decision making process. All participants will receive routine care and counseling by their endocrinologist and surgeon.


Eligibility criteria: Inclusion Criteria:

* Histology showing indeterminate or malignant thyroid pathology (Bethesda III-VI)
* Thyroid nodule size less or equal to 2cm

Exclusion Criteria:

* History of thyroid surgery
* History of thyroid cancer

Primary outcomes:
measure: Rate of congruence between informed values and treatment choice
timeFrame: 6 months from surgery or surgical consultation date
Secondary outcomes:
Other outcomes:
Locations:
city: Stony Brook
country: United States
facility: Stony Brook University Cancer Center
state: New York
Study officials:
affiliation: Lukasz.Czerwonka@stonybrookmedicine.edu
name: Lukasz Czerwonka, MD
role: PRINCIPAL_INVESTIGATOR
References: