louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03796416: Obesity Study to Assess Induction of Labor
Official title: Obesity Study to Assess Induction of Labor With Balloon and Cytotec: a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Induction of Labor Affected Fetus / Newborn
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2019-01-08
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There are more and more pregnant women who are obese. It is very difficult for obese women to get into labor. That is why when women are obese, half are likely to need a Cesarean delivery(C-section). Unfortunately, C-sections are more dangerous for obese women. There may be a combination of issues that cause obese women to need C-sections. We believe one of those reasons is that the womb of obese women respond differently to medications and devices compared to non-obese women. There are commonly two ways to help women get into labor. One way is a medication called misoprostol. The second way is a device called Foley balloon. In most studies, both ways are equally effective in helping women get into labor. However, these studies included everyone, and didn't focus on obese women.

So far there are no studies in this area that focus only on obese women. Therefore we need to design this study to focus just on obese women and what is the best way to help them get into labor and avoid a C-section.


Eligibility criteria: Inclusion Criteria:

* Morbidly obese patient (BMI≥40kg/m2) at admission for induction of labor Speaks English Gestational age between 37and0 weeks and 41and6 weeks Cervical exam: dilation \<4cm and Bishop score 6 or less Contractions \< 2 per 10 minutes

Exclusion Criteria:

* History of cesarean delivery Maternal contraindications to labor Fetal contraindications to labor Maternal age \<18yo Fetal growth restriction with abnormal umbilical artery Doppler indexes Cervical dilation ≥4cm or Bishop score ≥7 Contractions ≥3 per 10 minutes Non-reassuring fetal status Latex allergy

Primary outcomes:
measure: achieving complete cervical dilation
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05694416: Etoposide Plus Cisplatin Compared With Temozolomide in Patients With Glioblastoma
Official title: Etoposide Plus Cisplatin Compared With Temozolomide in Patients With Newly Diagnosed MGMT Promotor Unmethylated Glioblastoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: MGMT-Unmethylated Glioblastoma
Keywords: Etoposide Plus Cisplatin
Temozolomide
MGMT-Unmethylated Glioblastoma
Lead sponsor: Zhongnan Hospital
Sponsor class: OTHER
First posted: 2023-01-23
Enrollment: 60
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: Temozolomide provided significant and clinically meaningful benefit in MGMT gene promoter methylation glioblastoma. However, in unmethylated patients, the effect of Temozolomide is limited. The aim of this study is to compare the effect of Etoposide plus Cisplatin and Temozolomide in patients with MGMT gene promoter unmethylation glioblastoma.

Detailed description: 60 Patients with glioblastoma were recruited for this study based on the following eligibility criteria: Age between 18 and 70, performance status of 0-1 (Eastern Cooperative Oncology Group performance status), histologically confirmed MGMT gene promoter unmethylation glioblastoma, no cerebrospinal fluid and distant metastatic disease. All patients had adequate hematologic, hepatic, and renal function. Patients younger than 18 years; patients with a prior (i.e. within 5 years) or synchronous malignancy, other than non-melanoma skin cancer; and those with significant comorbidities were excluded.

60 patients were randomly divided into two groups and compared the difference of efficacy between the two groups

Eligibility criteria: Inclusion Criteria:

* Age between 18 and 70,
* performance status of 0-1 (Eastern Cooperative Oncology Group performance status),
* histologically confirmed MGMT gene promoter unmethylation glioblastoma
* no cerebrospinal fluid and distant metastatic disease.
* adequate hematologic, hepatic, and renal function

Exclusion Criteria:

* younger than 18 years;
* with a prior (i.e. within 5 years) or synchronous malignancy, other than non-melanoma skin cancer; and those with significant comorbidities

Primary outcomes:
measure: OVER SURVIVAL
timeFrame: 2 YEARS
Secondary outcomes:
measure: PFS
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Wuhan University
name: Jianyin Huang, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03756116: Effect of Papillary Epinephrine Spraying for the Prevention of Post-ERCP Pancreatitis in Patients Received Octreotide
Official title: Effect of Papillary Epinephrine Spraying for the Prevention of Post-ERCP Pancreatitis in Patients Received Sublingual Nitroglycerin: A Multi-center, Single-blind, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Post-ERCP Acute Pancreatitis
Epinephrine
Lead sponsor: The Second Hospital of Nanjing Medical University
Sponsor class: OTHER
First posted: 2018-11-28
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) is the most common complication with high costs, significant morbidity and even mortality. The major mechanisms of PEP is the papillary edema which is caused by manipulations during cannulation or endoscopic treatment. The papillary edema may cause temporary outflow obstruction of pancreatic juice, and then increase ductal pressure, resulting in the occurrence of pancreatitis. Nitroglycerin can reduce the Oddis sphincter tension, the internal pressure of the biliary tract and the pancreatic duct. Therefore, it is widely used in clinical to prevent and treat pancreatitis. Many studies found nitroglycerin might be effective in preventing PEP. And topical application of epinephrine on the papilla may reduce papillary edema by decreasing capillary permeability or by relaxing the sphincter of Oddi. There are reports that epinephrine sprayed on the papilla may be effective to prevent PEP.

The investigators therefore designed a prospective randomized trial to determine whether routine using papillary epinephrine spraying in patients received octreotide can reduce post-ERCP pancreatitis.


Eligibility criteria: Inclusion Criteria:

1. ERCP surgery is required
2. Signed inform consent form and agreed to follow-up on time.

Exclusion Criteria:

1. Acute pancreatitis.
2. Pregnancy or history of allergy to epinephrine.
3. Serious liver, kidney, heart and coagulation disorders
4. Unwilling or inability to provide consent

Primary outcomes:
measure: Incidence of post-ERCP pancreatitis in the groups
timeFrame: 48 hours after ERCP
Secondary outcomes:
measure: Others complications
timeFrame: 1 weeks after ERCP
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
name: Miao Lin
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06188416: Changes in Dynamic q Angle in Patients With Chronic Ankle Instability
Official title: Changes in Dynamic q Angle in Patients With Chronic Ankle Instability
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ankle Sprain Strain
Keywords: Kinetic chain
Ankle instability
Q-angle
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-01-03
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The participants from both genders aged between 18 and 30 years will be divided into 2 groups: a study group and a control group. The study group consists of 52 participants with chronic ankle instability, and the control group consists of 52 participants without chronic ankle instability, normal participants with no musculoskeletal disorders or history of knee disease and no obvious limb length discrepancy.

Brief summary: This study investigates the difference in dynamic Q-angle of patients with chronic ankle instability and those without.


Eligibility criteria: Inclusion criteria:

* Subjects aged between 18 and 30 years.
* Subjects with a history of LAS for at least one year before the study onset, that required at least 1-day weight-bearing restriction.
* Subjects with a self-reported tendency of ≥2 giving way episodes during 6 months before enrollment in the study.
* Subjects with a perception that the injured ankle was chronically weaker, more painful, and/or less functional than the contralateral ankle before the first LAS.
* Subjects who scored less than 24 in the Cumberland Ankle Instability Tool (CAIT), a validated ankle instability specific questionnaire of 9 items, to determine if functional ankle instability is present.

Exclusion criteria

* Subjects who had bilateral LAS
* Subjects with a history of lower extremity injury, fracture, or surgery
* Subjects who participated in supervised or unsupervised ankle rehabilitation within a year before enrollment in the study
* Subjects with LAS within 3 months before participation
* Subjects with a history of knee pain during the last 6 months.
* Subjects diagnosed with knee osteoarthritis.

Primary outcomes:
measure: Dynamic Q-angle
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Dokki
country: Egypt
facility: Faculty of Physical Therapy, Cairo University
state: Giza
Study officials:
References:
Clinical trial NCT04047316: Development and Validation of a New Digital Dermatoscope in the United States
Official title: Development and Validation of a New Digital Dermatoscope in the United States
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Skin Cancer
Lead sponsor: Barco NV
Sponsor class: INDUSTRY
First posted: 2019-08-06
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be considered for enrollment in the study when they have a lesion that is accessible to the new digital dermatoscope and are able to give informed consent (guardian in case of patients under 18 years).

Brief summary: A completely new type of digital dermatoscope has been developed in order to take a significant step forward in technology for skin cancer imaging. By means of this study a better insight can be gained of the current performance and workflow in clinical dermatoscopy. This knowledge will be used to further improve the developed technology.


Eligibility criteria: Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study.
* Male or Female, aged 18 years or above.
* Male or Female, aged less than 18 years, with informed consent of their legally authorized representative.
* Patient presenting with any visible skin lesion for dermatologist review on a body site amenable to optimal photographic imaging.
* Able and willing to comply with all study requirements.
* Patient with a skin lesion that is clinically diagnosed by a dermatologist as benign, malignant or a suspicious skin lesion requiring excisional biopsy for histological diagnosis.

Exclusion Criteria:

* Patients aged under 18 years old where the legally authorized representative is unable or unwilling to provide their informed consent.
* Patients unable to provide informed consent.
* Skin lesions in an anatomical site which is not suitable for photography including hair-obscured site, subungual lesion or inaccessible mucosal site.
* Lesion is at a site where previous surgery was undertaken.

Primary outcomes:
measure: Performance of the new device in its normal conditions of use
timeFrame: 6 months
measure: Usability of the new device
timeFrame: 1 month
measure: Safety of the new device in its normal conditions of use
timeFrame: 1 year
Secondary outcomes:
measure: Develop a database of skin images with the new device with metadata and histopathology of excised lesions
timeFrame: 1 year
Other outcomes:
Locations:
city: Chevy Chase
country: United States
facility: Dermatologic Surgery Center of Washington LLC
state: Maryland
city: Salem
country: United States
facility: Silver Falls Dermatology
state: Oregon
Study officials:
References:
Clinical trial NCT06457516: Comparison the Effectiveness of Mirror Therapy VS Music Therapy for Training in Post Stroke Hemiplegic Patients
Official title: Comparison the Effectiveness of Mirror Therapy VS Music Therapy for Balance and Gait Training in Post Stroke Hemiplegic Patients: Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemiplegia
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2024-06-13
Enrollment: 54
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: A randomized clinical trial was performed on hemiplegic post-stroke patients with a sample size of 50 (25 in each group).

Detailed description: It was a single-blinded study. Mirror therapy was given to group A and music therapy was given to group B. Our findings support the alternate hypothesis. This indicates the small effect size for BBS in group A and the moderate effect size for the gait assessment scale in favor of group A.

Eligibility criteria: Inclusion Criteria:

* ischemic and hemorrhagic post stroke hemiplegic patients
* patients of age 40-60 years
* no visual perception dysfunction

Exclusion Criteria:

* patients with fracture of upper or lower limb
* patient with comorbidities
* patients with hearing issues
* patients with cognitive disabilities
* patient with other neurological disease

Primary outcomes:
measure: BBS (berg balance scale)
timeFrame: 6 Month
measure: FGA (functional gait assessment scale)
timeFrame: 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Chaudhary Muhammad Akram Hospital
state: Punjab
Study officials:
References:
Clinical trial NCT03073616: Lung Ultrasound for the Postoperative Diagnosis of Pneumothorax in Children
Official title: Is Lung Ultrasound the Technique of Choice for the Diagnosis of Pneumothorax Following the Nuss Procedure for Pectus Excavatum?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pectus Excavatum
Lead sponsor: Istituto Giannina Gaslini
Sponsor class: OTHER
First posted: 2017-03-08
Enrollment: 66
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 66 consecutive pediatric patients undergoing Nuss procedure for Pectus Excavatum correction at Giannina Gaslini Institute, Genova, Italy

Brief summary: This study will be conducted to determine the advantages and limitations of sonography compared with chest radiography, in the detection of post procedure iatrogenic pneumothorax in patients underwent to Pectus Excavatum (PE) with Nuss repair.

Detailed description: The Nuss procedure is a minimally invasive technique for the repair of Pectus Excavatum (MIRPE).

Residual pneumothorax (PNX) is reported in more than 50% after Nuss procedure. It is a consequence of the introduction of the scope and bar in the pleural space and is considered a minor complication due to the minimal clinical consequences. It is routine practice to confirm the diagnosis of PNX with a conventional chest X-Ray either in the operating room at the end of thoracic surgery or in the recovery room unit immediately after surgery.However, anterior pneumothorax can occur and chest-X ray could not be able to detected the PNX. Nowadays lung ultrasound (LUS) allows a bedside non-invasive evaluation of the patient(with a sensitivity and specificity of 92 and 99% respectively) without exposure to ionized radiation, can be performed more quickly than chest radiography and therefore can be repeated several times without additional risks. The use of LUS in pediatric age groups is more recent, but is becoming widely utilized both in neonatal and pediatric respiratory diseases.

Bedside sonography for diagnosis of PNX has been well described in emergency and trauma medicine literature and it is resulted to be more sensitive and specific than portable anteroposterior chest radiography. Although there are few studies describing the use of ultrasound for the detection of surgical pneumothorax, none of them studied its use after Nuss Procedure.

Eligibility criteria: Inclusion Criteria:

* Patients following Nuss procedure for PE repair at Giannina Gaslini Institute

Exclusion Criteria:

* absence of informed consent from parents
* poor quality of the pre-operatory acoustic window

Primary outcomes:
measure: Detection of PNX
timeFrame: 60 minutes after the end of surgery
Secondary outcomes:
measure: Lung ultrasound and operator, composite measurement
timeFrame: Before surgery, 60 minutes after surgery and 24 hours after surgery
measure: Postoperative complications
timeFrame: 5 days after surgery
Other outcomes:
Locations:
city: Genova
country: Italy
facility: Istituto Giannina Gaslini
Study officials:
References:
Clinical trial NCT03485716: Metabolic Dynamics During Physical Activity
Official title: Metabolic Dynamics During Physical Activity Under Normobaric Normoxia or Moderate Hypoxia - a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Men and Women
Keywords: metabolism
metabolome
physical activity
hypoxia
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2018-04-02
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this study is to systematically Analyse the metabolome in capillary blood of healthy men and women at rest and during defined standardized physical activity under normobaric normoxia or hypoxia with a specific focus on metabolites and metabolic pattern related to energy metabolism. The metabolome analyses in capillary blood could give us also or more detailed insight into erythrocyte metabolic physiology because it is known for a longer time that the primary metabolism of the erythrocyte reflects its Oxygen Saturation via the glycolytic metabolites / intermediates pattern.


Eligibility criteria: Inclusion Criteria:

* healthy volunteers
* written informed consent

Exclusion Criteria:

* known cardio-vascular, lung, metabolic, endocrine, hematologic, kidney or neurologic diseases
* pregnancy, lactating period
* unability to understand study content and aims and to give written informed consent

Primary outcomes:
measure: Change in capillary lactate/pyruvate Ratio (dimension-free)
timeFrame: t = 0 min (before exercise); t = 10, 20 and 30 min during exercise; t = 50 and 60 min during recovery
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charite University Medicine, ECRC
Study officials:
affiliation: Charite University, Berlin, Germany
name: Michael Boschmann, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01851616: Oral Glucosestimulation After Gastric Bypass Surgery
Official title: Oral Glucosestimulation After Gastric Bypass Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: glucose, blood
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2013-05-10
Enrollment: 8
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The objective of this study is to examine gastric emptying and satiety hormones after oral glucose stimulation in 2 different concentrations in morbidly obese patients after Roux-en-Y-gastric-Bypass.

Detailed description: After gastric bypass many patients suffer from early and/or late dumping syndrome as a reaction to carbohydrate rich meals. Gastric emptying after bypass is accelerated and nutrition enters the intestine faster, which leads to osmotically driven fluid shifts from the blood to the lumen. Late dumping occurs 1-3 h after eating, and is caused by hyperinsulinemia and is therefore characterized by symptoms of hypoglycemia like weakness, sweating, and dizziness. Many people have both types. In most studies examining satiety hormones after oral glucose stimulation in non-operated patients, glucose loads of 50-75g are used. For a measurable GLP-1 rise a threshold of 2 kcal/min. at the intestine is needed. After gastric bypass gastric emptying is accelerated and less glucose is necessary to reach this threshold. The "threshold load" and "tolerable load without dumping symptoms" is not yet know.

Eligibility criteria: Inclusion Criteria:

* 6 weeks post gastric bypass surgery,
* non-diabetic patient

Exclusion Criteria:

* smoker,
* diabetes,
* gastrointestinal motility disorder,
* medication influencing gastric emptying

Primary outcomes:
measure: amount of oral glucose leading to increase in satiety hormones
timeFrame: 240 min.
Secondary outcomes:
measure: Amount of oral glucose leading to clinical signs of dumping
timeFrame: 240min.
Other outcomes:
measure: Gastric emptying after gastric bypass
timeFrame: 240min
Locations:
city: Basel
country: Switzerland
facility: University Hospital of Basel
Study officials:
affiliation: University of Basel
name: Christoph Beglinger, Prof.
role: PRINCIPAL_INVESTIGATOR
References: