louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02346448: Endoscopic Sphincterotomy vs. Balloon Dilation for Assessment of Pancreatitis
Official title: Endoscopic Sphincterotomy vs. Balloon Dilation for Assessment of Pancreatitis: A Prospective Randomized Multicenter Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pancreatitis
Keywords: endoscopic sphincterotomy
balloon dilation
adverse events
pancreatitis
bleeding
Lead sponsor: Helios Albert-Schweitzer-Klinik Northeim
Sponsor class: OTHER
First posted: 2015-01-27
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: One of the major elements of successful endoscopic retrograde cholangiopancreatography ( ERCP) is the timely and uncomplicated cannulation of the common bile duct (CBD) . Various factors may adversely affect the cannulation procedure of the CBD leading to complications (acute pancreatitis after ERCP, perforation of the duodenum , bleeding ). Endoscopic sphincterotomy is frequently required for interventional procedures (eg stone extraction). During sphincterotomy, incision of the orifice of the papilla will be performed by using a sphincterotome. Complications due to sphincterotomy are known: Bleeding, increased rates of acute pancreatitis, small bowel perforation and scarring with consecutive stenosis of the papilla. As an alternative to sphincterotomy, balloon dilatation using balloon catheters can be performed. As a result, bleeding complications and scarring as late effects might be prevented. Current data is limited in terms of the risk of acute pancreatitis after ERCP when using a balloon catheter.

This study aims to evaluate the incidence of acute pancreatitis and other complications after ERCP. Balloon dilatation of the papilla will be prospectively compared with endoscopic sphincterotomy in a randomized multicenter setting.


Eligibility criteria: Inclusion Criteria:

* independent indication for ERCP
* age ≥ 18 years
* patient is able to understand informed consent

Exclusion Criteria:

* S/p sphincterotomy
* pancreatic or CBD-stent in situ
* pregnant patient
* known chronic pancreatitis
* acute pancreatitis prior to intervention

Primary outcomes:
measure: acute pancreatitis
timeFrame: one to 10 days
Secondary outcomes:
measure: severity of pancreatitis using the Imrie score system (according to Imrie et al.)
timeFrame: one to 10 days
measure: endoscopic perforation
timeFrame: one to two days
measure: major bleeding
timeFrame: one to two days
Other outcomes:
Locations:
city: Göttingen
country: Germany
facility: Department of Gastroenterology, University Medical Center
state: Lower Saxony
city: Northeim
country: Germany
facility: HELIOS Albert-Schweitzer Hospital Northeim
state: Lower Saxony
city: Erfurt
country: Germany
facility: HELIOS Klinikum Erfurt
state: Thuringia
Study officials:
affiliation: Helios Albert-Schweitzer-Hospital
name: Tobias Meister, PDDr.med.
role: STUDY_DIRECTOR
affiliation: University Medical Center Göttingen
name: Volker Ellenrieder, ProfDr.med.
role: STUDY_DIRECTOR
References:
Clinical trial NCT04339348: Comparative Safety and Efficacy of Vaginal Misoprostol Versus Lidocaine-prilocaine Cream in Levonorgestrel IUD Insertion
Official title: Comparative Safety and Efficacy of Vaginal Misoprostol Versus Lidocaine-prilocaine Cream in Reducing Pain During Levonorgestrel IUD Insertion in Women Delivered Only by Cesarean Deliveries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Contraception
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-04-09
Enrollment: 210
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: the aim of the present study is to compare the safety and Efficacy of vaginal misoprostol versus Lidocaine-prilocaine cream in reducing pain during levonorgestrel IUD Insertion in women delivered only by cesarean deliveries


Eligibility criteria: Inclusion Criteria:

* women who delivered only by previous cesarean delivery and requesting LNG-IUD insertion

Exclusion Criteria:

* women who delivered vaginally, active vaginal or cervical infections and contraindications to IUD insertion or study drugs

Primary outcomes:
measure: pain during LNG-IUD insertion
timeFrame: 5 minutes
Secondary outcomes:
measure: duration of insertion
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Ahmedsamy
Study officials:
affiliation: Cairo University
name: ahmed taher, MD
role: STUDY_DIRECTOR
affiliation: Cairo University
name: sherif dahab, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cairo University
name: tarek el husseiny
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01608048: Transcutaneous Electrical Acupoint Stimulation to Improve Pregnancy Rates for Women Undergoing in Vitro Fertilization
Official title: Transcutaneous Electrical Acupoint Stimulation to Improve Pregnancy Rates for Women Undergoing in Vitro Fertilization
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Supervision of Pregnancy Resulting From In-vitro Fertilization
Keywords: In-vitro Fertilization
transcutaneous electrical acupoint stimulation
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Wuhan General Hospital of Guangzhou Military Command
First posted: 2012-05-30
Enrollment: 384
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to investigate the effect of transcutaneous electrical acupoint stimulation on pregnancy rates in women undergoing in vitro fertilization.


Eligibility criteria: Inclusion Criteria:

(1) infertile women \< 40 years of age, undergoing a fresh IVF or intracytoplasmic sperm injection (ICSI) cycle; (2) be an appropriate candidate with the potential for a lower success rate which defined as two or more previous unsuccessful ETs (fresh or frozen); (3) are willing to sign an informed consent form, indicating that they are aware of the investigational nature of this study that is in keeping with the policies of the institution; (4) willing to return to the study site for their study visits. The reason for our inclusion criteria is that women experienced several unsuccessful OAs or ETs may easily accept randomization to this study, and for whom adding TEAS or EA may significantly improve their clinical outcomes.

Exclusion Criteria:

(1) major medical illnesses (like stage III heart disease, severe hypertension, uncontrolled diabetes mellitus, HIV positivity, severe bleeding dyscrasias, etc.) possibly precluding IVF or pregnancy; (2) FSH more than 20 IU/L; (3) receiving donor eggs; (4) cutaneous lesion of certain acupoint area; (5) having been previously participated in this study or having undertaken acupuncture (in whatever modality) treatment for infertility.

Primary outcomes:
measure: clinical pregnancy rate (CPR)
timeFrame: 1 year
Secondary outcomes:
measure: Live birth rate (LBR)
timeFrame: 2 years
Other outcomes:
Locations:
city: Wuhan
country: China
facility: IVF center of Tongji Hospital,Tongji medical college,HUST
state: Hubei
Study officials:
affiliation: Huazhong University of Science and Technology
name: Cui Hong Zheng, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zheng CH, Zhang J, Wu J, Zhang MM. The effect of transcutaneous electrical acupoint stimulation on pregnancy rates in women undergoing in vitro fertilization: a study protocol for a randomized controlled trial. Trials. 2014 May 9;15:162. doi: 10.1186/1745-6215-15-162.
Clinical trial NCT06187948: An Informative Video Before Planned External Cephalic Version
Official title: An Informative Video Before Planned External Cephalic Version - Does it Reduce Maternal Anxiety and Improve Chances of Success? - a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breech Presentation
Keywords: breech presentation
external cephalic version
maternal anxiety
informative video
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2024-01-03
Enrollment: 200
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: A randomized control trial to investigate whether an informative video before planned external cephalic version reduces maternal anxiety and improves chances of success.

Detailed description: Women with a breech presentation scheduled to undergo an external cephalic version that meet the criteria are recruited in the Emergency Room by offering every woman that is scheduled to undergo an external cephalic version to participate. Women who agree to participate are asked to sign an inform consent, and are randomized to intervention group and control group. In the Emergency Room sonographic data is collected including amniotic fluid index, engaged presenting part, sonographic and clinical estimation of fetal weight, place of the placenta and various angles between the fetus and the bladder (These data are collected for the study). All participants in the intervention group watches an informative video on recruitment. This video describes in detail the expected external cephalic version process.

Before the external cephalic version and an hour after a successful or an unsuccessful external cephalic version the situation-specific anxiety is measured using the State-Trait Anxiety Inventory score (Attached).

Eligibility criteria: Inclusion Criteria:

* Women between ages 18-45
* with a singleton gestation
* at gestational week of 36 weeks 0 days until 38 weeks 0 days
* who admitted labor word for external cephalic version .

Exclusion Criteria:

* Women who had a past cesarean section
* Women with oligohydramnios (Amniotic fluid index \< 5 cm)
* Women who had a past external cephalic version
* Women with a failed external cephalic version in current pregnancy
* Women who take medication for depression/anxiety disorders
* Women with a complicated pregnancy including fetal anomalies, polyhydramnios...

Primary outcomes:
measure: higher success rates.
timeFrame: 4 years
Secondary outcomes:
measure: impact of watching an informative video before external cephalic version on maternal anxiety levels
timeFrame: 4 years
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Meir Medical Center
Study officials:
affiliation: Meir Hospital
name: Dorit Ravid, Dr
role: STUDY_DIRECTOR
References:
Clinical trial NCT00764348: Evaluation of Wound Biofilm in Acute and Chronic Wounds
Official title: Evaluation of Wound Biofilm in Acute and Chronic Wounds
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Wounds
Keywords: Acute and Chronic Wounds
Lead sponsor: Southwest Regional Wound Care Center
Sponsor class: OTHER
First posted: 2008-10-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Acute and Chronic Wounds

Brief summary: Patients who present to a wound care center for management of their wounds will be evaluated clinically to establish if their wounds are chronic or acute. These patients will undergo standard of care management of their wounds. If debridement is indicated for the patient, the patient will be asked to participate in a study. Once the standard of care debridement is complete, the material debrided from the wound, instead of being discarded into a biohazard bag, will be prepared for shipment. The samples will then be shipped to the Center for Biofilm Engineering where microscopic evaluation will be conducted on the material. Conclusion will be made from that analysis.

Detailed description: A planktonic concept of the bacteria present on the surface of a chronic wound is no longer viable. Microscopic studies show that biofilm is present on chronic wounds yet does not seem to be prominent on the surface of acute wounds. Biofilm is able to neutralize our host defenses and commandeer host systems, and possesses an impressive array of defenses and virulence factors. Clinically we see a significant difference in the healing behavior between chronic and acute wounds. Also, suppression of biofilm using multiple simultaneous strategies including debridement, anti-biofilm agents, specific biocides, antibiotics and advanced technologies improves wound healing. This suggests biofilm plays an important role in delayed wound healing.


Primary outcomes:
measure: It is important for all wound care providers to firmly grasp the wound biofilm concept, its importance in delayed wound healing, and how it differs from a planktonic bacterial concept.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03415048: Longitudinal Study of Children With Concussions
Official title: Longitudinal Study of Children With Concussions: 3-year Follow-up of Cognitive and Emotional Function, Return to Sports, and Risk of Re-injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Concussions
Lead sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
Sponsor class: OTHER
First posted: 2018-01-30
Enrollment: 500
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children Ages 8-17 who present to one of the Lurie Sports Medicine clinics for care of a concussion.

Brief summary: For children and adolescents who have had a concussion resulting in prolonged symptoms (\>3 months), the investigators will:

1. Measure post-concussion symptoms, cognitive and emotional function during the 3 years post-injury.
2. Determine length of recovery and frequency of return to prior level of sports participation.
3. Determine the incidence of and risk factors for subsequent concussion during the 3 years post-injury.


Eligibility criteria: Inclusion Criteria:

1. Patients between the ages of 8-17 years old who present to one of the Lurie Sports Medicine clinics for care of a concussion.
2. English-speaking patients

Exclusion Criteria:

1. Patients outside of the 8-17 years old age range
2. Patients who show structural abnormalities on neuroimaging.
3. Non-English speaking patients

Primary outcomes:
measure: Long-Term Effects of Concussion
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Ann & Robert H. Lurie Children's Hospital of Chicago
state: Illinois
Study officials:
affiliation: Ann & Robert H Lurie Children's Hospital of Chicago
name: Cynthia LaBella
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03183726: A Follow-up Study to Evaluate the Safety of ALLO-ASC-DFU in ALLO-ASC-DFU-101 Clinical Trial
Official title: A Follow-up Study to Evaluate the Safety for the Patients With ALLO-ASC-DFU Treatment in Phase 1 Clinical Trial of ALLO-ASC-DFU-101
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Foot Ulcer
Lead sponsor: Anterogen Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-06-12
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subject is enrolled who are treated with ALLO-ASC-DFU sheet in phase 1 clinical trial of ALLO-ASC-DFU-101.

Brief summary: This is an open-label follow up study to evaluate the safety for the subjects with ALLO-ASC-DFU treatment in phase 1 clinical trial (ALLO-ASC-DFU-101) for 23 months.

Detailed description: This is an open-label follow up study to evaluate the safety for the subjects with ALLO-ASC-DFU treatment in phase 1 clinical trial (ALLO-ASC-DFU-101) for 23 months.

ALLO-ASC-DFU is a hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells. Adipose-derived stem cells have anti-inflammatory effect and release growth factors such as vascular endothelial growth factor (VEGF) and hepatocyte growth factor (HGF), which can enhance wound healing and regeneration of new tissue, finally may provide a new option in treating a Diabetic Foot Ulcer.

Eligibility criteria: Inclusion Criteria:

1. Subjects who are treated with ALLO-ASC-DFU sheet in phase 1 clinical trial of ALLO-ASC-DFU-101.
2. Subjects who are able to give written informed consent prior to study start and to comply with the study requirements.

Exclusion Criteria:

1. Subjects who are considered not suitable for the study by the principal investigator (For example, Subjects requiring surgical procedure on target site).

Primary outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: up to 24 months
Secondary outcomes:
measure: Wound size and depth measurement
timeFrame: 6, 12, 24 months
Other outcomes:
Locations:
Study officials:
affiliation: Asan Medical Center
name: Hyun-suk Suh, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00830726: Water- and Salt-homeostasis in Healthy Humans, and in Patients With Heart- or Lung Disease
Official title: Water-and Salt-homeostasis in Healthy Humans, and in Patients With Heart- or Lung Disease, Evaluated by the Excretion of Aquaporin-2 and Epithelial Sodium Channels in the Urine
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Healthy Volunteers
Heart Failure
Aortic Stenosis
Ischemic Heart Disease
Pulmonary Hypertension
Keywords: Aquaporin
Epithelial Sodium Channels
Heart Failure
Valvular heart disease
Ischemic heart disease
Lead sponsor: Kolding Sygehus
Sponsor class: OTHER
Collaborators: name: Regionshospitalet Holstebro, Holstebro, Denmark
name: Odense University Hospital
First posted: 2009-01-28
Enrollment: 150
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers and Outpatients and admitted patients in Kolding Hospital and Odense Universitetshospital

Brief summary: The purpose of the study is to determine whether the excretion of renal water- and salt-channels in the urine reflects the handling of water and salt in the kidneys, and whether the excretion can be used to monitor and/or predict the effects of treatment of certain heart or lung diseases.

Detailed description: The purpose of the study is to determine whether the excretion of renal water- and salt-channels (Aquaporin-2 and Epithelial Sodium Channels) in the urine accurately reflects the handling of water and salt in the distal tubules af the kidneys, and whether quantification of these channels in the urine is useful to monitor and/or predict the effects of pharmacologic or surgical treatment of Heart Failure and heart failure-related diseases (Aortic stenosis, acute and chronic ischemic heart disease or pulmonary hypertension)

Eligibility criteria: Inclusion Criteria:

* Symptomatic heart failure
* Severe valvular aortic stenosis
* Acute Coronary Syndrome
* Medically refractory chronic angina pectoris or pulmonary hypertension with preserved left ventricular function

Exclusion Criteria:

* Pregnancy
* Drug abuse
* Malignant disease
* Significant disease of other organs including endocrine diseases

Primary outcomes:
measure: Differences in excretion of Aquaporin-2 in urine
timeFrame: 6 months
Secondary outcomes:
measure: Differences in excretion of Epithelial Sodium Channels in urine
timeFrame: 6 months
Other outcomes:
Locations:
city: Kolding
country: Denmark
facility: Kolding Hospital
Study officials:
affiliation: Kolding Hospital, Kolding, Denmark
name: Ole Nyvad, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03464526: A Study of the Efficacy and Safety of Orvepitant in Subjects With Pruritus Associated With Atopic Dermatitis
Official title: A Double-Blind, Randomised, Placebo Controlled Study of the Efficacy and Safety and Pharmacokinetics of Orvepitant in Subjects With Pruritus Associated With Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Pruritus
Atopic Dermatitis
Lead sponsor: Nerre Therapeutics Ltd.
Sponsor class: INDUSTRY
First posted: 2018-03-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
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 determine the effectiveness of three doses of orvepitant, taken once a day, in the treatment of pruritus associated with atopic dermatitis.

Detailed description: A multi-center, double-blind, randomized, parallel group, placebo-controlled dose range study in subjects with pruritus associated with atopic dermatitis.

Doses of orvepitant (10 mg/day, 20 mg/day and 30 mg/day) and placebo will be investigated in four parallel groups.

Each group will compromise of approximately 100 subjects, randomized 1:1:1:1 (approximately 400 subjects in total).

All subjects will enter a two-week screening period to determine eligibility. Eligible subjects will be randomized at the Baseline/Day 1 visit and enter a 12-week double-blind dosing period. During this period there will be four visits at Weeks 2, 4, 8 and 12. There will be a final safety follow-up visit four weeks after the end of the treatment period.

Eligibility criteria: Key Inclusion Criteria:

* Documented diagnosis of Atopic Dermatitis for ≥ 6 months confirmed by either the UK Working Party definition or the Hanifin definition
* Subjects must have chronic (\> 6 months) pruritus which is unresponsive or inadequately responsive to current therapies such as topical steroids or antihistamines
* Subjects must have atopic dermatitis with a severity \> 3 on the IGA and EASI ≥12 at Screening visit/Visit 1

Key Exclusion Criteria:

* Presence of, or history of, any other inflammatory dermatosis or skin conditions which may cause pruritus
* Any other possible cause for pruritus eg systemic, neurological, idiopathic, or metabolic
* Acute super-infection of AD lesions requiring treatment with antibiotics within 4 weeks of Visit 2
* Inability to comply with the use of prohibited and allowed medications as described in the protocol.

Primary outcomes:
measure: Change in Itch Intensity - Numeric Rating Scale
timeFrame: Week 12
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: