louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01515371: Dose Finding Study for a Botulinum Toxin Type A Injection to Treat Habitual Snoring
Official title: Prospective, Randomized, Double-blind, Placebo-controlled, Parallel-group, 3-stage Dose-finding Study to Identify a Safe and Effective Dose of NT 201 for Unilateral Injection Into the Soft Palate for Treatment of Habitual Snoring
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Habitual Snoring
Lead sponsor: Merz Pharmaceuticals GmbH
Sponsor class: INDUSTRY
First posted: 2012-01-24
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
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 identify out of up to three doses a safe and effective dose of Botulinum toxin type A for an injection into one side of the soft palate to treat snoring.


Eligibility criteria: Inclusion Criteria:

* Female or male subjects aged 18-70
* Subjects suffering from snoring for at least 3 months prior to the study start and seeking for help to treat snoring
* Subjects with a peak Snoring Index \[SI\] ≥ 15/ hour of sleep \[h\] at baseline visit
* Subjects with a bed partner for at least three months prior to study start.
* Subjects who understand the nature of the study and provide written Informed Consent at screening visit.
* Subjects who understand the study procedures as well as possess the ability and willingness to abide by all procedures during the course of the study

Exclusion Criteria:

* Obese subjects (Body Mass Index ≥ 30)
* Subjects with severe obstructive sleep apnea syndrome
* Subjects with Apnea-Hypopnea Index ≥ 10 /hour of sleep and/ or Respiratory Disturbance Index ≥ 25 / hour of sleep at the baseline visit
* Subjects who have undergone any Botulinum neurotoxin treatment in the history
* Subjects with generalized disorders of muscle activity (e.g. myasthenia gravis, Lambert-Eaton syndrome)
* Acute infections of the pharynx

Primary outcomes:
measure: Relative change from baseline in Snoring Index at week 4
timeFrame: Baseline to week 4
Secondary outcomes:
measure: Absolute change from baseline in Snoring Index at week 4
timeFrame: Baseline to week 4
measure: Bed partner satisfaction
timeFrame: Week 4
measure: Change from baseline in loudness at week 4.
timeFrame: Baseline to week 4
Other outcomes:
Locations:
city: Regensburg
country: Germany
facility: Merz Investigational Site #049294
Study officials:
affiliation: Merz Pharmaceuticals GmbH
name: Medical Expert
role: STUDY_CHAIR
References:
Clinical trial NCT06714071: Relation of C-reactive Protein/ Albumin Ratio and Coagulation Profile in Acute Myeloid Leukemia Patients
Official title: Relation of C-reactive Protein/ Albumin Ratio and Coagulation Profile in Acute Myeloid Leukemia Patients
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: AML
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-12-03
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all cases newly diagnosed with acute myeloid leukemia

Brief summary: The investigators will investigate the relation between CAR and coagulation profile in newly diagnosed AMl patients

Detailed description: Acute myeloid leukaemia (AML) is an aggressive haematological malignancy with a high degree of heterogeneity. It has long been recognized that systemic inflammation is associated with tumorigenesis it revealed that elevated C-reactive protein levels were associated with worse survival outcomes in patients with various types of cancer, including hematologic malignancies. Serum albumin is a measure of an individual's nutritional status. Systemic inflammation can reduce serum albumin concentrations by increasing capillary permeability . The ratio of CRP to albumin (CAR) is a useful score based on inflammation and nutrition, reflecting not only systemic inflammation status but also nutritional status. The Glasgow prognostic score (GPS) and modified GPS (mGPS), determined by the serum CRP and albumin levels, have been proposed as prognostic indicators for AML patients. However, the clinical correlations of CAR and its prognostic value in AML patients have not yet been clarified. Abnormalities of hemostasis can occur in leukemia in the form of disseminated intravascular coagulation(DIC), coagulation protein defect and primary fibrinolysis . Clinically, Types of acute myeloid leukemia like acute promyelocyticleukemia has a high frequency of haemorrhage due to disseminated intravascular coagulation (DIC), which contributes to the high mortality rate of this disease . Therefore, the investigators will investigate CAR its relation with inflammatory response and coagulation profile levels in newly diagnosed acute myeloid leukemia and after 3 month follow up to compare their level and the relation between .

Eligibility criteria: Inclusion Criteria:

- all cases newly diagnosed with acute myeloid leukemiain assuit university hospital

Exclusion Criteria:

1. cases with chronic myeloid leukemia
2. cases with acute lymphoblasticleukemia

Primary outcomes:
measure: Correlation between C- reactive protein and coagulation profile in AML patients
timeFrame: Study complete an average 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University
Study officials:
affiliation: Director
name: sohir kamel, prof
role: STUDY_DIRECTOR
References:
Clinical trial NCT05248971: Implementation of Truma-Focused Cognitive Behavioral Therapy (TF-CBT) in Norway
Official title: Implementation of Trauma-focused Cognitive Behavioral Therapy (TF-CBT) in Norwegian Child and Adolescent Mental Health Clinics
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: PTSD
Keywords: PTSD
Trauma treatment
Implementation
Lead sponsor: Norwegian Center for Violence and Traumatic Stress Studies
Sponsor class: OTHER
First posted: 2022-02-21
Enrollment: 26500
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children and adolescents aged 6-18 referred to Norwegian child and adolescent mental health clinics.

Brief summary: Trauma-focused cognitive behavioral therapy (TF-CBT) is an evidence-based treatment method for children and adolescents who have been exposed to traumatic experiences and who are experiencing posttraumatic stress symptoms. TF-CBT has been implemented in Norwegian child and adolescent mental health clinics since 2012. The Ministry of Health is funding the implementation project, and the Norwegian Center for Violence and Traumatic Stress Studies (NKVTS) is responsible for the implementation, including training of therapists, quality monitoring, and research.

Detailed description: All participating child and adolescent mental health clinics received training by TF-CBT senior trainers at NKVTS in screening for trauma exposure and posttraumatic stress. A sub-sample of the therapists received training in TF-CBT. Data are collected on treatment outcomes for quality assurance.

Eligibility criteria: Inclusion Criteria:

* 6-18 years
* Referred to Norwegian child and adolescent mental health clinics

Exclusion Criteria:

* Below 6 years and above 18 years

Primary outcomes:
measure: Child and Adolescent Trauma Screen (CATS)
timeFrame: 2012-2014
measure: Child PTSD Symptom Scale (CPSS)
timeFrame: 2015-2021
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Norwegian Center for Violence and Traumatic Stress Studies
name: Ane-Marthe S Skar, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Skar AS, Braathu N, Jensen TK, Ormhaug SM. Predictors of nonresponse and drop-out among children and adolescents receiving TF-CBT: investigation of client-, therapist-, and implementation factors. BMC Health Serv Res. 2022 Sep 29;22(1):1212. doi: 10.1186/s12913-022-08497-y.
Clinical trial NCT04441671: Oral Pyrophosphate Absorption in PXE Disease
Official title: Oral Disodiumpyrophosphate (Na2H2PPi) Absorption in Pseudoxanthoma Elasticum (PXE)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Pseudoxanthoma Elasticum
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
Collaborators: name: UMC Utrecht
name: Hungarian Academy of Sciences
First posted: 2020-06-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Pyrophosphate is an endogenous, non-toxic metabolite inhibiting soft tissue calcification. The aim of our study is to find optimal dosing and safety of oral disodium-PPi (Na2H2PPi). Absorption curves (pharmacokinetics), AUC0-t, Cmax and Tmax for PPi and phosphate will be provided for healthy controls and PXE-patients both fasting and with standard meal intake.

Detailed description: Phase II oral capsulized disodium-PPi (Na2H2PPi) powder absorption study in subjects with PXE (n=8-12) will be done in the ward of Internal Medicine of Tampere University Hospital and University Medical Center Utrecht.

After a 10-hour fast at 8.00 a.m. 30 mg/kg (first day) and 50 mg/kg (second day) capsulized dose of PPi will be given with 2 dl water. At 12.00 a.m. another capsulized 30 mg/kg (first day) or 50 mg/kg (second day) single dose of PPi with a standard mixed meal (lunch) will be given with 2 dl water at the time when a subject starts eating.

Plasma and urine sampling include plasma and spot urine electrolytes, creatinine, and pyrophosphate. Plasma sampling will be done at 0, 15, 30, 60, 120 and 240 min after ingestion of PPi. Urine spot sample will be taken at 0 and 240 min after ingestion of PPi.

Physical activity is restricted. Side-effects will be recorded.

Eligibility criteria: Inclusion Criteria:

* Adults (\>18 yrs)
* clinically and genetically proven PXE
* Body mass index (BMI) 18,5-34,9 kg/m2

Exclusion Criteria:

* Special groups according to researchers' decision.
* Pregnancy
* No effective contraception in females in child-bearing age.

Primary outcomes:
measure: Concentration area under the curve 0-t of pyrophosphate
timeFrame: two days
measure: Maximal concentration of pyrophosphate
timeFrame: two days
measure: Timepoint of maximal pyrophosphate concentration
timeFrame: two days
Secondary outcomes:
measure: Concentration area under the curve 0-t of phosphate
timeFrame: two days
measure: Maximal concentration of phosphate
timeFrame: two days
measure: Timepoint of maximal phosphate concentration
timeFrame: two days
Other outcomes:
Locations:
Study officials:
affiliation: Tampere University Hospital
name: Pasi I Nevalainen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02234271: Plan A Birth Control: Randomized Controlled Trial of a Mobile Health Application for Contraception Information
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mobile Applications
Contraception
Contraception Behavior
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2014-09-09
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The primary objective of the investigators study was to design a comprehensive and medically accurate contraception counseling mobile health application and evaluate the effects of this contraception counseling application on the contraceptive methods that patients selected and their knowledge of that method.


Eligibility criteria: Inclusion Criteria:

* 18-45 years of age
* literate in English
* not at that time using a contraceptive method
* willing to switch to a new reversible contraceptive method
* currently sexually active with a male partner and
* intending to avoid pregnancy for at least one year

Exclusion Criteria:

* women not at risk for unintended pregnancy
* those who were pregnant
* seeking pregnancy within the next 12 months
* history of surgical sterilization or
* a current partner who had had a vasectomy
* using long acting reversible birth control method
* menopausal

Primary outcomes:
measure: Contraception choice
timeFrame: Participants were followed for the duration of their clinic visit which was up to one day
Secondary outcomes:
measure: Knowledge of contraception method chosen
timeFrame: Participants were followed for the duration of their clinic visit which was up to one day
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: West Medical Clinic
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Aparna Sridhar, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sridhar A, Chen A, Forbes ER, Glik D. Mobile application for information on reversible contraception: a randomized controlled trial. Am J Obstet Gynecol. 2015 Jun;212(6):774.e1-7. doi: 10.1016/j.ajog.2015.01.011. Epub 2015 Jan 9.
Clinical trial NCT06413771: Only Gonadotropin Vs. Letrozole Combined Gonadotropin Stimulation in IUI Cycles
Official title: Comparison of Two Ovarian Stimulation Strategies in Intrauterine Insemination Cycles of Couples With Unexplained Infertility; Only Gonadotropin Vs. Letrozole Combined Gonadotropin Stimulation. A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility Unexplained
Keywords: unexplained infertility
letrozole
gonadotropin
intrauterine insemination
Lead sponsor: Uludag University
Sponsor class: OTHER
First posted: 2024-05-14
Enrollment: 131
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The present randomized controlled study aims to investigate the effectiveness of a combined regimen of letrozole and gonadotropin with dose adjustments based on body mass index (BMI) compared to a conventional only gonadotropin regimen in intrauterine insemination (IUI) cycles for couples experiencing unexplained infertility. The study was conducted at a tertiary university hospital's Assisted Reproductive Technologies (ART) center from January 2023 to January 2024. Couples with unexplained infertility were enrolled based on comprehensive assessments, and randomization was performed based on national ID (odd or even). The Conventional Only Gonadotropin (COG) group received recombinant FSH based on body mass index (BMI), while the Combined Letrozole-Gonadotropin (CLG) group received letrozole followed by gonadotropin with dose adjustments based on BMI. Ovulation induction and IUI were performed according to standard protocols. Clinical outcomes, gonadotropin consumption, and pregnancy rates were compared between groups. Among 317 IUI cycles, 131 couples with unexplained infertility were randomized (CLG: 61, COG: 70). Demographic parameters were similar between groups. The CLG group had lower daily gonadotropin doses (67 ± 18 IU/D vs. 76 ± 11 IU/d, p=0.01) and total gonadotropin consumption (750 IU vs. 825 IU, p=0.01) with comparable ovulation and clinical pregnancy rates. The COG group exhibited higher multiple pregnancy rates, although not statistically significant (CLG vs. COG; 1/61 vs. 3/70, p=0.4). The study suggests that the combined letrozole and gonadotropin regimen with BMI-based dose adjustments in IUI cycles for unexplained infertility is associated with reduced gonadotropin consumption and potentially lower multiple pregnancy rates.


Eligibility criteria: Inclusion Criteria:

* Couples with unexplained infertility
* Aged between 18-35

Exclusion Criteria:

* Male factor infertility
* Diminished ovarian reserve
* Patient refusion to participate

Primary outcomes:
measure: Clinical Pregnancy Rate
timeFrame: 6 weeks
Secondary outcomes:
measure: Multiple Pregnancy Rate
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Uludag University Faculty of Medicine
state: Gorukle
Study officials:
affiliation: Uludag University
name: Gurkan Uncu, Prof.
role: STUDY_CHAIR
References:
Clinical trial NCT00377871: Hemodynamic Performance in Stentless Heart Valves
Official title: Hemodynamic Performance in Stentless Heart Valves
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Valve Diseases
Keywords: Stentless
Biological
aortic
heart
valve
prosthesis
artificial
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
name: LivaNova
name: Abbott Medical Devices
name: Raimond and Dagmar Ringgård-Bohn's Foundation
name: Carl og Ellen Hertz´ Legat
name: Direktør Kurt Bønnelycke og hustru Grete Bønnelyckes Fond
name: Jens Anker Andersen Fonden
First posted: 2006-09-19
Enrollment: 15
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hypothesis: Stentless bioprostheses will perform superior to stented bioprostheses in different hemodynamic and biomechanical parameters.

The study will investigate turbulence, flow and aortic root movement in a stentless bioprosthesis and compare it to a stented bioprosthesis.


Eligibility criteria: Inclusion Criteria:

* Over 65 years old
* Submitted for aortic valve surgery
* No coronary surgery other than LIMA to LAD

Exclusion Criteria:

* Stentless valve implantation not possible
* Contraindications for MRI scan

Primary outcomes:
measure: turbulence
timeFrame: jan 2010
measure: flow dynamics
timeFrame: jan 2010
measure: aortic root dynamics
timeFrame: jan 2010
measure: Effective orifice area
timeFrame: 2010
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus N
country: Denmark
facility: Hjerte-lunge-karkirurgisk afdeling T, Skejby Sygehus
Study officials:
affiliation: Hjerte-lunge-karkirurgisk afdeling T, Skejby Sygehus
name: Jonas A Funder, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05472571: Pilot Project of Forest Bathing for Promoting Health
Official title: FOREST HEALTH: Pilot Project of Forest Bathing for Promoting Health, Human Wellbeing, and for Complementing Sustainable Management Forest and Landscape Practices
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intellectual Disability
Lead sponsor: Clinica Universidad de Navarra, Universidad de Navarra
Sponsor class: OTHER
Collaborators: name: La Caixa Foundation
name: Fundación Caja Navarra
First posted: 2022-07-25
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: An exploratory trial using a cuasi-experimental design aimed to improve the quality of life of people with intellectual disabilities. The intervention consists of 11 consecutive sessions of forest bathing (one session per week), each one lasting about 2 hours. Each session involves an easy walk through a forest area, interspersed with non-intrusive activities of contact with the surrounding nature aimed at fostering mindfulness and the use of the five senses. Data were collected at baseline, post intervention, and 7 months of follow-up.


Eligibility criteria: Inclusion Criteria:

* Adults with intellectual disability enrolled in a specific occupational center.
* Being informed about the study and having signed the informed consent document.

Exclusion Criteria:

* Having stated their not willing to participate in the study

Primary outcomes:
measure: Systolic and diastolic blood pressure
timeFrame: 1 minute
measure: Heart coherence
timeFrame: 5 minutes
measure: Perceived quality of life and wellbeing
timeFrame: 30 minutes
Secondary outcomes:
measure: Physiological Equivalent Temperature
timeFrame: 10 minutes
measure: Thermic perception
timeFrame: 3 minutes
measure: Barriers and facilitators
timeFrame: 2 hours
Other outcomes:
Locations:
city: Pamplona
country: Spain
facility: Universidad de Navarra
state: Navarra
Study officials:
References:
citation: Hoppe P. The physiological equivalent temperature - a universal index for the biometeorological assessment of the thermal environment. Int J Biometeorol. 1999 Oct;43(2):71-5. doi: 10.1007/s004840050118.
Clinical trial NCT04435171: Comparison of Postoperative Early Period Quality of Life of Patients With Open and Robot Assisted Kidney Transplantation
Official title: Comparison of Postoperative Early Period Quality of Life of Patients With Open and Robot Assisted Kidney Transplantation: a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Quality of Life
Keywords: End Stage Renal Disease
Renal Transplantation
Quality of Life
Lead sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Sponsor class: OTHER_GOV
First posted: 2020-06-17
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who were performed open or robot assisted renal transplantation due to End Stage Renal Disease

Brief summary: The investigators aimed to investigate the quality of life in patients with end-stage renal disease who underwent open or robot-assisted renal transplantation. Also, the investigators sought to determine the parameters which can affect the quality of life in these patients

Detailed description: Patients who underwent open or robot-assisted renal transplantation at Bakirkoy Sadi Konuk Training and Research Hospital between June 2016 and December 2018 constituted the target population of this study. After application of the inclusion and exclusion criteria, the patient group was divided into two groups as per the surgical technique (i.e., open vs. robot-assisted). Demographic data, preoperative and postoperative data of all patients were collected prospectively. The quality of life of the patients was assessed preoperatively and on the postoperative 30th day

Eligibility criteria: Inclusion Criteria:

* Patients aged between 18 and 75
* Who were diagnosed with End Stage Renal Disease (i.e., estimated glomerular filtration rate loer than 20 ml/minute or symptomatic uremia or dialysis requirement)
* Received a kidney from a live donor

Exclusion Criteria:

* Patients with mental retardation, dementia, and psychotic or cognitive disorders, including delirium
* Patients who underwent deceased renal transplantation and who underwent simple bilateral nephrectomy or any other surgical procedure concurrent with Open renal transplantation
* Patients who died or had graft failure during the study period

Primary outcomes:
measure: Percentage of change for Quality of Life (measure : Short Form 36) after open and robot assisted renal transplantation
timeFrame: From just before the treatment and up to 30 days after the surgery was performed
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bakirkoy Dr Sadi Konuk Training and Research Hospital, Department of Urology
Study officials:
affiliation: Bakırkoy Dr. Sadi Konuk Training and Research Hospital
name: Mithat Ekşi
role: PRINCIPAL_INVESTIGATOR
References: