louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04182178: Long-term Follow-up After Surgical Treatment for GERD (Gastroesophageal Reflux Disease)
Official title: Long-term Follow-up of Patient Satisfaction, Reflux Control and Gastrointestinal Disorders in Patients Undergoing Laparoscopic Surgical Treatment for GERD, With Partial or Total Fundoplication
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patient Satisfaction
Relapse
Dysphagia
Bloating
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2019-12-02
Enrollment: 307
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Gastroesophageal Reflux Disease

Brief summary: 10 years of follow-up with SF-36 global (Quality of Life issues), GSRS (Gastrointestinal Symptom Rating Scale) and two reflux specific questionnaires.

Detailed description: Long-term follow up with questionnaires after surgery with laparoscopic 270 degrees posterial partial fundoplication vs total fundoplication for the treatment of gastroesophageal reflux disease.

Quality of Life SF-36; physical and mental component scores. GSRS, five dimensions of abdominal symptoms; reflux, abdominal pain, indigestion, obstipation and diarrhea.

Reflux specificquestionnaries on various issues of reflux disease and frequency issues about reflux disease problems.

Eligibility criteria: Inclusion Criteria:

Gastroesophageal Reflux 10 years follow-up after surgery informed consent

Exclusion Criteria:

Deceased patients patients who declined participation

Primary outcomes:
measure: SF-36 Quality of life
timeFrame: 10 years
measure: Gastrointestinal Symptom Rating Scale (GSRS)
timeFrame: 10 years after operation
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Ersta Hospital
state: Region Stockholm
Study officials:
affiliation: Karolinska Institutet
name: Anders Thorell, professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Analatos A, Hakanson BS, Ansorge C, Lindblad M, Lundell L, Thorell A. Clinical Outcomes of a Laparoscopic Total vs a 270 degrees Posterior Partial Fundoplication in Chronic Gastroesophageal Reflux Disease: A Randomized Clinical Trial. JAMA Surg. 2022 Jun 1;157(6):473-480. doi: 10.1001/jamasurg.2022.0805.
Clinical trial NCT00263978: Defibrotide Compassionate Use for Patients With Life Threatening Veno-Occlusive Disease of the Liver
Official title: Defibrotide Compassionate Use Protocol for Patients With Life Threatening Veno-Occlusive Disease of the Liver
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Liver Diseases
Keywords: Venous occlusive disease
VOD
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2005-12-12
Sex: ALL
Minimum age (years): 1
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no

Brief summary: Severe veno-occlusive disease (VOD) of the liver is a life threatening complication of blood and marrow transplantation. Treatment with currently available (Food and Drug Administration \[FDA\] approved) agents fails in most cases. Recently conducted clinical studies indicate that patients benefit from defibrotide, a non-FDA approved agent. This protocol has been developed not with a research intent, but rather to ensure that defibrotide is used by the blood and marrow transplant programs at Children's Healthcare of Atlanta and at Emory University in a safe, effective and ethical manner.

Detailed description: Severe veno-occlusive disease (VOD) of the liver is a life threatening complication of blood and marrow transplantation. Treatment with currently available (FDA approved) agents fails in most cases. Recently conducted clinical studies indicate that patients benefit from defibrotide, a non-FDA approved agent. This protocol has been developed not with a research intent, but rather to ensure that defibrotide is used by the blood and marrow transplant programs at Children's Healthcare of Atlanta and at Emory University in a safe, effective and ethical manner.

Eligibility criteria: Inclusion Criteria:

* Veno-occlusive disease of the liver

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
Study officials:
affiliation: Children's Healthcare of Atlanta
name: John Horan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00847678: Efficacy and Safety of Mycograb as Adjunctive Therapy for Cryptococcal Meningitis in Patients With AIDS
Official title: A Multicenter, Randomized Study to Assess the Efficacy and Safety of Mycograb® as Adjunctive Therapy for Cryptococcal Meningitis in Patients With AIDS
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Cryptococcal Meningitis
Keywords: Cryptococcal Meningitis
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2009-02-19
Enrollment: 38
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: This is a multicenter, randomized, efficacy and safety trial to evaluate Mycograb®. Subjects will be randomized to one of the 3 arms: 1/ Amphotericin B (0.7 mg/kg/d) plus 5-flucytosine (100 mg /kg/d); 2/ Amphotericin B plus Mycograb® (dosed 1 mg/kg via a central line or peripheral venous line twice daily for 7 consecutive days); 3/ Amphotericin B plus 5-flucytosine plus Mycograb® (dosed 1 mg/kg via a central line or peripheral venous line twice daily for 7 consecutive days). After 2 weeks, all patients will be switched to fluconazole at 400 mg/d for 8 weeks and 200 mg/d thereafter. The total duration of the study will be approximately 24 months


Eligibility criteria: Inclusion criteria:

* Male or non-pregnant female who is \> 18 years old.
* HIV-positive or unknown, with acute, either first or recurrent episode of cryptococcal meningitis.
* Currently on no treatment, or receiving treatment (\< 3 days) with either amphotericin B plus 5-flucytosine, or amphotericin B alone.
* Positive CSF culture for Cryptococcus neoforman.
* Physical signs and symptoms of meningitis, evidenced by one or more of the following: fever, headache, meningeal signs and neurologic findings.

Exclusion criteria:

* Excluded for coma, or significant other medical conditions.
* Subject has other opportunistic fungal infections that requires other systemic antifungal therapies.

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: proportion of patients (receiving Mycograb + Amphotericin B + 5-flucytosine) cured (combined clinical and microbiological response) versus placebo (Amphotericin B + 5-flucytosine) and versus Mycograb + Amphotericin B alone.
timeFrame: day 14
Secondary outcomes:
measure: Safety of Mycograb versus placebo. Safety assessment will include: physical examination, vital signs, laboratory parameters, adverse events, serious adverse events.
timeFrame: week 10
measure: Assess the cerebrospinal fluid (CSF) penetration of Mycograb
timeFrame: Days 3, 7 and 14
measure: Determine whether Mycograb + Amphotericin B is as effective as Amphotericin B plus 5-cytosine while avoiding the potential problem of 5-cytosine toxicity.
timeFrame: Day 14
Other outcomes:
Locations:
city: South Africa
country: South Africa
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT04759378: Comorbid Esophageal Disorders in IBS Patients
Official title: Comorbid Disorders of the Esophagus in Patients With Irritable Bowel Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: GERD
Non-erosive Reflux Disease
Functional Esophageal Disorders
Irritable Bowel Syndrome
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-02-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: assess the incidence of the entire spectrum of esophageal disorders and possible theories for overlap in IBS patients using different diagnostic modalities.

Detailed description: In the practice of a gastroenterologist, irritable bowel syndrome (IBS) is the most frequent functional disorder. Its prevalence in the population is 9.8%-12.8%. Its frequency in women is more than men. In some studies, it has been shown that a patient may have an overlap of symptoms of different functional diseases of the gastrointestinal tract. Different researchers have ambiguously assessed the frequency of occurrence of esophageal disorders in patients with IBS. So, based on the publications of different authors, they are found in 15-80% of cases. In a study by N. de Bortoli et al. (2016) noted the association of IBS with functional heartburn in 77% of cases, and with GERD and hypersensitive esophagus (called heartburn associated with reflux) - in 33% of cases.

Traditionally, diagnostics of a combination of functional disorders of the esophagus and intestines were based on data X-ray and endoscopic methods. However modern research has shown the importance of using in this group of patients with daily combined pH impedance measurement. Thus, many authors have noted the undoubted advantages of this method in the diagnosis of esophageal disorders. Unfortunately, works devoted to this topic, extremely few in number, and the information obtained in them is quite contradictory, which indicates the need to continue research in this direction.

Eligibility criteria: Inclusion Criteria:

* Established diagnosis of IBS (according to the Rome criteria of the III revision).
* Upper GIT symptoms in the form of heartburn (sometimes belching), a lump in the throat, and non-cardiac chest pain.

Exclusion Criteria:

* History of thoracic, esophageal, or gastric surgery.
* Presence of duodenal or gastric ulcer on upper endoscopy.
* Presence of duodenal or gastric cancer on upper endoscopy.
* Conditions that prevent the installation of a nasogastric tube (nasopharyngeal formation, severe lumen-facial trauma).
* mental disorders state and disability.
* Pregnancy and breastfeeding.

Primary outcomes:
measure: Incidence of GERD in IBS patients who have upper GIT symptoms
timeFrame: baseline
measure: Incidence of Functional esophageal disorders in IBS patient who have upper GIT symptoms.
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05700578: Evaluation of a Novel Behavior Change Intervention for Posttraumatic Stress
Official title: Evaluation of a Novel Behavior Change Intervention for Posttraumatic Stress
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PTSD
Keywords: Psychoeducation
Online Intervention
Lead sponsor: Florida State University
Sponsor class: OTHER
First posted: 2023-01-26
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants were randomly assigned to complete one of two web based interventions
Primary purpose: TREATMENT

Brief summary: Evaluation of a Novel Behavior Change Intervention for Posttraumatic Stress

Detailed description: This study compared exposure to one of two web-based treatments in self-reported improvement of posttraumatic stress disorder (PTSD) symptoms in adults with at least one lifetime traumatic event and elevated posttraumatic stress symptoms.

Eligibility criteria: Inclusion Criteria:

* English-speaking individuals
* Experience of at least one lifetime traumatic event, as measured by the Life Events Checklist
* Score of 25 or higher on the PTSD Checklist for DSM-5

Exclusion Criteria:

* Pregnant women
* Adults unable to consent
* Prisoners

Primary outcomes:
measure: PTSD Checklist for DSM-5 (PCL-5)
timeFrame: Change from baseline to 2 weeks, change from baseline to 1 month
measure: Posttraumatic Safety Behavior Questionnaire (PSBQ)
timeFrame: Change from baseline to 2 weeks, change from baseline to 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: Anxiety and Behavioral Health Clinic
state: Florida
Study officials:
affiliation: Florida State University
name: Norman B Schmidt
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04711278: Using Virtual Reality to Prevent Pre-operative Anxiety in Ambulatory Surgery Patients
Official title: Hypnosis Mask in Pre-operative Anxiety Management in Ambulatory Surgery Patients: Using Virtual Reality
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hallux Valgus
Surgery
Keywords: hallux valgus
hypnosis
pre-operative anxiety
surgery
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2021-01-15
Enrollment: 106
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 primary objective is to evaluate the impact on pre-operative anxiety management of using the virtual reality mask for surgery of hallux valgus.

Detailed description: As secondary objectives, the study aims

* to evaluate post-operative analgesic according to non-drug pre-operative hypnosis, measured by reduction in analgesic intake, and by evaluate of pain;
* to evaluate factors which permitting discharge rapidly from hospital in case of hypnosis with virtual reality.

Eligibility criteria: Inclusion Criteria:

* Patient ≥ 18 years;
* Autonomous patient living at home;
* Affiliated to a social security scheme;
* Informed consent signed by patient;
* Patient will undergo a planned ambulatory surgery for hallux valgus.

Exclusion Criteria:

* Inability to understand STAI-A questionnaire;
* Patient refusal;
* Patient underwent a bilateral surgery;
* Patient judicial decision;
* Covered by french AME health system.

Primary outcomes:
measure: Anxiety assessment at baseline
timeFrame: baseline, pre-intervention
measure: Anxiety assessment after the surgery
timeFrame: immediately after the surgery
Secondary outcomes:
measure: Analgesic taken
timeFrame: at the end of study, an average of 1 day
measure: Duration of stay
timeFrame: at the end of study, an average of 1 day
measure: Pain assessment
timeFrame: day 1
Other outcomes:
Locations:
city: Boulogne-Billancourt
country: France
facility: Department of Orthopaedics and Traumatology, Ambroise Paré hospital, APHP
Study officials:
affiliation: Department of Orthopaedics and Traumatology, Ambroise Paré hospital, APHP
name: Christophe MENIGAUX, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Orthopaedics and Traumatology, Ambroise Paré hospital, APHP
name: Marie-Hélène SANDIFORD
role: STUDY_DIRECTOR
References:
citation: Ganry L, Hersant B, Sidahmed-Mezi M, Dhonneur G, Meningaud JP. Using virtual reality to control preoperative anxiety in ambulatory surgery patients: A pilot study in maxillofacial and plastic surgery. J Stomatol Oral Maxillofac Surg. 2018 Sep;119(4):257-261. doi: 10.1016/j.jormas.2017.12.010. Epub 2018 Jan 6.
Clinical trial NCT06802978: Lipid Profile in Diabetic and Non Diabetic CKD Patients
Official title: Study of Lipid Profile in Diabetic and Non Diabetic Chronic Kidney Disease Patients in Sohag University Hospital
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Kidney Disease Patients
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2025-01-31
Enrollment: 200
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who met all the inclusion criteria were selected randomly. No distinction is made between males and females.

Brief summary: The goal of this observational study is to compare blood lipid (fat) levels in participants with chronic kidney disease (CKD) with diabetes and without diabetes and who over 20 years old.

The main question this study aims to answer is:

Does having diabetes make fat problems worse in people with chronic kidney disease (CKD), or is there no connection between them?

Researchers will compare the blood lipid (fat) levels in people with chronic kidney disease (CKD) who have diabetes and those without diabetes to see if having diabetes makes lipid problems worse in CKD patients, or if there is no connection between diabetes and changes in lipid levels.

Participants will need to fast for 10 hours before undergoing this test. This means not eating any food or drinking anything except water.

Samples will be taken and sent to laboratory immediately.


Eligibility criteria: Inclusion Criteria:

* Patients of chronic kidney disease (CKD) presenting to the Sohag University Hospital
* Patients aged above 20 years of age.
* All patients who have given consent for enrolling into the study.

Exclusion Criteria:

* Patients aged 20 years of age or below.
* Patients on lipid-lowering drugs.
* Kidney transplanted patients.

Primary outcomes:
measure: Assessment and comparison of the lipid profile between diabetic and non-diabetic chronic kidney disease patients using the colorimetric method on a fully automated biochemistry analyser.
timeFrame: February 2025 to May 2025.
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Department of Internal Medicine , Sohag University Hospital.
Study officials:
References:
Clinical trial NCT04000178: OPTIMAL STENTS DURING RENAL COLIC
Official title: COMPARISON OF SILICONE VERSUS POLYURETHANE URETERAL STENTS: A PROSPECTIVE CONTROLLED STUDY
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ureteral Stent Occlusion
Lead sponsor: St. Petersburg State Pavlov Medical University
Sponsor class: OTHER
First posted: 2019-06-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: From June 2018 to October 2018, patients from two distinct clinical centers were prospectively enrolled in the study and stratified (non-randomly) into either control group A, patients who received polyurethane stents (Rüsch, Teleflex), or experimental group B, patients who received silicone stents (Cook Medical). Each participant completed a survey one hour after stent insertion, in the middle of the stent dwelling period, and before stent removal or ureteroscopy noting body pain and overactive bladder via the visual analog scale pain (VASP) and overactive bladder (OAB) awareness tool, respectively. Additionally, the successfulness of stent placement, hematuria, number of unplanned visits, and stent encrustation rates were assessed within each group.


Eligibility criteria: Inclusion Criteria:

* Inclusion criteria included age (18 to 60 years old),
* confirmed ureteral stone
* prescribed ureteral stent placement for pain syndrome relief

Exclusion Criteria:

* an active urinary tract infection.

Primary outcomes:
measure: body pain
timeFrame: 4 weeks
measure: bladder overactivity
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Petersburg
country: Russian Federation
facility: First Pavlov Saint Petersburg University
Study officials:
References:
citation: Gadzhiev N, Gorelov D, Malkhasyan V, Akopyan G, Harchelava R, Mazurenko D, Kosmala C, Okhunov Z, Petrov S. Comparison of silicone versus polyurethane ureteral stents: a prospective controlled study. BMC Urol. 2020 Feb 3;20(1):10. doi: 10.1186/s12894-020-0577-y.
Clinical trial NCT01716078: The Effect of Brachial Plexus Nerve Block on Distal Peripheral Nerve Conduction
Official title: The Effect of Brachial Plexus Nerve Block on Distal Peripheral Nerve Conduction
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Anesthesia
Keywords: Brachial Plexus
Nerve Block
Nerve Conduction
Lead sponsor: Defense and Veterans Center for Integrative Pain Management
Sponsor class: OTHER
First posted: 2012-10-29
Enrollment: 0
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: Male and female military health care beneficiaries age 18 years and older presenting for hand surgery and eligible for a brachial plexus nerve block will be asked to participate in this study.

Brief summary: The purpose of this study is to determine the conducting ability of distal extremity nerves after a supraclavicular brachial plexus nerve block (with local anesthetic) has been placed at a more proximal location in the upper extremity.


Eligibility criteria: Inclusion Criteria:

* Male and female military health care beneficiaries 18 years and older, capable of providing informed consent indicating awareness of the investigational nature of the study, in keeping with institutional policy
* Written informed consent must be obtained from each patient prior to entering the study
* Patients must be willing to have a regional anesthetic nerve block placed prior to their scheduled procedure
* Patients must be willing to have neurodiagnostic tests performed prior to placement and after placement of the regional anesthesia nerve block

Exclusion Criteria:

* Refusal to have a brachial plexus nerve block placed
* Refusal to have serial nerve conduction studies performed
* Contraindication for a regional anesthesia nerve block (allergy to local anesthetic, infection at site of injection, elevated coagulation time)
* Presence of conditions affecting the hand or arm (e.g., injury, infection) that might preclude the performance of nerve conduction studies
* Presence of known major abnormalities of nerve conduction, e.g., absent median sensory potential in a patient scheduled for carpal tunnel release
* Presence of conditions affecting the contralateral hand or arm (e.g., injury, infection) that might preclude the performance of sensory and motor studies to test block or absence of a contralateral upper extremity

Primary outcomes:
measure: Compund Muscle Action Potential (CMAP) amplitude
timeFrame: 1 day
Secondary outcomes:
measure: Distal Latency
timeFrame: 1 day
measure: Peak Latency
timeFrame: 1 day
measure: Onset Latency
timeFrame: 1 day
Other outcomes:
Locations:
city: Fort Meade
country: United States
facility: Fort Meade
state: Maryland
Study officials:
References: