louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00771940: Peripheral Metabolic Effects of Ghrelin
Official title: Peripheral Metabolic Effects of Intra Arterial Ghrelin Infusion in Healthy Controls
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Controls
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2008-10-15
Enrollment: 8
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this study is to investigate putative peripheral effects of ghrelin on glucose and lipid metabolism in healthy men. Eight subjects will be enrolled. The hypothesis is that ghrelin infusion causes insulin resistance and lipolysis.


Eligibility criteria: Inclusion Criteria:

1. BMI \< 27 kg/m2
2. Written informed consent
3. Non-smoker

Exclusion Criteria:

1. Any disease including epilepsy
2. Any use of medications (excl. paracetamol)
3. Present or previous malignancy
4. Alcohol dependency
5. Allergy to any trial medication

Primary outcomes:
measure: Plasma levels of glucose
timeFrame: During study day
Secondary outcomes:
measure: Insulin signaling
timeFrame: Study day
measure: Serum levels of fatty acids
timeFrame: Study day
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
Study officials:
affiliation: Medical Department M, Aarhus University Horpital, Denmark
name: Jens Otto L. Jorgensen, MD
role: STUDY_DIRECTOR
affiliation: Medical Department M, Aarhus University Hospital, Denmark
name: Esben T Vestergaard, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02758340: Failure of Vaginal Delivery After Induction
Official title: Comparison of Maternal Outcome Between Patients Undergoing Induction of Labor With Oral Misoprostol Alone and Oral Misoprostol and Foley's Catheter Both at a Tertiary Care Hospital
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Labor Pain
Keywords: induction of labor
misoprostol
foley's balloon catheter
Lead sponsor: Karachi Medical and Dental College
Sponsor class: OTHER
First posted: 2016-05-02
Enrollment: 335
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The study will compare the number of women who deliver vaginally after artificial initiation of labor pains(i.e. induction of labor) by two methods. Half of the women would receive tablet misoprostol vaginally and the other half would receive tablet misoprostol and foley's balloon catheter both.

Detailed description: Artificial initiation of labor pains has become a common occurrence. A variety of methods are employed to initiate labor pains. Labor pains are more successful in culminating into vaginal delivery if the neck of womb that is the cervix is soft (ripe). This is usually achieved by ripening agents. They include drugs and devices that help soften the cervix. Misoprostol and foley's balloon catheter both are used to soften the cervix so that vaginal delivery is possible. Both work on different aspects of the softening of cervix.

Misoprostol acts on shortening the cervix and making it more pliable Foley's balloon helps to open up the cervix that is it aids in dilating the cervical canal.

Eligibility criteria: Inclusion Criteria:

* Gestational age \> 37 weeks assessed by Last Menstrual Period and dating scan.
* Women with singleton pregnancy assessed by ultrasound.
* Fetus in vertex presentation assessed by ultrasound.
* Age 20-40 years.
* Bishop score \<4.

Exclusion Criteria:

* Non-consenting.
* Gestational age \< 37 weeks.
* Patients with history of placenta previa.
* Patients with history of placental abruption.
* Ruptured membranes.
* Patients with history of vaginal infection.
* Patients with history of congenital anomalies in previous deliveries.
* Patients with history of stroke, renal impairment and chronic obstructive pulmonary disease, chronic liver disease and congestive cardiac failure

Primary outcomes:
measure: failure of vaginal delivery i.e.percentage of women in both groups who would fail to deliver vaginally after 24 hours of induction.
timeFrame: six months
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Abbasi shaheed hospital
state: Sindh
Study officials:
affiliation: Karachi Medical and Dental College
name: samia husain, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06779240: Distinguishing Non-Specific Low Back Pain from Scoliosis-Related Pain Via Quality of Life Questionnaires
Official title: Non-specific Low Back Pain and Low Back Pain Secondary to Scoliosis: is It Possible to Differentiate Them Through Quality of Life Questionnaires?
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Idiopathic Scoliosis
Degenerative Scoliosis
Lead sponsor: Istituto Scientifico Italiano Colonna Vertebrale
Sponsor class: OTHER
First posted: 2025-01-16
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with LBP or scoliosis accessing a tertiary referral outpatient clinic specialized in the conservative treatment of spinal deformities

Brief summary: Vertebral deformities, such as scoliosis, can have a significant impact on the physical and psychological health of patients. Over time, specific tools have been developed to investigate the extent of this impact; the SRS-22 (Scoliosis Research Society) questionnaire is the most commonly used instrument for assessing quality of life (QoL) in patients with idiopathic scoliosis. The Oswestry Disability Index (ODI), on the other hand, was developed to evaluate the quality of life in adult patients with chronic non-specific low back pain.

The clinical protocols at our institute involve the regular and continuous evaluation of the quality of life in patients undergoing treatment and monitoring for scoliosis and other vertebral deformities. To this end, the SRS-22 questionnaire and the ODI questionnaire are employed, along with other measures such as the COMI (Core Outcome Measure Index) and ISYQoL (Italian Spine Youth Quality of Life).

The aim of this study is to compare the properties of the ODI with those of the SRS-22 questionnaire in adults, by analyzing differences between individuals with non-specific low back pain and those with scoliosis. The secondary objective involves a sub-analysis based on the severity of scoliosis, dividing curves into major (30° Cobb or higher) and minor (below 30° Cobb). Finally, if sufficient data are available, the study will also evaluate other commonly used questionnaires (COMI and ISYQoL).


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Diagnosis of idiopathic or degenerative scoliosis with a curve \>10° Cobb and
* low back pain
* Diagnosis of non-specific low back pain

Exclusion Criteria:

* Previous spinal surgery
* Significant past illnesses, surgeries, or trauma
* Secondary scoliosis
* Other deformities such as spondylolisthesis and spinal canal stenosis
* Incomplete ODI and SRS-22 data

Primary outcomes:
measure: Questionnaires comparison
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: ISICO
Study officials:
References:
Clinical trial NCT05818540: Sleep Apnea Study in Adults Using DreamPort-Eclipse and a Traditional Nasal Mask
Official title: Randomized Controlled Trial to Compare Effectiveness of DreamPort-Eclipse to a Traditional Nasal Mask
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Lead sponsor: Bleep, LLC
Sponsor class: INDUSTRY
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2023-04-19
Enrollment: 173
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The Randomized Controlled Trial of Bleep DreamPort-Eclipse Study is a two-arm, randomized, prospective, non-blinded study to assess the effectiveness of the novel CPAP human interface design to improve leak, AHI, and pressure compared to a traditional nasal mask.


Eligibility criteria: Inclusion Criteria:

• Male or female ≥18 years old who are impacted by obstructive sleep apnea and currently are familiar with a CPAP device

Exclusion Criteria:

* Any medical or behavioral conditions that would compromise subject safety
* Under the age of 18 years old

Primary outcomes:
measure: Apnea-Hypopnea Index (AHI)
timeFrame: 60 days
measure: Leak
timeFrame: 60 days
measure: CPAP Device Pressure
timeFrame: 60 days
Secondary outcomes:
measure: Participant satisfaction with the mask choice:
timeFrame: 60 days
measure: Mask Acceptance
timeFrame: 60 days
Other outcomes:
Locations:
city: Murfreesboro
country: United States
facility: Sleep Centers of Middle Tennessee
state: Tennessee
Study officials:
affiliation: Bleep, LLC
name: Stuart Heatherington
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04616040: A Real-world Study Evaluating the Usage of Camrelizumab in Chinese Patients With Advanced Esophageal Cancer
Official title: A Non-interventional Registration Study Evaluating the Usage of Camrelizumab in the Treatment of Unresectable Locally Advanced/Recurrent or Metastatic Chinese Patients With Esophageal Cancer
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Esophageal Cancer
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2020-11-04
Enrollment: 1030
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: unresectable locally advanced/recurrent or metastatic esophageal cancer

Brief summary: The trial is a multi-center, open, observational registration study, which aims to evaluate the safety and efficacy of Camrelizumab (anti-PD-1 antibody) in the treatment of Chinese patients with advanced esophageal cancer in the real world.


Eligibility criteria: Inclusion Criteria:

1. Sign informed consent and voluntarily participate in this study.
2. Unresectable locally advanced/recurring or distant metastatic esophageal cancer patients confirmed by histology or cytology (AJCC 8th edition);

   * Unresectable locally advanced patients who are unable or unable to receive radical treatment (including radical radio chemotherapy or radical radiotherapy, etc.) may be considered for inclusion;
   * Patients who progress or relapse after neoadjuvant or adjuvant therapy may also be considered for inclusion;
3. Age ≥ 18 years old;
4. The investigator determines that the patient can receive Camrelizumab as a single agent or combination therapy.

Exclusion Criteria:

1. Evidence suggests that the patient is pregnant or breastfeeding;
2. Other drug blinded clinical trials are currently underway;
3. Other situations that are not suitable for inclusion in this study.

