louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02025790: POEM Versus Pneumatic Dilatation in Achalasia Cardia
Official title: A Prospective Trial Comparing POEM to Pneumatic Dilatation for Treatment of Achalasia Cardia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Achalasia Cardia
Keywords: Achalasia
POEM
Pneumatic dilatation
Eckardt score
Lead sponsor: Asian Institute of Gastroenterology, India
Sponsor class: OTHER
First posted: 2014-01-01
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare efficacy of POEM and pneumatic dilatation in treatment of achalasia cardia.

Detailed description: Achalasia is an esophageal motility disorder which involves smooth muscle of the esophagus and the lower esophageal sphincter (LES). Achalasia causes difficulty swallowing, regurgitation, and sometimes chest pain and weight loss. Endoscopic treatments of achalasia can be provided in the form of dilatation of the LES or cutting of muscle fibers (myotomy) of the esophagus and of the LES under endoscopic viewing. Dilatation in this trial is accomplished with rigiflex balloons and myotomy via Per Oral Endoscopic Myotomy (POEM). The effectiveness of treatment of achalasia using each method will be compared in this trial.

Eligibility criteria: Inclusion Criteria:

1. Achalasia with Eckardt score at least 3 (0-12 scale achalasia least-most severe)
2. Age 18-75 years
3. Willing and able to comply with the study procedures and provide written informed consent form to participate in the study written informed consent form to participate in the study

Exclusion Criteria:

1. Severe comorbid illness
2. Previous esophageal or gastric surgery
3. Pseudo achalasia
4. Achalasia with esophageal diverticula
5. Pregnancy or lactation

Primary outcomes:
measure: Clinical success
timeFrame: 3 months post procedure
Secondary outcomes:
measure: Adverse events
timeFrame: 1 week post procedure
Other outcomes:
measure: Cytokine levels
timeFrame: Pre procedure and immediately and 6 hours post procedure
measure: Long term clinical success
timeFrame: 6 and 12 months post procedure
measure: LES pressure
timeFrame: 3, 6 and12 months post procedure
measure: Quality of life
timeFrame: 3, 6 and 12 months post procedure
Locations:
city: Hyderabad
country: India
facility: Asian Institute of Gastroenterology
state: Andhra Pradesh
Study officials:
affiliation: Asian Institute of Gastroenterology (AIG)
name: D Nageshwar Reddy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04213690: A Pilot Study to Explore the Role of Gut Flora in Lupus
Official title: A Pilot Study to Explore the Role of Gut Flora in Lupus
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Lupus Erythematosus
Lupus Erythematosus, Systemic
Lead sponsor: ProgenaBiome
Sponsor class: OTHER
First posted: 2019-12-30
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have been diganosed with Lupus

Brief summary: This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records.

Detailed description: The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to Lupus.

Eligibility criteria: Inclusion Criteria:

1. Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study

   a. May be signed by parent or legal guardian in the case of minor or adult unable to provide consent
2. Male or female of all ages. (interest is given to children who present with autism or Crohn's and whose parents wish to analyze their children's gut flora. Also of interest analysis of development of the child's microbiome. In the case of autism, the younger the child, the better to correct the neurological problems if an association is found between autism and the microbiome)
3. Diagnosis of Lupus by a physician

Exclusion Criteria:

1. Refusal to sign informed consent form
2. History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy.
3. Postoperative stoma, ostomy, or ileoanal pouch
4. Participation in any experimental drug protocol within the past 12 weeks
5. Treatment with total parenteral nutrition

Primary outcomes:
measure: Correlation of Microbiome to Disease via Relative Abundance Found in Microbiome Sequencing
timeFrame: Three years
Secondary outcomes:
Other outcomes:
Locations:
city: Ventura
country: United States
facility: ProgenaBiome
state: California
Study officials:
affiliation: ProgenaBiome
name: Sabine Hazan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01321190: Pain Quality Study
Official title: Pain Quality in Individuals With Low Back Pain, Headache, and Fibromyalgia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Low Back Pain
Headache
Fibromyalgia
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2011-03-23
Enrollment: 307
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals who have a formal diagnosis of one of the three conditions studied and have received services at either or both the Harborview Medical Center and the University of Washington Medical Center.

Brief summary: One way to better understand how various treatments for pain differ is to determine the effects of these treatments on different pain qualities or characteristics. For example, pain can be described as "hot", "electrical", "cold", "achy", and "piercing." In order to determine which pain quality/qualities that a pain treatment affects, researchers must develop measures of these pain qualities or characteristics. The purpose of this study is to learn more about the different pain qualities individuals who have low back pain, headaches and fibromyalgia experience. Identifying the common qualities of pain experienced by these groups will help researchers evaluate and develop more comprehensive pain quality measures, which will ultimately help them to be able to test the effectiveness of treatments for these different pain qualities.


Eligibility criteria: Inclusion Criteria:

* Speaks and understands English;
* At least 18 years of age;
* Confirms a diagnosis from a physician or certified medical provider of one of the three medical conditions (low back pain, headache, fibromyalgia), and that pain related to this diagnosis is still bothersome.
* Has experienced bothersome pain associated with their diagnosis in the past three months of a sufficient intensity;
* English is their first and primary language.

Exclusion Criteria:

* Individuals would be excluded if they have more than one of the three pain diagnoses to be studied.

Primary outcomes:
measure: Pain Quality Assessment Scale
timeFrame: The assessment scale was administered once within a month following enrollment in the study; the assessment scale was not administered within a timeframe specific to an event or onset of condition.
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Mark P Jensen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jensen MP, Johnson LE, Gertz KJ, Galer BS, Gammaitoni AR. The words patients use to describe chronic pain: implications for measuring pain quality. Pain. 2013 Dec;154(12):2722-2728. doi: 10.1016/j.pain.2013.08.003. Epub 2013 Aug 8.
Clinical trial NCT02973490: Transanal Tube Drainage in Endoscopic Submucosal Dissection of the Colorectal Tumor
Official title: Transanal Tube Drainage in Endoscopic Submucosal Dissection of the Colorectal Tumor: A Prospective, Multi-Center, Randomized, Open-Label, Parallel Group, Superiority Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Tumor
Keywords: ESD;Transanal Tube Drainage;Colorectal Tumor
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2016-11-25
Enrollment: 1200
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: TREATMENT

Brief summary: We design the clincal trial to investigate the efficacy of transanal tube drainage in colorectal ESD.

Detailed description: Endoscopic submucosal dissection (ESD) is a technique for endoscopic tissue resection that enables endoscopists to control the depth and direction of diathermic knife incisions.Recently, the number of reports in which ESD has been successfully used to treat colorectal tumors has increased. But the complatios with colorectal ESD were higher than esophagus and stomach ESD.We design the clincal trial to investigate the efficacy of transanal tube drainage in colorectal ESD.

Eligibility criteria: Inclusion Criteria:

* Endoscopy proven colorectal polyp\>2cm, LST\>3cm, SMTs\<2cm Suitable for ESD No other organic disease of colorectal Removing a single lesion one time Informed consent

Exclusion Criteria:

* Complicated other colorectal diseases, such as,Crohn's disease Familial adenomatous polyposis With previous colorectal surgery Pregnancy or lactation Absolute contraindications to general anesthesia or prolonged pneumoperitoneum (ASA class \> III) ESD conversion to laparotomy Patients cannot receive ESD Patients and/or family members can not understand and accept this study

Primary outcomes:
measure: postoperative complications
timeFrame: 30 days post operatively
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Endoscopy Center, Zhongshan Hospital, Fudan University
state: Shanghai
Study officials:
References:
Clinical trial NCT05791890: GilteRInf 2022 Study (Gilteritinib Related Infections)
Official title: Observational Study on the Incidence of Infections in Patients With Relapsed/Refractory FMS-like Tyrosine Kinase 3 Acute Myeloid Leukemia Treated With Gilteritinib
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Myeloid Leukemia
Keywords: relapsed/refractory acute myeloid leukemia
FLT3+
FLT3 inhibitors
Gilteritinib
infections
Lead sponsor: University of Rome Tor Vergata
Sponsor class: OTHER
First posted: 2023-03-30
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Relapsed/refractory AML patients

Brief summary: The study is observational, retrospective-prospective, multicenter "real-life" study involving 26 centers belonging to the SEIFEM group. The goal of this study is to obtain a real-life experience in the management and outcome of infectious issues of patients with relapsed/resistant acute myeloid leukemia who receive Gilteritinib therapy, given that recent approval of this drug.

Detailed description: The study is observational, retrospective-prospective, multicenter "real-life" study. Regarding the retrospective part, clinical data will be collected on all patients with acute myeloid leukemia FLT3+ treated with Gilteritinib from when the drug was approved and marketed in Italy (April 2, 2020) until April 30, 2022. Enrollment in the prospective cohort will have an estimated duration of 24 months from the time of study approval. Patients enrolled in the last month will be followed for six months from the date of enrollment to check for the occurrence of any infections. For each case of a patient receiving salvage monotherapy with Gilteritinib, a control patient with relapsed/refractory FLT3+ acute myeloid leukemia on salvage chemotherapy should also be included.

Eligibility criteria: Inclusion Criteria:

Population

* All patients with FLT3+ relapsed/refractory AML to any line of therapy treated with Gilteritinib
* Patients ≥18 years of age
* Signature of appropriate informed consent

Exclusion criteria:

- Patients \< 18 years old

Primary outcomes:
measure: absolute infectious risk in patients treated with Gilteritinib, Infection events of grade 3 or more ( CTCAE v.5.0 )
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Maria Ilaria Del Principe
state: RM
Study officials:
affiliation: University of Rome Tor Vergata
name: Maria Ilaria Del Principe, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04409990: Shear Wave Elastography of Rectal Adenomas and Cancer
Official title: Shear Wave Elastography of Rectal Adenomas and Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rectal Neoplasms
Elasticity Imaging Techniques
Lead sponsor: Vejle Hospital
Sponsor class: OTHER
First posted: 2020-06-01
Enrollment: 164
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The diagnosis of rectal lesions is a challenging task, and the accuracy of the primary staging is important preoperatively. A relatively novel technology makes it possible to measure the tissue stiffness during endorectal ultrasonography.

The purpose of this study is to evaluate the diagnostic value of Shear Wave Elastography (SWE). The hypothesis is that the tissue stiffness is higher in malignant tissue than in benign lesions.

Detailed description: This study will include patients with an endoscopy verified rectal lesion referred to the radiology department for pretreatment evaluation.

During the investigation, patients will undergo magnetic resonance imaging (MRI) and endorectal ultrasonography (ERUS). During the ERUS, the tissue stiffness of the lesion and visible lymph nodes will be measured using the SWE technology.

Hypotheses:

1. Tumour stiffness measurement by SWE gives a statistically significantly higher value in malignant processes than in benign rectal tumors.
2. Tissue stiffness measurement with SWE gives a statistically significantly higher value in lymph node metastases than in reactive enlarged lymph nodes.
3. There is a statistically significant correlation between SWE and MRI apparent diffusion coefficient (ADC)

Histopathology report of surgical specimen will serve as endpoint.

Eligibility criteria: Inclusion Criteria:

* Adults above 18 years of age
* Rectal lesions discovered during endoscopy
* Lesions located no more than 15 cm above the anal verge

Exclusion Criteria:

* Non-eligibility for MRI (e.g. claustrophobia, implants)
* Preoperative radiotherapy and/or chemotherapy

Primary outcomes:
measure: SWE accuracy
timeFrame: 1 month
Secondary outcomes:
measure: SWE and ADC measurement
timeFrame: 1 week
Other outcomes:
Locations:
city: Vejle
country: Denmark
facility: Vejle Hospital
state: Region Of Southern Denmark
Study officials:
affiliation: Vejle Hospital
name: Søren R Rafaelsen, DMSc
role: STUDY_CHAIR
References:
citation: Li T, Lu M, Li Y, Li J, Hu Z, Li X, Cheng X, Jiang J, Tan B. Quantitative Elastography of Rectal Lesions: The Value ofShear Wave Elastography in Identifying Benign and Malignant Rectal Lesions. Ultrasound Med Biol. 2019 Jan;45(1):85-92. doi: 10.1016/j.ultrasmedbio.2018.09.008. Epub 2018 Oct 17.
Clinical trial NCT05622903: Effect of Cash Benefits on Health Care Utilization
Official title: Effect of Cash Benefits on Health Care Utilization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Care Utilization
Lead sponsor: Harvard Medical School (HMS and HSDM)
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
name: Cambridge Health Alliance
First posted: 2022-11-21
Enrollment: 3615
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Using data from the Chelsea Eats program, we propose to study a randomized controlled trial in which the City of Chelsea, Massachusetts held a lottery to allocate cash benefits to its residents for ten months during the first two years of the COVID-19 pandemic. We will analyze the impact of the cash benefit on health care utilization and health.


Eligibility criteria: Inclusion Criteria:

* Resident of Chelsea, Massachusetts
* Household income at or below 30% of the U.S. Department of Housing and Urban Development's Area Median Income

Exclusion Criteria:

* See inclusion criteria

Primary outcomes:
measure: Emergency department use
timeFrame: 10 months
Secondary outcomes:
measure: Behavioral health-related ED visit
timeFrame: 10 months
measure: Substance use disorder-related ED visit
timeFrame: 10 months
measure: Potentially avoidable ED visit
timeFrame: 10 months
measure: ED visit resulting in admission to the hospital
timeFrame: 10 months
measure: Outpatient service use
timeFrame: 10 months
measure: COVID vaccination
timeFrame: 10 months
measure: Hemoglobin A1c
timeFrame: 10 months
measure: Blood pressure
timeFrame: 10 months
measure: Weight
timeFrame: 10 months
measure: Cholesterol
timeFrame: 10 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Harvard Medical School
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital and Harvard Medical School
name: Sumit Agarwal, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03939403: Conventional Ovarian Stimulation vs. Single Injection Stimulation of Corifollitropin Alfa in Oocyte Donor
Official title: Conventional Ovarian Stimulation vs. Single Injection Stimulation of Corifollitropin Alfa in Oocyte Donor. A Randomized Clinical Trial. TAIL Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ovarian Stimulation
Lead sponsor: Instituto Bernabeu
Sponsor class: OTHER
First posted: 2019-05-06
Enrollment: 180
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 32
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to study the efficiency of using a single injection of Corifollitropin alfa for ovarian stimulation by initiating administration late and without further administration of follicle-stimulating hormone after the 7th day of stimulation compared to conventional ovarian stimulation using Corifollitropin alfa (drug administration 5 days after cessation of hormonal contraceptive and supplementation with follicle-stimulating hormone daily administration from the 8th day of stimulation).

This a controlled randomized clinical study and 180 patients will be recruited (90 per arm) and the primary study outcome is the number of obtained oocytes.


Eligibility criteria: Inclusion Criteria:

* Eligible for oocyte donation program
* Age between 18 and 32 years old
* BMI \>18 and \<30
* Antral follicle count \>12 (summing both ovaries)
* Presence of both ovaries
* Ability to participate in and comply with study protocol
* Signed informed consent
* No treatment with ovulation stimulators in the 3 months prior to the start of stimulation.

Exclusion Criteria:

* Diagnosis of endometriosis at any stage
* AFC \>20
* Polycystic ovary syndrome
* Concurrent participation in another study

Primary outcomes:
measure: Number of oocytes
timeFrame: At the end of stimulation
Secondary outcomes:
Other outcomes:
Locations:
city: Alicante
country: Spain
facility: Instituto Bernabeu
Study officials:
References:
Clinical trial NCT03689803: the Related Factors of Bariatric Surgery on Lipidemia
Official title: The Impact of Bariatric Surgery on Estimated Lipidemia in Chinese Obesity Patients: a Retrospective Cohort Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bariatric Surgery
Lipidemia
Lead sponsor: First Affiliated Hospital of Jinan University
Sponsor class: OTHER
First posted: 2018-09-28
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Obesity and related metabolic diseases have become a chronic disease that is a threat to human health. Bariatric surgery can effectively and long-term reduce excess body weight and relieve related metabolic diseases, including type 2 diabetes. Laparoscopic gastric bypass surgery and laparoscopic sleeve gastrectomy are commonly used in bariatric surgery. Laparoscopic sleeve gastrectomy due to simple operation, good weight loss, and metabolic disease control effect, which is more widely used. However, there are several studies that show an increased chance of gastroesophageal reflux disease after laparoscopic sleeve gastrectomy. Long-term gastroesophageal reflux may lead to Barrett's esophagus or esophageal cancer. Nowadays, the cause of gastroesophageal reflux disease after sleeve gastrectomy is not clear and precautionary measures are not precise.

In this study, prospective randomized controlled trials were conducted to explore the possible change of lipidemia after bariatric surgery and to explore ways to prevent bariatric surgery after bariatric surgery.


Eligibility criteria: Inclusion Criteria:

-For the choice of surgical approach, numerous studies have shown that BMI ≧ 45, the general choice of gastric bypass surgery, BMI \<45, you can choose sleeve gastrectomy. The remission rate for T2DM, sleeve gastrectomy has a good result for young patients with shorter duration. In the investigator's country, the BMI less than 45 is majorities.

Exclusion Criteria:

-BMI\<27.5

Primary outcomes:
measure: preoperative of choleaterol
timeFrame: Preoperate
measure: Postoperative of choleaterol at 3 months
timeFrame: 3 months
measure: Postoperative of choleaterol at 6 months
timeFrame: 6 months
measure: Postoperative of choleaterol at 1 year
timeFrame: 1 year
Secondary outcomes:
measure: Preoperative of triglyceride
timeFrame: Preoperative
measure: Postoperative of triglyceride at 3 months
timeFrame: 3 months
measure: Postoperative of triglyceride at 6 months
timeFrame: 6 months
measure: Postoperative of triglyceride at 1 year
timeFrame: 1 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The frist affiliated hospital of Jinan University
state: Guangdong
Study officials:
References: