louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00590928: Gastric pH in Critically Ill Patients
Official title: Effect of Intravenous Esomeprazole Versus Ranitidine on Gastric pH in Critically Ill Patients - a Prospective, Randomized, Double-Blind Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Critically Ill Patients
Indication for Stress Ulcer Prophylaxis
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2008-01-11
Enrollment: 75
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: H2-receptor antagonists are the gold standard for stress ulcer prophylaxis in critically ill patients. Various studies demonstrated superiority of proton pump inhibitors over H2-receptor antagonists in increasing gastric pH and in healing gastric acid-dependent diseases. It is unknown, whether proton pump inhibitors are more effective in increasing gastric pH than H2-receptor antagonists in critically ill patients requiring stress ulcer prophylaxis.

Detailed description: Gastric pH is measured continuously for 72 hours with a pipolar microelectrode placed between 7 and 15cm below the lower esophageal sphincter.

Eligibility criteria: Inclusion Criteria:

* critically ill patients
* indication for stress ulcer prophylaxis
* gastric pH \< 4

Exclusion Criteria:

* gastrointestinal bleeding
* gastric pH \> 4

Primary outcomes:
measure: the percentage of time with gastric pH > 4
timeFrame: 72 hours
Secondary outcomes:
measure: median gastric pH
timeFrame: 72 hours
measure: incidence of gastrointestinal bleeding
timeFrame: 72 hours
measure: incidence of ventilator associated pneumonia
timeFrame: ICU stay
measure: the percentage of time with an gastric pH > 5
timeFrame: 72 hours
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna, Department of Medicine III, ICU
Study officials:
affiliation: Medical University of Vienna
name: Christian Madl, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05330728: Comparison of the Effects of Abdominal Massage and Kinesio Taping in Women With Chronic Constipation
Official title: Comparison of the Effects of Abdominal Massage and Kinesio Taping in Women With Chronic Constipation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Constipation
Lead sponsor: Ankara Yildirim Beyazıt University
Sponsor class: OTHER
First posted: 2022-04-15
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare the effects of abdominal massage and kinesio taping on constipation severity, quality of life, bowel habits and perception of recovery in women with chronic constipation.

Detailed description: Constipation is not a disease but a subjective symptom characterized by inadequate defecation, the definition of which varies from person to person. It is known that abdominal massage, which is one of the physiotherapy approaches, reduces the severity of gastrointestinal symptoms and increases bowel movements. Kinesio taping applied for constipation can also increase bowel movement, increase the frequency of defecation and decrease the duration of defecation. However, there is a need for studies comparing the effects of these two different applications.

Eligibility criteria: Inclusion Criteria:

* 18 to 65 years of age
* Having been diagnosed with chronic constipation according to the Rome 4 diagnostic criteria by a gastroenterologist
* Being volunteer

Exclusion Criteria:

* Concomitant colon or gastrointestinal problems
* Body mass index \>35 kg/m2
* Those who have difficulty defecating, those with anorectal dyssynergia
* Being pregnant
* Having neurological, metabolic and/or malignant disease
* Having an open wound, mass, infection and/or hernia in the area to be massaged
* Having abdominal surgery or abdominal radiotherapy in the last 1 year
* Having a mental problem that prevents cooperation
* Taking laxative therapy at least 4 weeks before participating in the study
* To have received physiotherapy and rehabilitation applications related to constipation in the last 1 year

Primary outcomes:
measure: Constipation severity
timeFrame: change from baseline at 4 weeks
Secondary outcomes:
measure: Life quality
timeFrame: change from baseline at 4 weeks
measure: Bowel habits
timeFrame: change from baseline at 4 weeks
measure: Stool consistency
timeFrame: change from baseline at 4 weeks
measure: Perception of recovery
timeFrame: change from baseline at 4 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Ankara Yildirim Beyazıt University
name: Seyda Toprak Celenay
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03209128: Cerebral Prophylactic Irradiation With Saving Hippocampus and Amygdala
Official title: Savings of Hippocampus and Amygdala by Archetherapy in Cerebral Prophylactic Irradiation in Patients With Limited and / or Extended, Responsive or Stable Small Cell Lung Cancer (SCLC)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Non Small Cell Lung Cancer
Lead sponsor: Centre Francois Baclesse, Luxembourg
Sponsor class: OTHER
First posted: 2017-07-06
Enrollment: 11
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: Patients with limited SCLC histologically proven to be responders or stable to radiochemotherapy or patients with histologically proven extended SCLC responding to chemotherapy

Brief summary: Hippocampus and amygdala are parts of the brain involved in the recognition of emotions, memories, memory, language ... It is therefore very important to protect them during irradiation of the brain.

The aim of this study is to evaluate cerebral irradiation with saving hippocampus and amygdala protects these brain functions in patients with small cell lung cancer (SCLC) Radiotherapy of the brain


Eligibility criteria: Inclusion Criteria:

* Patients over 18 years of age
* Patients with a limited SCLC demonstrated histologically responsive or stable to radiochemotherapy or patients with a histologically proven extended SCLC responding to chemotherapy.
* WHO Performance Index 0-1 and / or Karnovsky Index\> 70
* Possibility of long-term monitoring

Exclusion Criteria:

* Concomitant chemotherapy
* Impossibility of performing an MRI or CT without injection
* Presence of cerebral metastases
* History of cerebral irradiation at any time
* Patient suffering from severe collagenosis
* Patient with cognitive disorders with MMSE score \<24

Primary outcomes:
measure: Cognitive function
timeFrame: until 18 months after inclusion of patient
Secondary outcomes:
measure: Secondary effects according the CTCAE v.4 criteria
timeFrame: until 18 months after inclusion of patient
measure: Appearance of brain metastases and their location
timeFrame: until 18 months after inclusion of patient
measure: Quality of life (QOL) of patients
timeFrame: until 18 months after inclusion of patient
Other outcomes:
Locations:
city: Esch Sur Alzette
country: Luxembourg
facility: Centre Francois Baclesse
Study officials:
References:
Clinical trial NCT05666128: Efficacy and Safety of HD-6277 in Adult Patients with Inadequate Control of Type 2 Diabetes Mellitus by Diet and Exercise
Official title: A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group, Phase 2 Study to Assess the Efficacy and Safety of HD-6277 in Adult Patients with Inadequate Control of Type 2 Diabetes Mellitus by Diet and Exercise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Hyundai Pharm
Sponsor class: INDUSTRY
First posted: 2022-12-27
Enrollment: 112
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group, Phase 2 Study to Assess the Efficacy and Safety of HD-6277 in Adult Patients With Inadequate Control of Type 2 Diabetes Mellitus by Diet and Exercise


Eligibility criteria: Inclusion Criteria:

* Diagnosis of T2DM with HbA1c between 7.0% and 10.0% (inclusive) while on diet and exercise alone for at least 6 weeks prior to screening.

Exclusion Criteria:

* Type 1 diabetes or another immune-mediated diabetes syndrome

Primary outcomes:
measure: Change in HbA1c(%) at weeks 12 from baseline
timeFrame: at weeks 12 from baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Included Severance Hospital, 10 sites
Study officials:
References:
Clinical trial NCT00029328: Etanercept for Non-Infectious Lung Injury Following Bone Marrow Transplantation
Official title: Soluble Tumor Necrosis Factor Receptor: Enbrel (Etanercept) for the Treatment of Acute Pulmonary Dysfunction (Idiopathic Pneumonia Syndrome) Following Allogeneic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Respiratory Distress Syndrome, Adult
Bronchiolitis Obliterans
Pneumonia
Keywords: TNFR-Fc fusion protein
Stem Cell Transplantation
Transplantation, Homologous
Respiratory Function Tests
Lead sponsor: FDA Office of Orphan Products Development
Sponsor class: FED
First posted: 2002-01-11
Enrollment: 15
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effects of etanercept, and define the toxicity, when administered to patients with acute non-infectious lung injury (idiopathic pneumonia syndrome, IPS) and with subacute pulmonary dysfunction after allogeneic stem cell transplantation.

Detailed description: Over the last 2 decades, allogeneic bone marrow transplantation (BMT) has emerged as an important treatment option for a number of malignant and non-malignant disorders. Unfortunately, pulmonary dysfunction remains a frequent and severe complication of allogeneic BMT. One of the main chemicals felt to cause lung damage is Tumor Necrosis Factor (TNF). Etanercept is an experimental drug that attempts to block TNF lung damage. Patients will undergo blood tests, x-rays, and a bronchoscopy with broncho-alveolar lavage prior to treatment with etanercept to check for infection. If no infection is evident after 24 hours, the etanercept will be started and administered twice weekly for 4 weeks by subcutaneous injection. There will be weekly blood tests and bronchoscopy after the last drug dose.