Primary outcomes:
measure: Adverse events of Camrelizumab
timeFrame: an expected average of 24 months
Secondary outcomes:
measure: Adverse events of Camrelizumab
timeFrame: an expected average of 24 months
measure: Overall Survival
timeFrame: an expected average of 24 months
measure: Progression-free Survival (PFS)
timeFrame: an expected average of 24 months
measure: Objective Response Rate (ORR)
timeFrame: an expected average of 24 months
Other outcomes:
measure: Correlations between biomarkers and clinical activity
timeFrame: an expected average of 24 months
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT04185740: Medication Responsiveness in Parkinson's Disease
Official title: The Stability in Medication Responsiveness During Research Experiments in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Parkinson Disease
Medication Compliance
Tapping Task
Smartphone
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2019-12-04
Enrollment: 33
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Up till now, dopaminergic replacement is considered as the gold standard for the symptomatic treatment of motor symptoms in Parkinson's disease (PD). However, the intake, especially higher doses when taken for a longer duration, are associated with several side effects including response fluctuations. These fluctuations in medication response are often characterized by a wearing-OFF period, also defined as the recurrence of PD symptoms before a patient should take the next dose of medication. The duration of test sessions during research experiments (e.g. in the field of rehabilitation) can interfere with the period of the optimal therapeutic effect of dopaminergic medication, influencing outcomes of a study. Therefore, the objective of this project is to get more insight in the measurability of ON-OFF fluctuations by testing the applicability of a short and simple timed tapping task (TTT) on a smartphone in rehabilitation research studies. The assessment can be useful for future clinical studies in PD where a precise estimation of medication is indispensable for accurate research outcomes.


Eligibility criteria: Inclusion Criteria:

* A diagnosis of PD, based on the UK Brain Bank Diagnostic Criteria
* Hoehn \& Yahr stage I-III
* Mini Mental State Examination (MMSE) scores \>24
* Right-handedness
* No other known disease or disorder that will interfere with the experiments

Primary outcomes:
measure: Tap frequency
timeFrame: 7 days
measure: Mean hand movement time between taps
timeFrame: 7 days
measure: Actual distance between taps
timeFrame: 7 days
measure: Visual analogue scale (VAS)
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Department of Rehabilitation Sciences
Study officials:
affiliation: KU Leuven
name: Alice Nieuwboer
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stamate, C., et al., The cloudUPDRS app: A medical device for the clinical assessment of Parkinson's Disease. Pervasive and Mobile Computing, 2018. 43: p. 146-166.
Clinical trial NCT05461040: Optic Capture Without Anterior Vitrectomy in Pediatric Cataract Surgery
Official title: Optic Capture Without Anterior Vitrectomy in Pediatric Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract, Juvenile
Keywords: cataract surgery; intraocular lens; optic capture; pediatric cataract; posterior capsulotomy
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2022-07-15
Enrollment: 37
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Purpose: To compare two pediatric cataract surgery procedures: intraocular lens (IOL) optic capture without anterior vitrectomy (AV) and in-the-bag IOL implantation with AV.

Setting: Ege University Medical School Hospital, Izmir, Turkey. Design: Prospective randomized control clinical trial. Methods: Patients were randomly assigned to two groups: optic capture without AV (Group 1) or in-the-bag implantation with AV (Group 2). The following variables were compared: visual acuity, intraocular pressure, refractive errors, IOL tilt and decentration, lenticular astigmatism, anterior-posterior synechia, inflammatory cell deposits on IOL and post-operative complications.


Eligibility criteria: Inclusion Criteria:

* Children with congenital or developmental cataracts who had cataract surgery and primary IOL implantation at a tertiary care referral institute were included.

Exclusion Criteria:

* Traumatic or uveitic cataract, corneal opacity, iris coloboma, microphthalmia, microcornea, persistent fetal vascularization, congenital glaucoma, and retinopathy of prematurity were all considered exclusion criteria.

Primary outcomes:
measure: The prevalence of visual axis opacification
timeFrame: through study completion, an average of 2 years
measure: The prevalence of inflammatory deposits on Intraocular lens surface
timeFrame: through study completion, an average of 2 years
measure: The prevalence of anterior-posterior synechia
timeFrame: through study completion, an average of 2 years
measure: Measurements of Intraocular lens tilt and decentration.
timeFrame: at the postoperative one-year
measure: Prediction error
timeFrame: at the post-operative one-month
Secondary outcomes:
measure: Intraocular pressure
timeFrame: at the postoperative one year
measure: Lenticular astigmatism
timeFrame: One-year postoperatively
measure: Posterior segment complications
timeFrame: through study completion, an average of 2 years
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Ege University
Study officials:
affiliation: Ege University, Department of Ophthalmology
name: Ali Devebacak, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04032340: Companion Dog & Loneliness in Elderly Persons
Official title: Companion Dog Impact on Loneliness and Social Link in Elderly Persons (≥ 75 Years Old) Living at Home : a Comparative Transversal Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Elderly
Companion Dog
Home Based
Loneliness
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Fondation MUTAC
First posted: 2019-07-25
Enrollment: 200
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Elderly (≥75 years old) living at home, with or without a companion dog, visiting their doctor

Brief summary: Elderly may have problems to create personal connections or to have physical activities in their day- to - day life; loneliness and social isolation may increase fragility in this population. Companion dog presence favours social relations, affective feelings and physical exercises. On the other hand dog presence raises risk of falling and has a cost for its owner. This project seeks to assess positive impacts of companion dog presence in elderly living at home. This transdisciplinar study (general practionners, veterinarians, dog instructors, nurses, researchers) evaluates loneliness and social isolation between elderly with or without a companion dog at home.

Objective:To Evaluate the link between companion dog presence and loneliness in elderly persons living at home Method: An Observational, multicentric, transversal, national, comparative study (elderly with companion dog vs elderly without a dog). 200 subjects needed


Eligibility criteria: Inclusion Criteria:

* person aged ≥ 75years old
* living at home

Exclusion Criteria:

* bedridden person
* person accompanied by any animal, other than a dog
* EPHAD based (establishments providing care for the dependent elderly)
* comprehension or reading difficulties in french affecting study participation and scales assessment
* cognitive, mental ou psychic disorders
* person under legal protection

Primary outcomes:
measure: assessment of loneliness using Jong Gierveld scale (11items).
timeFrame: 5 to 10 days after inclusion visit
Secondary outcomes:
measure: social isolation
timeFrame: 5 to 10 days after inclusion visit
Other outcomes:
Locations:
Study officials:
affiliation: APHP CHU HENRI MONDOR
name: FLORENCE CANOUI-POITRINE, MD-PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02745340: Substitution of Acetate by Citrate in the Bicarbonate Based Hemodialysis
Official title: Effect of an Acetate-free Dialysis (Citrate Based) on Parameters of Central Hemodynamics, Dialysis Adequacy, Quality of Life and Immunological Parameters in Chronic Hemodialysis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: End Stage Renal Disease (ESRD)
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
Collaborators: name: Gambro Renal Products, Inc.
First posted: 2016-04-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: Acetate is the primary acidifying solution used in bicarbonate-based hemodialysis worldwide. It has been published in small trials or case series that the addition of acetate is associated with a rise in nitric oxide production of vascular smooth muscle cells, endothelial cells and myocardial cells as a sign of vascular dysfunction. Furthermore clinical side effects of dialysis e.g. nausea, malnutrition, intradialytic blood pressure drops, induction of proinflammatory cytokines and activation of complement and leukocytes have been described with acetate.

Citrate on the other hand was associated with: Acid-base disorders (metabolic alkalosis), Disturbances of the calcium homeostasis (Hypocalcemia), but also anti-inflammatory effects. Both dialysate additives (citrate and acetate) are commercially available and are used world wide in dialysis centers.

The investigators hypothesize that substitution of acetate by citrate reduces the cardiovascular risk (measured by a change in the surrogate parameter of pulse wave velocity and Augmentation index) and might improves quality of life in the participants. Furthermore the investigators speculate that citrate in the dialysis solution could reduce systemic inflammation in the participants of the study.


Eligibility criteria: Inclusion Criteria:

* time since initiation of dialysis \> 3 months
* age \> 18 years
* dialysis 3x/week for \> 4 hrs

Exclusion Criteria:

* ongoing infection
* pregnancy
* lack of written and informed consent

Primary outcomes:
measure: Change in Augmentation Index (AIx)
timeFrame: 6 months (cross over after 3 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Nierenzentrum24 NEUPERLACH
state: Bavaria
city: Munich
country: Germany
facility: Nierenzentrum Bogenhausen
state: Bavaria
Study officials:
affiliation: attending, board certified nephrologist
name: Christoph Schmaderer, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Molina Nunez M, de Alarcon R, Roca S, Alvarez G, Ros MS, Jimeno C, Bucalo L, Villegas I, Garcia MA. Citrate versus acetate-based dialysate in on-line haemodiafiltration. A prospective cross-over study. Blood Purif. 2015;39(1-3):181-187. doi: 10.1159/000371569.