louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05878548: Management of Combined Fracture Neck of Femur and Femoral Deformity in Osteogenesis Imperfecta Patient
Official title: Management of Combined Fracture Neck of Femur and Femoral Deformity in Osteogenesis Imperfecta Patient
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Osteogenesis Imperfecta
Keywords: Osteogenesis imperfecta
fracture neck of femur
telescoping nail
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-05-26
Enrollment: 1
Sex: ALL
Minimum age (years): 2
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: fixation with Wagner technique
Primary purpose: TREATMENT

Brief summary: O.I with NOF fixed by Wagner technique and telescoping nail

Detailed description: osteogenesis imperfecta (Sillence Type IV) sustained neck of femur fracture after fall on ground. He had proximal femoral anterolateral bowing on top of inserted rod 4 years ago. He was treated with corrective osteotomy and intramedullary telescoping nail for deformed femur and Wagner technique to fix NOF fracture. One year after operation the patient gained satisfactory functional outcome with union of NOF fracture and correction of femoral deformity. This rare case illustrates the anticipated difficulties in managing neck of femur fracture in osteogenesis imperfect patients. The method of fixation with Wagner technique can achieve stable fixation for solid healing in fragility fractures like this and the least interference with telescoping nail insertion.

Eligibility criteria: Inclusion Criteria:

* OI

Exclusion Criteria:

* Not receiving Bisphosphonate

Primary outcomes:
measure: modified McKay's criteria
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: faculty of medicine Assiut university
Study officials:
affiliation: Assiut University
name: Hesaham M Elbaseet, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hidalgo Perea S, Green DW. Osteogenesis imperfecta: treatment and surgical management. Curr Opin Pediatr. 2021 Feb 1;33(1):74-78. doi: 10.1097/MOP.0000000000000968.
citation: Fralinger DJ, Kraft DB, Rogers KJ, Thacker MM, Kruse RW, Franzone JM. The Fate of the Bent Rod in Children With Osteogenesis Imperfecta. J Pediatr Orthop. 2023 Jul 1;43(6):e465-e470. doi: 10.1097/BPO.0000000000002409. Epub 2023 Apr 6.
Clinical trial NCT05835648: Effect of Dietary Fiber on Non-dialysis Patients With Chronic Kidney Disease
Official title: Effect of Dietary Fiber on Anemia and Glomerular Filtration Rate in Non-dialysis Patients With Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Kidney Disease
Keywords: Dietary fiber
CKD
Anemia
glomerular filtration rate
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2023-04-28
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The main objective of this study was to investigate the effect of dietary fiber on anemia and glomerular filtration rate in non-dialysis patients with chronic kidney disease. Participants will be randomly divided into a dietary fiber intervention group and a blank control group. The patients in the dietary fiber intervention group will have dietary fiber intake survey conducted by dietitians on the basis of basic treatment. Supplemented dietary fiber was given on the basis of daily diet, once a day, 1 piece each time, before meals, and the intervention lasted for 3 months. The blank control group was followed up without intervention. Clinical data, blood, urine and stool samples were collected at the initial diagnosis and at each follow-up site.


Eligibility criteria: Inclusion Criteria:

* Above 18 years old;
* Clinically confirmed (history, blood creatinine, kidney B-ultrasound, laboratory examination, etc.) as stage 3-5 chronic kidney disease, endogenous creatinine clearance was \< 60ml/min according to Cockcroft-Gault formula;
* Generally in good condition, have a good understanding of their own illness and physical condition, have self-awareness, and can communicate well with others;
* Hemoglobin 100-130g/L;
* In a non-dialysis state.
* Dietary fiber intake \<25g/d;
* Voluntarily join the study, understand the significance of the test and the indicators to be measured, and sign the informed consent.

Exclusion Criteria:

* Unwilling to join the study; Severe infection: fever, cough and sputum, pharyngeal pain, abdominal pain, diarrhea, carbuncle and other skin and soft tissue infection and other clinical manifestations, blood routine white blood cell count beyond the normal range (10×109/L);
* Severe cardiovascular diseases: including chronic cardiac insufficiency grade 3 or above and various arrhythmias;
* Obvious hypoproteinemia: albumin less than 30g/L;
* Corrective measures for anemia (blood transfusion, erythropoietin, HIF-PHI, iron supplement) have been applied in the past 3 months;
* Tumor evidence: certain tumors have been detected or clinical manifestations and tumor markers suggest the possibility of tumor;
* Pregnant women;
* Recent history of heavy blood loss.

Primary outcomes:
measure: Changes in baseline hemoglobin levels at 9 months
timeFrame: 9 months
measure: Changes of glomerular filtration rate at baseline at 9 months
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00439348: Over-the-Counter Medication Usage
Official title: Improving Over-the-counter Medication Compliance.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Drugs, Non-Prescription
Medication Systems
Keywords: Calcium
Compliance
Medication compliance
electronic prescription
over-the-counter medications
OTC medications
Lead sponsor: AdventHealth
Sponsor class: OTHER
First posted: 2007-02-23
Enrollment: 246
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: There are several benefits of over-the-counter medications, yet there is little research evaluating how to increase patient compliance when a health care provider suggests an over-the-counter (OTC) medication. We are evaluating two types of physician directions to see which increases patient compliance with OTC medications.

Detailed description: Researchers will identify a cohort of gynecologic patients presenting for annual examinations and offer participation in the study. Physician researchers will randomize patients to 2 types of physician directions about OTC medications, then follow compliance over the course of the next 7 months. A total of 123 participants in each arm will undergo recruitment, until a total of 246 participants are recruited.

Inclusion criteria include: female, non-pregnant patients presenting for annual gynecologic examinations between the ages of 19-50.

Exclusion criteria include: outside of study age range, patient taking thyroid medication, history of kidney stones, history of hypercalcemia, non-English speaking.

Eligibility criteria: Inclusion Criteria:

* Female patients undergoing annual gynecologic examinations.
* Ages 19-50.
* Patients not currently taking certain OTC medications.

Exclusion Criteria:

* Pregnancy.
* History of hypercalcemia.
* History of kidney stones.
* Outside study age range of 19-50.
* Patient taking thyroid medication.

Primary outcomes:
measure: Determining which of 2 types of physician direction regarding OTC medication usage improves patients compliance, as assessed at 3 and 6 months after enrollment.
timeFrame: 3 and 6 months after enrollment.
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Loch Haven Ob/Gyn Group
state: Florida
Study officials:
affiliation: Department of Obstetrics and Gynecology, Florida Hospital Family Medicine Residency Program
name: D. A Hill, MD
role: STUDY_CHAIR
References:
Clinical trial NCT06345248: Laparoscopic-assisted Versus Ultrasonography-guided Transversus Abdominis Plane Block in Laparoscopic Sleeve Gastrectomy
Official title: Laparoscopic-assisted Versus Ultrasonography-guided Transversus Abdominis Plane Block in Laparoscopic Sleeve Gastrectomy
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Transversus Abdominis Plane
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-04-03
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The transversus abdominis plane (TAP) block, whereby local anesthetic is injected between the internal oblique and transversus abdominis fascia to facilitate blockade of somatic afferents nerves, is an effective, non-narcotic adjunct incorporated into many ERAS protocols. We hypothesized that surgeon delivered LAP-TAPs would be non-inferior to anesthesia-delivered US-TAPs in terms of post-operative pain control


Eligibility criteria: Inclusion Criteria:

Elective laparoscopic sleeve gastrectomy aging \> 18years BMI \> 40 kg/m2, ASA score I-III

Exclusion Criteria:

history of chronic opioid consumption suffering from contraindications to regional blocks suffering from allergy to study drugs, history of prior complex abdominal wall reconstruction

Primary outcomes:
measure: morphine needed
timeFrame: UP TO 24 HOURE
Secondary outcomes:
measure: first analgesic request time
timeFrame: up to 24 hours
measure: patients' satisfaction
timeFrame: UP TO 24 HOURE
measure: opioid-associated side effects
timeFrame: UP TO 24 HOURE
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo university
Study officials:
References:
Clinical trial NCT03944330: A Study on Nutrition Support Therapy of Patients With Liver Failure
Official title: A Clinic Trail on Nutrition Support Therapy of Patients With Liver Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nutrition
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2019-05-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study is a Clinical trial to assess the efficacy of nutrition support therapy of patients with liver failure. Patients were randomized to one of 2 groups to receive different nutrition and energy support treatment.

Detailed description: Patients with liver failure (defined by APASL) induced by any precipitating factors were randomized to two groups; a treatment group and a control group. Participants in treatment group were provided with a standard hospital diet that provided 25-30 kcal/kg/day . Patients in control group receive diet guide

Eligibility criteria: Inclusion Criteria:

1. Male and female patients from 18 to 65 years of age;
2. Patient inclusion criteria: jaundice (serum total bilirubin ≥5 mg/dl) and coagulopathy (INR ≥ 1.5 or prothrombin activity ≥ 40 %), accompanied by ascites and/or encephalopathy within 4 weeks.

Exclusion Criteria:

1. Surgery with in 4 weeks
2. three degree hepatoencephalopathy
3. malignant tumors
4. cardiac failure or respiratory failure
5. liver transplantation within observing period -

Primary outcomes:
measure: Mortality at 30 day
timeFrame: 4 weeks
Secondary outcomes:
measure: liver transplant-free survival
timeFrame: 3month
measure: Laboratory variables on serum biochemistry markers
timeFrame: 3month
measure: Laboratory variables on fasting blood sugar
timeFrame: 3month
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00919230: Randomised Trial Comparing Iron Supplementation Versus Placebo in the Treatment of Anaemia After Hip Fracture
Official title: Randomised Trial Comparing Iron Supplementation Versus Placebo in the Treatment of Anaemia After Hip Fracture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hip Fracture
Keywords: Hip fracture
iron therapy
anaemia
Lead sponsor: Peterborough and Stamford Hospitals NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Peterborough Hospitals Hip Fracture Project
First posted: 2009-06-12
Enrollment: 300
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: At present our current practice is to provide a course of oral iron therapy for those patients with a post-operative haemoglobin which is below normal, but not severe enough to require a blood transfusion. Such a practice is not without side effects from the iron tablets, namely ingestion, nausea, diarrhoea, constipation. There is little evidence in the literature to support the current practice of using iron, with only one small randomised trial suggesting such therapy is unnecessary. We propose to recruit 300 patients recovering from a hip fracture with a post-operative haemoglobin below 11g/l. For those patients willing to enter the study, half will be given oral iron therapy (ferrous sulphate 200mg twice daily) for one month. The haemoglobin will be checked when the patients attends the hip fracture clinic at 6 weeks after discharge.


Eligibility criteria: Inclusion Criteria:

* patients with anaemia after surgery for a hip fracture

Exclusion Criteria:

* absence of anaemia, inability to provide consent

Primary outcomes:
measure: 6 week hemoglobin
timeFrame: 6 weeks after surgery
Secondary outcomes:
measure: Length of hospital stay side effects of therapy mortality
timeFrame: one year
Other outcomes:
Locations:
city: Peterborough
country: United Kingdom
facility: Peterborough city hospital
state: Cambs
Study officials:
affiliation: Peterborough Hospitals
name: Martyn Parker
role: PRINCIPAL_INVESTIGATOR
References:
citation: Parker MJ. Iron supplementation for anemia after hip fracture surgery: a randomized trial of 300 patients. J Bone Joint Surg Am. 2010 Feb;92(2):265-9. doi: 10.2106/JBJS.I.00883.
Clinical trial NCT03563430: Effects of Different Recovery Methods on Lactic Acid Removal, Flexibility, Strength, and Endurance
Official title: Comparison of Acute Effects on Lactic Acid Removal, Flexibility, Strength, and Endurance of Different Recovery Methods
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Recovery Methods
Exercise Training
Keywords: foam roller
electrical stimulation
low intensity aerobic training
lactate removal
Lead sponsor: Biruni University
Sponsor class: OTHER
First posted: 2018-06-20
Enrollment: 45
Sex: ALL
Minimum age (years): 20
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: neuromuscular electrical stimulation, low intensity aerobic exercise, self massage with foam roller methods
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this study is to compare these three different recovery methods following a single bout high-intensity interval exercise program with each other in terms of blood lactate clearance, muscle flexibility, muscle strength and endurance.

Detailed description: It is very important to choose the most effective recovery method for the athletes in training for their next training/competition. The recovery period is very significant in terms of removal of blood lactate and body dynamics as soon as they return to their original state and achieve high performance. Neither neuromuscular electrical stimulation, low-intensity aerobic exercise, self-massage with foam roller methods, which have been proven their effectiveness in the literature, have been compared with each other.

Eligibility criteria: Inclusion Criteria:

Young, healthy adults aged 20-25 years.

Exclusion Criteria:

* Clinical diagnosis of a cardiovascular disease.
* Clinical diagnosis of a metabolic disorder, orthopedic or neurological disease that would interfere with an exercise program,
* Clinical diagnosis of hemophili,
* Clinical diagnosis of thrombophlebitis or deep vein trombosis,
* Clinical diagnosis of peripheral arterial disease,
* Clinical diagnosis of venous insufficiency,
* Clinical diagnosis of anemia,
* Pregnancy.

Primary outcomes:
measure: Blood Lactate change
timeFrame: change from baseline and 20. minutes of recovery
Secondary outcomes:
measure: Quadriceps and Hamstring Muscle Strength
timeFrame: baseline and 1. hour
measure: Squat Endurance Test
timeFrame: baseline and 1. hour
measure: sit and reach test
timeFrame: baseline and 1. hour
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Biruni University
Study officials:
affiliation: Biruni University
name: Buket AKINCI, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00539630: TAX + Cisplatin + 5 F/U vs Cisplatin + 5 F/U in SCCHN
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Carcinoma, Squamous Cell
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-10-04
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To describe the clinical response rate in two groups (Docetaxel plus cisplatin plus 5-FU, versus Cisplatin plus 5-FU) after 3 cycle of neoadjuvant chemotherapy.


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically proven squamous cell carcinoma of the head and neck with locally advanced inoperable disease.
* Primary tumor sites eligible: oral cavity, oropharynx, hypopharynx , larynx or nasopharynx.
* Patients are required to have at least one (bi-or uni-dimensionally) measurable lesion.
* WHO performance status 0 or 1.
* Adequate bone marrow, hepatic and renal functions.

Exclusion Criteria:

* Pregnant and lactating women
* Previous chemotherapy
* Previous radiotherapy for H\&N
* Previous surgery for H\&N

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Clinical response will be evaluated by modified WHO criteria. Clinical and radiological assessment of all lesions will be performed
timeFrame: After 2 cycle, 3 cycle and after concurrent chemo/radiotherapy.
Secondary outcomes:
measure: Pathologic response if clinical response of primary tumor is CR at the end of chemotherapy and end of concurrent chemo/ radiotherapy, biopsy of primary tumor site will be performed to evaluate pathologic response rate.
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Sanofi-Aventis
Study officials:
affiliation: Sanofi
name: Hyang Rim Kim
role: STUDY_DIRECTOR
References:
Clinical trial NCT00371930: Photodynamic Therapy for Permanent Hair Removal
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Hypertrichosis
Hirsutism
Lead sponsor: University of Jena
Sponsor class: OTHER
First posted: 2006-09-04
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: 24 test persons are treated with a dye suspension followed by a laser intervention. A decrease of hair density is expected.


Eligibility criteria: Inclusion Criteria:

* age 18-60

Exclusion Criteria:

* anormal behavior
* pregnancy
* pathologic skin conditions
* medication that my interfere with the study
* allergy against the photosensitizer
* lack of compliance
* other reasons considered important by the investigator

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Jena
country: Germany
facility: FSU Jena, Dept. of Dermatology
state: Thuringia
Study officials:
affiliation: FSU Jena
name: Martin Kaatz, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01670630: A Comparison of a Sheathed to a Standard Speculum for Visualization of the Cervix
Official title: A Comparison of a Novel Sheathed Speculum to a Standard Speculum for Visualization of the Cervix
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Comparison of a Sheathed Versus Standard Plastic Speculum
Keywords: speculum
vagina
cervix
examination
Lead sponsor: AdventHealth
Sponsor class: OTHER
Collaborators: name: MDI Worldwide LLC
First posted: 2012-08-22
Enrollment: 136
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to estimate if a novel sheathed speculum provides improved visualization of the cervix compared to a standard ("non sheathed") speculum, and to estimate if the sheathed speculum causes less discomfort during the examination.

Detailed description: This is a randomized trial where physician investigators will perform clinically indicated vaginal speculum examinations using either a sheathed or a standard plastic speculum, to determine which speculum provides the best visualization of the cervix. As a secondary outcome, study participants will record their pain level on a 10-cm visual analogue scale.

Eligibility criteria: Inclusion Criteria:

* Undergoing clinically indicated vaginal speculum examination.
* Subject has had at least 1 prior vaginal deliver \> 20 weeks gestational age.
* Able to read and speak English.

Exclusion Criteria:

* Active vulvar lesions or conditions (sexually transmitted infections, vestibulodynia, candida, vaginitis, or vulvar dermatologic condition).
* Menopausal or using hormone replacement therapy.
* Genital atrophy.
* Chronic pelvic pain, dyspareunia, or interstitial cystitis.

Primary outcomes:
measure: Degree of cervix visualized.
timeFrame: During vaginal speculum examination.
Secondary outcomes:
measure: Comparison of pain during speculum examination.
timeFrame: During speculum examination.
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Loch Haven Ob/Gyn Group
state: Florida
Study officials:
affiliation: AdventHealth
name: David A Hill, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hill DA, Cacciatore ML, Lamvu G. Sheathed versus standard speculum for visualization of the cervix. Int J Gynaecol Obstet. 2014 May;125(2):116-20. doi: 10.1016/j.ijgo.2013.10.025. Epub 2014 Feb 1.