Eligibility criteria: Inclusion criteria:

* Diagnosis of acute idiopathic pneumonia syndrome (IPS) or sub-acute lung injury
* At least 1 year of age for IPS stratum
* At least 6 years of age for sub-acute lung injury stratum and able to perform formal pulmonary function testing
* At least 14 days since prior treatment with an investigational drug for graft-versus-host disease
* Previously treated with allogeneic stem cell or bone marrow transplantation for primary disease

Exclusion criteria:

* Documented evidence of active systemic or pulmonary infection
* Cardiogenic failure as cause of pulmonary dysfunction
* Known hypersensitivity to etanercept
* Currently receiving dialysis
* Currently receiving inotropic medications except dopamine
* Pregnant or nursing

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan, Ann Arbor, MI
name: Kenneth Cooke, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00791128: Study for Pre-Surgical Weight Loss in Type II Diabetes Patients
Official title: A Phase II Single-Center, Prospective, Open Label Study of Safety and Efficacy, of the GI Sleeve for Pre-Surgical Weight Loss, in Type II Diabetes Patients (Cohort 06-6B Only)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes
Obesity
Keywords: Type 2 Diabetes
Lead sponsor: Morphic Medical Inc.
Sponsor class: INDUSTRY
First posted: 2008-11-14
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether the GI Sleeve is safe and effective in treating Type II diabetes patients

Detailed description: Patients with obesity are at significantly greater risk of developing complications such as pulmonary dysfunction, diabetes, hypertension, and other co-morbid risks. NIH panel recommendations state that even a 10% short-weight loss would greatly reduce these risks. GI Dynamics' GI Sleeve represents a viable alternative to other short-term pre-surgical weight loss methods. GI Sleeve is a device that can be implanted and removed through minimal invasive endoscopic techniques. This endoscopic procedure brings potential benefits to patients in that it is minimally invasive, efficacious, and allows patients to recover faster with less morbidity and mortality.

Eligibility criteria: Inclusion Criteria:

* Age 18 to 65
* BMI 40 to 60
* Type II Diabetes
* Candidates for bariatric surgery

Exclusion Criteria:

Patients with

* hepatitis B or C
* gastroesophageal reflux disease (GERD)
* HIV Positive diagnosis
* pancreatitis
* conditions of gastrointestinal tract, such as ulcers or Crohn's
* an infection or who are H. Pylori positive

Primary outcomes:
measure: % of Excess Weight Loss (EWL)
timeFrame: 12 months
Secondary outcomes:
measure: HbA1c Values at 12 Months
timeFrame: 12 months
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Dr. Eduardo Guimaraes Hourneauz de Moura
state: SP
Study officials:
affiliation: Hospital das Clinicas, Sao Paulo
name: Eduardo Guimaraes Hourneaux de Moura, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: de Moura EG, Martins BC, Lopes GS, Orso IR, de Oliveira SL, Galvao Neto MP, Santo MA, Sakai P, Ramos AC, Garrido Junior AB, Mancini MC, Halpern A, Cecconello I. Metabolic improvements in obese type 2 diabetes subjects implanted for 1 year with an endoscopically deployed duodenal-jejunal bypass liner. Diabetes Technol Ther. 2012 Feb;14(2):183-9. doi: 10.1089/dia.2011.0152. Epub 2011 Sep 20.
Clinical trial NCT02964728: Botulinum Toxin in Burning Mouth Syndrome
Official title: Botulinum Toxin in Burning Mouth Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Burning Mouth Syndrome
Lead sponsor: Presidio Ospedaliero Garibaldi-Centro
Sponsor class: OTHER
Collaborators: name: Carlo Besta Neurological Institute
name: University of Catania
name: University of Padova
First posted: 2016-11-16
Enrollment: 6
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The effect of botulinum neurotoxin type A intradermal injection in will be evaluated in 4 patients with clinical diagnosis of burning mouth syndrome involving the anterior two-thirds of the tongue and the lower lip for at least 6 months, refractory to common pharmacological treatments. Pain severity will be measured by the visual analog scale (VAS) indicating average week pain before injection. Each patient will be injected with a total dose of 16 units (dilution: 2 ml saline) of incobotulinumA: 4 units into each side of the lower lip and 4 units into each antero-lateral side of the tongue. In order to determine if a placebo effect may be involved, we will inject 2 additional patients with saline solution using the same volumes and the same injection sites. Patients will be evaluated at 48 hours and then at 4, 8, 12, 16 and 20 weeks after the treatment. Patients treated with placebo will be treated after 4 weeks with incobotulinumA with the same dose reported above.


Eligibility criteria: Inclusion Criteria:

* burning mouth syndrome

Exclusion Criteria:

* any other mouth disorder

Primary outcomes:
measure: 0-100 mm Visual Analog Scale (VAS) improvement
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Lauria G, Majorana A, Borgna M, Lombardi R, Penza P, Padovani A, Sapelli P. Trigeminal small-fiber sensory neuropathy causes burning mouth syndrome. Pain. 2005 Jun;115(3):332-337. doi: 10.1016/j.pain.2005.03.028.
citation: Ranoux D, Attal N, Morain F, Bouhassira D. Botulinum toxin type A induces direct analgesic effects in chronic neuropathic pain. Ann Neurol. 2008 Sep;64(3):274-83. doi: 10.1002/ana.21427.
citation: Restivo DA, Tinazzi M, Patti F, Palmeri A, Maimone D. Botulinum toxin treatment of painful tonic spasms in multiple sclerosis. Neurology. 2003 Sep 9;61(5):719-20. doi: 10.1212/01.wnl.0000080081.74117.e4. No abstract available.
Clinical trial NCT03171428: Hepatectomy With or Without the Thoraco-abdominal Approach
Official title: Hepatectomy With or Without the Thoraco-abdominal Approach: Impact on Perioperative Outcome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery
Liver Tumors
Hepatectomy
Liver Resection
Lead sponsor: University of Milan
Sponsor class: OTHER
First posted: 2017-05-31
Enrollment: 744
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients affected by liver tumors scheduled for hepatectomy at our center.

Brief summary: The performance of hepatectomy for liver tumors using the thoraco-abdominal approach (TAA) versus the abdominal approach (AA) is still debated.

The aim of the study is the analysis of the perioperative outcome of patients operated with or without the TAA for liver tumors.

Detailed description: The prospectively maintained database was queried. A 1:1 propensity score-matched analysis was applied. Among 744 patients, 246 undergoing hepatectomy with TAA and 246 undergoing hepatectomy with AA were compared. These patients were matched for baseline characteristics, underlying liver disease, comorbidity, tumor features, and extent of the resection. The rates of morbidity and mortality were the study endpoints.

Eligibility criteria: Inclusion Criteria:

* First liver surgery;
* Any type of malignant liver tumor, including hepatocellular carcinoma on cirrhosis.

Exclusion Criteria:

* Previous history of liver surgery;
* Any type of benign liver tumor;
* Incomplete clinical, surgical, pathological or postoperative data;
* Patients treated with radiofrequency ablation alone or in combination with surgery were also excluded.

Primary outcomes:
measure: Short-term outcome: Occurrence of postoperative complications or death after surgery
timeFrame: Within 90-days after the operation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04260828: Efficacy and Safety Study of Aspirin for the Prevention of Renal Artery Stenosis in Renal Transplantation Recipients
Official title: Efficacy and Safety Study of Aspirin for the Prevention of Renal Artery Stenosis in Renal Transplantation Recipients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Renal Transplant
Lead sponsor: Henan Provincial People's Hospital
Sponsor class: OTHER
First posted: 2020-02-07
Enrollment: 368
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The anastomotic and peripheral stenosis of the transplanted kidney artery is one of the most important causes of graft failure in renal transplantation. The injury of vascular intima and the formation of microthrombosis may play a significant role in the stenosis of transplanted renal artery of recipients. Inhibiting this process with aspirin may protects against the stenosis of transplanted renal artery.

This is a prospective, randomized, controlled, clinical trial to investigate the efficacy and safety of prevention of renal artery stenosis in recipients.


Eligibility criteria: Inclusion Criteria:

1. The patients with the first renal transplantation were stable;
2. Age ≥ 18 years old;
3. Other anticoagulants and non steroidal anti-inflammatory drugs were not taken at the same time;
4. In the past 3 months, there was no acute cardiovascular and cerebrovascular disease or infection;
5. The rejection of acute and chronic renal transplantation was excluded;
6. The thrombus formation of transplanted kidney was excluded.

Exclusion Criteria:

1. Allergic or intolerable to aspirin;
2. Previous transplant history;
3. Age \< 18;
4. Take other anticoagulants or non steroidal anti-inflammatory drugs at the same time;
5. History of active gastrointestinal bleeding or severe peptic ulcer;
6. Patients with bleeding tendency or severe liver disease;
7. Cerebral hemorrhage, cerebral infarction or acute infection occurred within 3 months;
8. Acute and chronic rejection;
9. Thrombus formation of transplanted renal vessels;
10. Any condition that increases the risk of adverse events or discontinuation.

Primary outcomes:
measure: Incidence of Renal Artery Stenosis
timeFrame: 2 years
Secondary outcomes:
measure: Renal Allograft Function
timeFrame: 2 years
measure: Incidence of Graft Loss
timeFrame: 2 years
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
state: Henan
Study officials:
References: