louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03812406: Comparison of FAUCS vs. Misgav Ladach
Official title: Comparison Between French Ambulatory Cesarean Section to The Misgav-Ladach Technique - Double Blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain, Postoperative
Ambulation Difficulty
Keywords: cesarean
Lead sponsor: Bnai Zion Medical Center
Sponsor class: OTHER_GOV
First posted: 2019-01-23
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to compare two techniques for performing a cesarean delivery: Misgav Ladach versus French Ambulatory Cesarean Section (FAUCS). The second techniques has been claimed to reduce post-operative pain, the need for analgesics, and reduce the time for ambulation. Such comparison has not been done so far, and this study will examined if indeed the FAUCS techniques offers any advantages.

Detailed description: The FAUCS technique for performing a cesarean section has been described by a French group several years ago, and is claimed to reduce postoperative pain and increase ambulation. With this technique, after making the transverse skin incision, the fascia is opened vertically and to the left of the linea alba. The left rectus abdominis muscle is then pushed laterally, and the abdominal cavity is entered. The uterine incision in performed as usual. Due to the reduced incision size, a special spatula is used to facilitate extraction of the fetal head in some cases. No urinary catheter is used during or after the operation, and fluid administration is restricted during the procedure. The patient is encouraged to get out of bed 3-4 hours post surgery. This technique for performing a cesarean section will be compared with the traditional (Misgav Ladach technique) in terms of post-operative pain, need for analgesics, ambulation, neonatal outcome, and perioperative complications.

Eligibility criteria: Inclusion Criteria:

* patients scheduled for a cesarean section
* term pregnancy: 37-42 weeks
* singleton pregnancy
* age 18 and above
* patients capable of signing an informed consent

Exclusion Criteria:

* multiple pregnancy
* emergency cesarean
* previous 3 cesareans and above
* placenta accreta
* uterine myomas in the lower segment
* fetal growth restriction
* fetal anemia
* preeclampsia
* women scheduled for general anesthesia

Primary outcomes:
measure: Composite maternal adverse outcome
timeFrame: 24 hours post surgery
Secondary outcomes:
measure: Length of surgery
timeFrame: 24 hours
measure: Blood loss (ml) during surgery
timeFrame: 24 hours
measure: Birthweight
timeFrame: immediately after birth
measure: Cord pH
timeFrame: immediately after birth
measure: Birth trauma
timeFrame: 24 hours
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Bnai-Zion Medical Center
Study officials:
References:
Clinical trial NCT00090506: Yoga for Treating People at Risk for Diabetes or With Both HIV and Depression
Official title: Yoga, Health, and Meditation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV Infections
Diabetes
Depression
Keywords: Yoga
Meditation
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH)
Sponsor class: NIH
First posted: 2004-08-27
Enrollment: 50
Sex: ALL
Minimum age (years): 14
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to plan and develop an international collaboration for research on the health effects of yoga. This study will also determine the effects of yoga on people who are at an increased risk for developing diabetes and people with both HIV and depression.

Detailed description: In recent years, western health practitioners have become increasingly aware of the potential health benefits of yoga. This study will comprise two substudies that will evaluate the effects of yoga in two distinct populations.

Participants in the first study will be people who are at risk for developing diabetes; participants in the second study will be people with both HIV and depression. All participants will practice yoga 3 to 6 days per week for 3 months. Blood collection will be done and weight and blood pressure measurements will be taken in study 1 participants; questionnaires will be used to measure depression and stress in study 2 participants. All study participants will be assessed at entry and at 3 and 6 months.

Eligibility criteria: Inclusion Criteria for Study 1 Participants:

* Meet certain laboratory requirements

Inclusion Criteria for Study 2 Participants:

* HIV infected
* Able to walk at least 50% of the time

Inclusion Criteria for All Participants:

* Written informed consent of parent/guardian, if applicable

Exclusion Criteria for Study 2 Participants:

* Require antiretroviral therapy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bangalore
country: India
facility: Swami Vivekananda Yoga Anusandhana Samsthana (SVAYSA)
Study officials:
affiliation: UCSF Positive Health Program
name: Frederick M. Hecht, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: McDermott KA, Rao MR, Nagarathna R, Murphy EJ, Burke A, Nagendra RH, Hecht FM. A yoga intervention for type 2 diabetes risk reduction: a pilot randomized controlled trial. BMC Complement Altern Med. 2014 Jul 1;14:212. doi: 10.1186/1472-6882-14-212.
Clinical trial NCT01286506: Observational Study of Blood Pressure Measurements and Continuous Dialysis
Official title: Observational Study Evaluating the Hemodynamic Relationship Between Volume Removal and Pulse Pressure Variation During Renal Replacement Therapy
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Kidney Failure
Respiratory Failure
Critical Illness
Shock
Keywords: Pulse pressure variation
Continuous venovenous hemodialysis
Volume status
Critical care
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2011-01-31
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult ICU patients requiring CVVHD who have an indwelling arterial line.

Brief summary: Dialysis is used to control the fluid balance and metabolic state of patients with kidney disease. Control of the metabolic state, via electrolytes, can be monitored using labs that are routinely drawn from patients undergoing continuous hemodialysis. Control of fluid removal is much more difficult. This study aims to determine whether changes in the blood pressure associated with breathing correlate with or predict intolerance to fluid responsiveness with continuous dialysis.

We hypothesize that a measurement of changes in blood pressure with breathing called arterial pulse pressure variation may be able to predict the ability to remove fluid during continuous renal replacement therapy.


Eligibility criteria: Inclusion Criteria:

* age \> 17 years old
* CVVHD renal replacement therapy
* indwelling arterial line

Exclusion Criteria:

* age \< 18 years old
* pregnancy
* temperature \< 34°C
* severe mechanical ventilator dyssynchrony
* cardiac arrhythmias precluding automated PPV measurement by ICU monitors
* non-pulsatile cardiac flow
* open thoracic cavity

Primary outcomes:
measure: Predictive value of pulse pressure variation for tolerance of fluid removal on CVVHD
timeFrame: Iterative 24 hr periods for the duration of CRRT
Secondary outcomes:
measure: Increased doses of vasoactive agents on CRRT
timeFrame: Iterative 24 hr periods for the duration of CRRT
measure: Inability to meet goal ultrafiltration rate
timeFrame: Iterative 24 hr periods for the duration of CRRT
measure: Hypotensive events on CRRT
timeFrame: Iterative 24 hr periods for the duration of CRRT
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The University of Chicago Medical Center
state: Illinois
Study officials:
affiliation: University of Chicago
name: Michael O'Connor, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Chicago
name: Jay L Koyner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00212706: Controlled Study of ONO-8025 (KRP-197) in Patients With Overactive Bladder in Japan
Official title: Controlled Study of ONO-8025 (KRP-197) in Patients With Overactive Bladder in Japan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Overactive Bladder
Keywords: ONO-8025, KRP-197, overactive bladder, antimuscarinic
Lead sponsor: Ono Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
First posted: 2005-09-21
Enrollment: 400
Sex: ALL
Minimum age (years): 20
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 evaluate the efficacy and safety of ONO-8025 (KRP-197) in patients with overactive bladder.


Eligibility criteria: Inclusion Criteria:

1. Patients who are 20 years old or over with overactive bladder
2. Total number of urinary incontinence episodes per week is 5 or over
3. Mean number of micturition per day is 8 or over
4. Mean number of urinary urgency episodes per day is 1 or over
5. Other inclusion criteria as specified in the study protocol

Exclusion Criteria:

1. Patients with genuine stress incontinence
2. Patients suffering from complications such as bladder tumor, bladder stone and urinary tract infection
3. Patients who have undergone surgical operation of urinary and/or genital organs within 6 months prior to the study
4. Patients suffering from complications for which anticholinergics are contraindicated
5. Other exclusion criteria as specified in the study protocol

Primary outcomes:
measure: Total number of urinary incontinence episodes per week
Secondary outcomes:
measure: Number of micturition per day, number of urinary urgency episodes per day, volume voided per micturition and QOL
Other outcomes:
Locations:
Study officials:
affiliation: Ono Pharmaceutical Co. Ltd
name: Project Leader, Development Planning
role: STUDY_DIRECTOR
References:
Clinical trial NCT04312919: Cleveland Clinic Families Get Fit (CCFit) : A Family-based Activity-Monitor Intervention in Pediatric Obesity
Official title: Cleveland Clinic Families Get Fit (CCFit) : A Family-based Activity-Monitor Intervention in Pediatric Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Childhood
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2020-03-18
Enrollment: 63
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a randomized prospective study to evaluate the effectiveness of a family-based intervention using activity-monitors (I.e. Fitbits) in children and adolescents aged 8-18 years with a BMI greater than or equal to 95%ile who attend the Cleveland Clinic multidisciplinary "Be Well" pediatric obesity clinic.


Eligibility criteria: Inclusion Criteria:

* Be Well patient
* Age 8\*-18 years
* BMI \> 95%ile
* English speaking

Exclusion Criteria:

* Uncontrolled asthma
* Orthopedic or other medical issue limiting mobility
* Participant has worn an activity-monitor in the past 6 months (ok if parents wear)

Primary outcomes:
measure: Exercise Capacity
timeFrame: Change from Baseline Six Minute Walk Distance through study completion (up to 33 weeks)
Secondary outcomes:
measure: Weight
timeFrame: Change from Baseline weight through study completion (up to 33 weeks)
measure: Fitbit Data
timeFrame: Change in steps per day wearing Fitbit and after 1 week Goal Setting Steps
measure: Height
timeFrame: Change from Baseline height through study completion (up to 33 weeks)
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
References:
Clinical trial NCT00324519: Randomized Trial Comparing Misoprostol and Foley Bulb for Pregnancy Termination in the Second Trimester
Official title: Randomized Trial Comparing Misoprostol and Foley Bulb for Pregnancy Termination in the Second Trimester
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pregnancy Trimester, Second
Induced Abortion
Keywords: second trimester
pregnancy termination
misoprostol
foley bulb
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2006-05-11
Enrollment: 30
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare two methods of pregnancy termination on the time to delivery in the second trimester.

Detailed description: Medical termination in the second trimester is performed for many indications. Successful termination is dependant on ripening of the cervix prior to labor induction. Multiple methods of cervical ripening and labor induction have been used for pregnancy termination in the second trimester. These two methods have different mechanisms of action. This study seeks to evaluate the effectiveness of these two methods.

Eligibility criteria: Inclusion Criteria:

* indication for pregnancy termination, gestational age from 13-27 weeks

Exclusion Criteria:

* multiple gestation, previous uterine surgery, rupture of membranes, latex allergy

Primary outcomes:
measure: Time to vaginal delivery
Secondary outcomes:
measure: Rate of chorioamnionitis
measure: Rate of maternal fever
measure: Rate of postpartum hemorrhage
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Shands Hospital at the University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Keri A Baacke, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04613219: Correlation Between the Change of Peripheral Lymphocyte Subsets and Clinically Amyopathic Dermatomyositis Combined With Rapidly Progressive Interstitial Lung Disease
Official title: Correlation Between the Change of Peripheral Lymphocyte Subsets and Clinically Amyopathic Dermatomyositis Combined With Rapidly Progressive Interstitial Lung Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Clinically Amyopathic Dermatomyisitis(CAMD)
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2020-11-03
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient with Clinically Amyopathic Dermatomyisitis combined with Rapidly Progressive Interstitial Lung Disease

Brief summary: Acute respiratory distress syndrome (ARDS) occurs in Clinically Amyopathic Dermatomyisitis(CADM) combined with Rapidly Progressive Interstitial Lung Disease(RPILD) within 1-3 months, which leads to death of patients and is difficult to treat. Even if high doses of glucocorticoids are ineffective, there is no recommended treatment for such patients, which is a huge medical challenge.Lymphopenia is an independent risk factor for death in CADM-RPILD, but the cause of lymphopenia is unclear.In this study, the level of lymphocyte subsets in peripheral blood was detected by flow cytometer, in order to further clarify the pathogenesis of the disease, to facilitate clinical guidance of treatment, and to improve the survival rate of patients.In addition, studies have shown that INF-α levels are significantly increased in CADM patients combined with RPILD and are a poor prognostic factor for CADM-RPILD, suggesting that the interferon system plays a role in the pathogenesis of CADM and can be used as an evaluation index of the severity of CADM-RPILD.In this study, the levels of relevant cytokines including INF and IL-2, IL-17, IL-18, IL-6 were detected simultaneously, and the relationship between disease activity and lymphocyte subsets was analyzed, and the changes of lymphocyte subsets after Tofacitinib treatment were determined in order to facilitate clinical guidance of treatment.


Eligibility criteria: Inclusion Criteria:

1. Age≥18 years old,≤80years old,no gender limit;
2. CADM of diagnosis according to Sontheimer diagnostic criteria;
3. combined with Rapidly Progressive Interstitial Lung Disease

Exclusion Criteria:

1. Age\<18years old，\>80years old;
2. potential malignant tumor

Primary outcomes:
measure: The level of a lymphocyte in a lymphocyte subset correlates with disease activity.
timeFrame: 3 month
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qianfoshan Hospital
state: Shandong
Study officials:
References:
Clinical trial NCT01400919: DURABILITY™ Iliac Study
Official title: Protege® EverFlex™ and GPS™ Self-Expanding Iliac Study (DURABILITY™ Iliac)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Arterial Disease
Claudication
Keywords: Peripheral arterial disease
claudication
stent
EverFlex
GPS
Iliac Artery
Lead sponsor: Medtronic Endovascular
Sponsor class: INDUSTRY
First posted: 2011-07-25
Enrollment: 75
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 DURABILITY Iliac study is a prospective, multi-center, non-randomized study confirming the safety and effectiveness of stenting using the Protégé® EverFlex™ and Protégé® GPS™ Self-Expanding Stent Systems for the treatment of atherosclerotic lesions in the common and/or external iliac arteries.


Eligibility criteria: Inclusion Criteria:

* Patient has claudication as defined by a Rutherford Clinical Category Score of 2, 3 or 4.
* Evidence of ≥ 50% stenosis, restenosis or occlusion of target lesion(s) located in the common iliac artery and/or external iliac artery.
* Willing to comply with all follow-up evaluations at the specified times.
* Provides written informed consent prior to enrollment in the study.

Exclusion Criteria:

* Previous implantation of stent(s) in the target vessel.
* Received endovascular treatment of the target lesion within six months prior to the index procedure.
* Known hypersensitivity to contrast material that cannot be adequately pretreated.
* Known hypersensitivity to nickel-titanium.
* Life expectancy of less than 12 months

Primary outcomes:
measure: Major Adverse Event Rate
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Peter L. Faries, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Holy Name Medical Center
name: John H. Rundback, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02017119: Comparison Between Lactulose and Lactulose-Paraffin in Cirrhotic Patients
Official title: Comparison Between Lactulose and Lactulose-Paraffin in Cirrhotic Patients: Impact on the Recurrence of Encephalopathy, Tolerance and Adherence to Treatment, Costs, and Quality of Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cirrhosis
Hepatic Encephalopathy
Lead sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Sponsor class: OTHER
First posted: 2013-12-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hepatic encephalopathy (HE) is an important complication of liver cirrhosis. Lactulose is a first line treatment for HE, but the adherence to this treatment is relatively low, due to side effects such as diarrhea, distention, etc.

Detailed description: Lactulose is a first line treatment for HE, but the adherence to this treatment is relatively low due to side effects. Lactulose-paraffin recently available in the market can be used for the treatment of HE, and possibly have fewer side effects.

The aim of this study was to compare the adherence of the treatment of lactulose and lactulose-paraffin.

Eligibility criteria: Inclusion Criteria:

* Liver cirrhosis
* History of an event of hepatic encephalopathy.
* Ambulatory patients

Exclusion Criteria:

* Alcoholism with active ingest of alcohol in the last 6 months
* Labour turn-overs
* Pregnancy
* Personal history of surgery in the last 4 weeks
* Spontaneous bacterial Peritonitis
* Use of neuropsychiatric drugs
* Neuropsychiatric disorders (Schizophrenia, bipolar disorder, major depression, dementia and Attention-deficit hyperactivity disorder)
* Thyroid disorders without replacement therapy
* Renal failure
* Hepatic or renal transplant
* Personal history of hepatocellular carcinoma
* Placement of transjugular intrahepatic portosystemic shunt
* Use of a probiotic in the last 6 month

Primary outcomes:
measure: Adherence to treatment
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Study officials:
References:
Clinical trial NCT05567718: The Relationship Between Fasting Time and Delirium
Official title: The Relationship Between Fasting Time and Emergency Delirium in Pediatric Sedation Undergoing Magnetic Resonance Imaging
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Delirium
Sedation Complication
Magnetic Resonance Imaging
Fasting
Keywords: Emergence delirium
pediatric
preoperative fasting
magnetic resonance imaging
Lead sponsor: Bursa Yüksek İhtisas Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2022-10-05
Enrollment: 1
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: children between the age group 2-6 years of American Society of Anesthesiologists (ASA) physical status I or II, patients undergoing MRI under sedation

Brief summary: We investigated the relationship between fasting times and delirium in children undergoing MRI under anesthesia. Paediatric Anaesthesia Emergence Delirium (PAED) scale, last oral intake time and type of food (solid-liquid) and fasting time, laryngospasm, desaturation (SpO2 \<95%), bradycardia, allergy, nausea and vomiting were recorded.


Eligibility criteria: Inclusion Criteria:

* children between the age group 2-6 years of American Society of Anesthesiologists (ASA) physical status I or II
* Patients undergoing MRI under sedation

Exclusion Criteria:

* ASA 3-4-5
* under 2 years old, over 6 years old
* cognitive or psychological disorder
* serious central nervous system diseases, including a brain tumor or uncontrolled seizures
* type 1 diabetes
* detection of ≤ 50 mg/dl in fasting blood glucose measurement
* whose parents did not want to participate in the study

Primary outcomes:
measure: Pediatric Anesthesia Emergence Delirium scale
timeFrame: during the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Yıldırım
country: Turkey
facility: Bursa Yüksek Ihtisas Training and Research Hospital
state: Bursa
Study officials:
References: