louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04864704: Immediate Decrease of Muscle Biomechanical Stiffness Following Dry Needling in Asymptomatic Participants
Official title: Immediate Decrease of Muscle Biomechanical Stiffness Following Dry Needling in Asymptomatic Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Bradley University
Sponsor class: OTHER
First posted: 2021-04-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 60 healthy participants were randomized into infraspinatus, erector spinae, or gastrocnemius groups. One session of dry needling DN was applied to the muscle in standardized location. Stiffness was assessed using a MyotonPRO at baseline, immediately post DN, and 24 hours later. The presence of a localized twitch response (LTR) during DN was used to subgroup participants.


Eligibility criteria: Inclusion Criteria:

* men and women ages 18 to 65 years
* reported good general health
* tenderness or palpable trigger point in the muscle (infraspinatus, gastrocnemius, or erector spinae)

Exclusion Criteria:

* BMI \> 30kg/m2
* surgery in the prior 12 months
* current pain in the shoulder, low back, and lower leg
* precautions to dry needling treatment (anticoagulant medications, bleeding disorders, known pregnancy)

Primary outcomes:
measure: Change in Stiffness
timeFrame: Change from baseline and immediately post intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Peoria
country: United States
facility: Bradley University
state: Illinois
Study officials:
References:
Clinical trial NCT05205304: The Role of Transdermal CO2 in MDA Level in Patient Underwent Abdominal Aortic Temporary Cross Clamp
Official title: The Role of Transdermal Carbon Dioxide in Malondialdehyde Level as Predictor of Ischemia Reperfusion Injury in Patients Underwent Abdominal Aortic Temporary Cross Clamp
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Placenta Accreta
Keywords: Abdominal Aortic Cross Clamp
Lead sponsor: Universitas Airlangga
Sponsor class: OTHER
First posted: 2022-01-25
Enrollment: 30
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects will be divided into two groups. The first group is treated with CO2 transdermal administration and the second group is the control group.
Primary purpose: TREATMENT

Brief summary: The Role of Transdermal Carbon Dioxide in Malondialdehyde Level as Predictor of Ischemia Reperfusion Injury in Patients Underwent Abdominal Aortic Temporary Cross Clamp

Detailed description: Abdominal aortic temporary cross clamping procedures in patients with placenta accreta undergoing hysterectomy have been performed at Dr. Soetomo Hospital Surabaya for a period of 4 years. In the aortic cross-clamping procedure, an ischemic condition occurs, after the cross-clamp is released the distal tissue from the occlusion which was initially in an ischemic state gets blood flow suddenly (reperfusion) causing Ischemia Reperfusion Injury. This study aims to determine the effect of transdermal administration of carbon dioxide (CO2) as a protective factor for ischemia reperfusion injury in patients undergoing Abdominal Aorta Temporary Cross Clamp. The design of this study is experimental in patients who underwent Abdominal Aorta Temporary Cross Clamp. Subjects were divided into two groups. The first group was treated with CO2 transdermal administration and the second group was the control group.

Eligibility criteria: Inclusion Criteria:

* Patients with Placenta Accreta diagnosed with placental accreta index (PAI) based on the results of ultrasound and underwent Abdominal Aorta Clamping Surgery (Control of Bleeding in Accreta)

Exclusion Criteria:

* Patients with severe comorbid disorders based on previous clinical examination: chronic kidney disease, heart disease
* Patients with septic shock and sepsis
* Patients with peripheral artery disease

Primary outcomes:
measure: Malondyaldehyde
timeFrame: Basal, 1 hour after aortic cross clamp off
Secondary outcomes:
Other outcomes:
Locations:
city: Surabaya
country: Indonesia
facility: Hari Daswin Pagehgiri
state: Bali
Study officials:
References:
Clinical trial NCT01002404: The Use of Guide Wire in Biliary Cannulation: Angled or Straight Tipped Guide Wire?
Official title: The Use of Guide Wire in Biliary Cannulation: Angled or Straight Tipped Guide Wire?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Deep Biliary Cannulation
Keywords: ERCP
deep biliary cannulation
guide wire cannulation
post-ERCP pancreatitis
Success of deep biliary cannulation
Rate of post-ERCP pancreatitis
Time used to deep biliary cannulation
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
First posted: 2009-10-27
Enrollment: 164
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to prospectively evaluate the deep biliary cannulation in ERCP with the angled tipped guide wire or the straight tipped guide wire.

Detailed description: Patients coming to ERCP examination are being divided randomly to two different groups. The deep biliary cannulation is started with predetermined guide wire. If the cannulation does not succeed in two minutes, the procedure is continued as normal.

Eligibility criteria: Inclusion Criteria:

* the need for ERCP assessed by a specialist in gastrointestinal surgery

Exclusion Criteria:

* prior sphincterotomy
* age under 18
* age over 90
* contrast media allergy
* inability to give informed consent

Primary outcomes:
measure: The success rate of deep biliary cannulation
timeFrame: October 2010
Secondary outcomes:
measure: Frequency of post-ERCP pancreatitis
timeFrame: October 2010
measure: time spent to deep biliary cannulation
timeFrame: October 2010
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Turku University Hospital
Study officials:
affiliation: Turku University Hospital
name: Hanna R Vihervaara
role: PRINCIPAL_INVESTIGATOR
affiliation: Turku University Hospital
name: Juha Grönroos, PhD
role: STUDY_DIRECTOR
affiliation: Turku University Hospital
name: Paulina Salminen, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01894204: Determine the Frequency of a HTPPE in 5 Years (± on 1 Year) After a First Episode of Idiopathic Pulmonary Embolism.
Official title: Frequency and Risk Factors of the Lung High Blood Pressure Post-embolique in the Fall of a First Episode of Idiopathic Pulmonary Embolism. Study " PADIS HTP "
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: HTPPE
Idiopathic Pulmonary Embolism
Keywords: HTTPE
Idiopathic Pulmonary embolism
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2013-07-10
Enrollment: 235
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Forward-looking troop established(constituted) by the patients having been included in the study " PADIS EP ", PHRC on 2006 and 2009, randomized checked(controlled), double-blind, comparing an anticoagulating treatment(processing) extended by coumadine versus placebo during 18 months at patients having had a first episode of EP idiopathique treated(handled) initially 6 months by anti-vitamin K.


Eligibility criteria: Inclusion Criteria:

* Patients having ended the study PADIS EP after the visit of the end of study and having signed the consent HTP.

Exclusion Criteria:

* Refusal to grant in writing to participate in the study PADIS HTP

Primary outcomes:
measure: Frequency of a HTPPE
timeFrame: 24 months
Secondary outcomes:
measure: Mortality and cause
timeFrame: 24 months
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
city: Lannion
country: France
facility: CH de Lannion
city: Paris cedex 15
country: France
facility: Hôpital Européen Georges Pompidou
city: Rennes
country: France
facility: CHU Pontchaillou - Hôpital Sud
city: Saint-Brieuc
country: France
facility: Hôpital Yves Le Foll
city: Saint-Etienne
country: France
facility: Hôpital de Bellevue - CHU de Saint-Etienne
city: Toulouse
country: France
facility: Hôpital Rangueuil
Study officials:
affiliation: CHRU de Brest
name: Francis COUTURAUD, PU-PH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01294904: Mechanisms of Infertility and Hormonal Changes in Patients With Chronic Kidney Disease
Official title: Studies of Infertility in Patients With Chronic Kidney Disease
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Infertility
Keywords: Hormone
Sperm
Chronic kidney disease
Lead sponsor: Lund University
Sponsor class: OTHER
First posted: 2011-02-14
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: outpatient cohorts

Brief summary: Patients with chronic kidney disease (both men and women), especially those with terminal renal failure, manifest infertility. There has been demonstrated several hormonal changes in patients on dialysis. Increased levels of luteinizing hormone (LH) has been seen in men (12). In women the opposite has been reported. The number of spermatocytes is reduced and a disturbance in maturation has been observed.

This project is aimed to study the influence of uremic milieu on fertility in men and women. The hypopituitary/hypothalamus gland axis and hormonal levels will be studied.

Detailed description: Renal elimination of hormones and peptides. By using a human transplantation model the investigators will study changes in hormonal levels before and after a successful transplantation up to 12 months. Hormones: testosterone, SHBG (sex hormone binding globulin), LH (luteinizing hormone), FSH (follicle stimulating hormone), estradiol and inhibin B.

Analysis of sperm quality, concentration, motility, morphology and as well DNA-fragmentation index (DFI) in men with chronic kidney disease. In women the investigators will study the maturation of follicles via vaginal ultrasound. Controls are persons from a study at Dept of Reproductive Medicine.

Eligibility criteria: Inclusion Criteria:

* GFR-levels

Exclusion Criteria:

* \> 50 years old

Primary outcomes:
measure: concentration of sex hormone levels in plasma
timeFrame: up to three years
Secondary outcomes:
measure: sperm motility
timeFrame: up to three years
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: Dag Eckersten
city: Malmö
country: Sweden
facility: SUS, Malmö, Sweden
Study officials:
affiliation: Lund University
name: Anders Christensson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04546204: COMPARISON OF OBSTETRIC AND NEONATAL OUTCOMES OF ADOLESCENT PREGNANCİES
Official title: COMPARISON OF OBSTETRIC AND NEONATAL OUTCOMES BETWEEN SYRIAN ADOLESCENT REFUGEES AND LOCAL TURKISH ADOLESCENT CITIZENS.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adolescent Development
Pregnancy Related
Lead sponsor: Alkü Alanya Education and Research Hospital
Sponsor class: OTHER
First posted: 2020-09-11
Enrollment: 525
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: adolescent pregnancy outcomes

Brief summary: ABSTRACT

Adolescent pregnancy rates are gradually increasing in the recent decades. As a reason of war nutritional difficulties, language differences and difficulty in applying to the health institution causes lack of prenatal care. As a reason of absence of prenatal care, associated medical complications can occur. 525 adolescent women who gave birth to singletons agreed to participate in this study. Data on maternal demographic and obstetric characteristics as well as neonatal outcomes were analyzed. In conclusion, adolescent pregnancy continues to be an important social problem due to the health support needs. However, the results of our present study are important in terms of showing that the perinatal care is quietly improved in Turkey.


Eligibility criteria: Inclusion Criteria:

* 14-16 y Age

Exclusion Criteria:

* over 16 years

Primary outcomes:
measure: vaginal delivery rate
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Alkü Education and Research Hospital
Study officials:
References:
Clinical trial NCT06294704: Hybrid Closed Loop Insulin Pump and Bariatric Surgery in Patients with Type 1 Diabetes
Official title: Hybrid Closed Loop Insulin Pump and Bariatric Surgery in Patients with Type 1 Diabetes
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bariatric Surgery
Type 1 Diabetes
Keywords: Bariatric surgery
type 1 diabetes
hybrid closed-loop insulin pump
Lead sponsor: Centre Hospitalier Sud Francilien
Sponsor class: OTHER
First posted: 2024-03-05
Enrollment: 20
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: Patient with type 1 diabetes who underwent bariatric surgery and treated by hybrid closed-loop insulin pump.

Brief summary: Bariatric surgery is increasingly performed on patients with type 1 diabetes. It exposes these patients to an increased risk of hypoglycemia, including severe hypoglycemia, and of severe episodes of hyperglycemia, beyond the perioperative period. The long-term efficacy and safety of hybrid closed-loop insulin pump in these patients has not yet been published.

Detailed description: Patients with type 1 diabetes and obesity are at risk of "double diabetes". Bariatric surgery may be indicated for these patients, to combat insulin resistance. Nevertheless, post-operative patients are at risk of hypoglycemia.

At the same time, patients with type 1 diabetes can benefit from a hybrid closed loop insulin pump to improve diabetes control and reduce the occurrence of hypoglycemia.

In type 1 diabetic patients who have undergone bariatric surgery and are treated with a hybrid closed loop insulin pump, continuous glucose measurement can be studied. In the medium and long term, the efficacy and safety of this system in this context will be described.

Eligibility criteria: Inclusion Criteria:

* Major patient
* With type 1 diabetes for \> 1 year
* Obese (BMI≥30)
* Having undergone bariatric surgery
* On a hybrid closed-loop insulin pump
* Not pregnant
* No hybrid closed-loop insulin pump discontinuation for more than 45 days after surgery

Exclusion Criteria:

- Patient informed and opposed to data use

Primary outcomes:
measure: time spent within glycemic target 70-180 mg/dL
timeFrame: at 3 months
Secondary outcomes:
measure: Time spent in level 1 hyperglycemia (181-250 mg/dL)
timeFrame: at 3 months
measure: Time spent in level 2 hyperglycemia (>250 mg/dL)
timeFrame: at 3 months
measure: HbA1c
timeFrame: at 3 months
measure: Coefficient of variation
timeFrame: at 3 months
measure: Time spent in level 1 hypoglycemia (51-70 mg/dl)
timeFrame: at 3 months
measure: Time spent in level 2 hypoglycemia (< 50 mg/gdl)
timeFrame: at 3 months
Other outcomes:
Locations:
city: Corbeil-Essonnes
country: France
facility: Centre Hospitalier Sud Francilien
Study officials:
affiliation: Centre Hospitalier Sud Francilien
name: Geoffrey BOULATE, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00498004: Quality of Life (QOL) in Female Patient With Schizophrenia
Official title: Randomized, Open Label, 8-Week Study of Quetiapine and Risperidone on Quality of Life in Female With Schizophrenia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Schizophrenia
Keywords: Quality of Life
Schizophrenia
Quetiapine
Risperidone
Lead sponsor: Inje University
Sponsor class: OTHER
First posted: 2007-07-09
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to demonstrate clinical and statistical superiority of quetiapine compared to risperidone in Korean version of Heinrich's Quality of Life Scale after 8 weeks trial of drugs.

Detailed description: Prolactin related adverse events are closely related to patient's perception on their illness and quality of life . Poor subjective wellbeing induced by prolactin elevation after antipsychotic drug treatment can complicate the clinical outcomes of treatment.Quetiapine has negligible effects on the elevation of prolactin and does not produce hyperprolactinemia related adverse events such as amenorrhea, galactorrhea that may disturb quality of life in famel patient. In this Randomized, Open Label, 8-week Study, the impact of quetiapine and risperidone on quality of life in female patients with schizophrenia will be compared.

Eligibility criteria: Inclusion Criteria:

1. Diagnosis: Schizophrenia (DSM-IV)
2. Female, Age: between 18-60 years
3. Who either need first time treatment with antipsychotic drug or recently
4. Sign written informed consent

Exclusion Criteria:

1. Taking other psychiatric medications during last 30 days
2. Refractory schizophrenia
3. A current medical illness associated with sexual dysfunction
4. Previous history of no response to quetiapine or risperidone treatment
5. Previous enrolment or randomisation of treatment in the present study.
6. Participation in a clinical study during the last 90 days.
7. Pregnancy
8. Alcohol or substance abuser

Primary outcomes:
measure: QOL measured by Korean version of Heinrich's Quality of Life Scale
timeFrame: 8weeks
Secondary outcomes:
measure: Korean version of Female Sexual Function Index
timeFrame: 8 weeks
measure: Korean version of Female Sexual Distress Scale
timeFrame: 8 weeks
measure: Hormonal levels (Prolactin, Estradiol, Free Testosterone, FSH, LH
timeFrame: 8 weeks
measure: Psychopathology (Brief Psychiatric Rating Scale)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Busan Paik Hospital
Study officials:
affiliation: Clinical Trial Center, Paik hospital
name: Joo-Cheol Shim, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jung DU, Conley RR, Kelly DL, Kim DW, Yoon SH, Jang JH, Shin JG, Shim JC. Prevalence of bone mineral density loss in Korean patients with schizophrenia: a cross-sectional study. J Clin Psychiatry. 2006 Sep;67(9):1391-6. doi: 10.4088/jcp.v67n0909.
Clinical trial NCT03291704: Investigating the Effect of At Home Thermal Therapy on Dry Eye Patients With Meibomian Gland Dysfunction
Official title: PILOT STUDY: The Effect of Thermal Therapy Using a Rechargeable, Wireless Device on Meibomian Gland Dysfunction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Meibomian Gland Dysfunction
Dry Eye Disease
Keywords: Dry Eye
Thermal Therapy
Meibomian Gland Dysfunction
Lead sponsor: UMay Care Inc.
Sponsor class: INDUSTRY
First posted: 2017-09-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this pilot study is to determine the feasibility of at home thermal therapy with a wireless, portable device, as an effective management of Meibomian Gland Dysfunction.

This will be done by assessing patients for improvement in symptoms and ocular oil gland function after 4 weeks of a daily thermal therapy application.

Detailed description: This study will be a non-randomized, open label study of subjects with documented MGD. All subjects will be sent home with a wireless, portable thermal therapy device and examined pre and post treatment period. Subjects will be asked to use the device at bedtime for 5 minutes daily for 4 weeks. After treatment subjects will be re-examined and measured for clinical and symptomatic change in their MGD as well as changes to their sleep quality and anxiety index. Subjects will also be followed after treatment has been completed.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of MGD
* Minimum age 18 years

Exclusion Criteria:

* History of ocular disease, trauma, surgery (other than refractive), orbital cancer
* 3 month history of ocular infection and/or ocular inflammation not associated with dry eye
* 3 month history of any active physician administered or prescription dry eye treatment
* Pregnant, potentially pregnant or nursing

Primary outcomes:
measure: Change in Non-Invasive Tear Film Break Up Time (NITFBUT) in Seconds
timeFrame: Before and after 4 weeks of daily treatment
Secondary outcomes:
measure: Change in Ocular Surface Disease Index (OSDI) Score
timeFrame: Before and after 4 weeks of daily treatment
measure: Meibum Expressibility
timeFrame: Before and after 4 weeks of daily treatment
measure: Sleep Quality
timeFrame: Before and after 4 weeks of daily treatment
measure: State Trait and Anxiety
timeFrame: Before and after 4 weeks of daily treatment
Other outcomes:
Locations:
Study officials:
affiliation: University of Alberta
name: Hermina Strungaru, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05496504: Pulmonary Hypertension and Arrhythmia
Official title: Incidence and Prognostic Significance of (Malignant) Arrhythmias During Repetitive Holter Electrocardiograms in Patients With Pulmonary Hypertension
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Hypertension
Keywords: pulmonary hypertension
PH
arrhythmias
survival
Lead sponsor: Asklepios Neurological Clinic Bad Salzhausen
Sponsor class: OTHER
Collaborators: name: University of Giessen
First posted: 2022-08-11
Enrollment: 222
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 PH of all groups

Brief summary: Patients with pulmonary hypertension underwent (routine) Holter ECG and were screened for (malignant) arrhyhtmias. Results of Holter ECGs were correlated with clinicial and technical data (echocardiography and right heart catheterization).


Eligibility criteria: Inclusion Criteria: Holter ECG -

Exclusion Criteria: None

-

Primary outcomes:
measure: Arrhythmias during Holter ECG
timeFrame: 1-3 day(s)
Secondary outcomes:
measure: Relation between arrhythmias and PH group, echocardiographic data, right heart catheterization data.
timeFrame: 1-3 day(s)
Other outcomes:
Locations:
Study officials:
References: