louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01706393: Effects of Probiotics Supplementation on Intestinal Microbiome in Malignancy Pts(Get Pelvic/Abdominal Rtx)
Official title: Double Blind Placebo Controled Randomized Trial, Effects of Probiotics Supplementation on Intestinal Microbiome in Malignancy Patients Who Get Pelvic/Abdominal Radiotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer
Keywords: probiotics
intestinal microbiome
radiotherapy
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2012-10-15
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to evaluate the effect of probiotics to improve the intestinal microbiome in malignancy patients who get pelvic/abdominal radiotherapy.

Detailed description: Pelvic/abdominal radiotherapy carries a risk of complications. Acute complications include diarrhea, abdominal pain, inflammatory change in the small intestine. Radiation creates changes in bacterial microbiome, the vascular permeability of the mucosal cells and in intestinal motility. Probiotics were known to improve gastrointestinal function. This is a randomized, double-blind, placebo-controlled study involving 26 patients designed to evaluate the effect of probiotics to change the intestinal microbiome in in patients undergoing concurrent pelvic/abdominal RT.

Eligibility criteria: Inclusion Criteria:

* Patients who current diagnosis of gynecologic cancer or rectal cancer and never previously received radiation therapy and will use for the first time radiotherapy at department of radiation oncology, Seoul National University Hospital.
* ECOG performance status (PS) of 0, 1, or 2.
* signed written informed consent.
* Patients who get pelvic/abdominal radiotherapy.

Exclusion Criteria:

* People who use antibiotics that can affect intestinal microorganism growth within one month before the study.
* Patients who use probiotics within one month before the study.
* Patients received neoadjuvant chemotherapy.
* Acute enteritis symptoms (diarrhea, abdominal pain, nausea, vomiting) for the patient.
* Patients diagnosed with inflammatory bowel disease.
* Patients suspected gastrointestinal infections and other infectious diseases.
* Suspected infections from blood tests : Excessive rise in WBC, ESR, CRP
* Suspected renal insufficiency from blood tests

Primary outcomes:
measure: Changes of gut microbial communities in malignancy patients receiving pelvic/abdominal radiotherapy after probiotics administration to prevent radiation enteropathy.
timeFrame: 42 days
Secondary outcomes:
measure: Prevention of any grade of diarrhea and gastrointestinal symptoms
timeFrame: 42 days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Hak Jae Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03504293: The Diagnostic Value of Combinatory EUS and ERCP in Unclear Lesions
Official title: Sahlgrenska EUS ERCP Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neoplasms
Biliary Stricture
Biliary Tract Neoplasms
Biliary Tract Diseases
Keywords: Endosonography
Endoscopic retrograde choledochography
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2018-04-20
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with unclear lesions or strictures in the biliary tract

Brief summary: ERCP with brush cytology has a poor to moderate accuracy in unclear biliary lesions. Endoscopic ultrasound (EUS) with fine needle aspiration (FNA) for cytology may override some of these shortcomings.

The current prospective study, performed in a tertiary University center, aims to study the feasibility, the accuracy and the clinical value of combinatory ERCP and EUS in unclear biliary lesions.

Detailed description: The eligible study participants with unclear biliary lesions referred for an ERCP to the Sahlgrenska Univeristy Hospital endoscopy unit will be subjected to ERCP with/without brush cytology followed by EUS with/without FNA.

The results of ERCP and EUS will be compared to the pathology report of surgical specimens in resected patients or to clinical follow up at 12 months post-EUS in non-resected patients.

Eligibility criteria: Inclusion Criteria:

* Patients with unclear lesions or strictures in the biliary tract referred for endoscopy work up

Exclusion Criteria:

* Patients unwilling to participate
* Patients unfit for EUS and ERCP

Primary outcomes:
measure: Diagnostic accuracy
timeFrame: 12 months post-EUS
Secondary outcomes:
measure: Adverse event rate
timeFrame: 30 days post-EUS
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
Study officials:
affiliation: Sahlgrenska University Hospital, Gothenburg
name: Riadh Sadik, Ass Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00271193: A Primary Care Intervention for Weight Management
Official title: A Primary Care Intervention for Weight Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Healthy
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2005-12-30
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will test whether adding brief counseling visits with an ancillary health care provider (a nurse or nursing assistant) will induce additional weight loss, as compared with quarterly physician visits alone. All visits will take place at the site of usual patient care (i.e., the primary care clinic).


Eligibility criteria: Inclusion Criteria:

Body mass index (BMI) of 27 to 50 kg/m2 Capacity to provide informed consent Ability to find transportation to and from counseling sessions Willingness to be randomized to either program Commitment to attend all sessions and to complete study-related assessments, including blood tests and questionnaires

Exclusion Criteria:

Type I diabetes Myocardial infarction or stroke within the previous 6 months Clinically significant renal or hepatic disease (as judged by a study physician) History of cancer in the past 5 years Congestive heart failure requiring diuretics Previous weight loss surgery Endocrine conditions that may cause weight gain, including unstable thyroid disease or hypercortisolism Initiation of therapy with or dose change to any of the following medications within 6 weeks of starting the study: insulin; metformin; sulfonylurea; thiazolidinedione; HMG-CoA reductase inhibitor ("statin"); or SSRI for depression Long-term use of any of the following medications: oral or high-dose inhaled steroid; atypical antipsychotic; tricyclic antidepressant; antiepileptic; any prescription or over-the-counter drug for weight loss Systolic blood pressure \> 160 or diastolic blood pressure \> 100 Hemoglobin A1c ≥ 10 Pregnancy or lactation Clinically significant psychiatric disease, including major depression, eating disorders, or substance abuse

Primary outcomes:
measure: Weight change
timeFrame: 6 months
Secondary outcomes:
measure: Blood pressure
timeFrame: 6, and 12 months
measure: Lipids
timeFrame: 6, and 12 months
measure: Fasting glucose
timeFrame: 6, and 12 months
measure: Quality of life
timeFrame: 6, and 12 months
measure: Weight change
timeFrame: 12 months
measure: Waist circumference
timeFrame: 6 and 12 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Edward S. Cooper Internal Medicine Practice
state: Pennsylvania
city: Philadelphia
country: United States
facility: Presbyterian Medical Group
state: Pennsylvania
Study officials:
affiliation: Director, Weight and Eating Disorders Program, University of Pennsylvania
name: Thomas A Wadden, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00934193: Does Peri-Operative Gabapentin Reduce Chronic Post-Thoracotomy Pain?
Official title: Does Peri-Operative Gabapentin Reduce Chronic Post-Thoracotomy Pain?
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Post-thoracotomy Pain
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: Wichita Medical Research and Education Foundation
name: Ascension Via Christi Hospitals Wichita, Inc.
First posted: 2009-07-08
Enrollment: 0
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 of this study is to determine if gabapentin can decrease or prevent chronic post-thoracotomy pain.

Detailed description: This study is a prospective double blind randomized controlled trial evaluating the peri-operative use of gabapentin in the prevention or modulation of post-thoracotomy hyperalgesia. Treatment will consist of a 600 mg dose of gabapentin or placebo given preoperatively the night before surgery, based on a computer generated randomized assignment. The treatment group will continue to be medicated with gabapentin 300 mg twice daily for one month following surgery. Those not included in the treatment arm of the study will continue to take a placebo for the same duration. Follow-up will consist of a postoperative visit at approximately 48 hours and a one month clinical visit.

Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Undergoing non-cardiac thoracic surgeries
* Patients determined to have impaired decisional capacity with respect to the provision of informed consent or prisoners will not be included in the study.

Exclusion Criteria:

* Current gabapentin use or current treatment for neuropathic pain.
* Pregnant or considering becoming pregnant.

Primary outcomes:
measure: The primary objective of this study is to determine if gabapentin can decrease or prevent chronic post-thoracotomy pain.
timeFrame: 6 Months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Ascension Via Christi Hospitals Wichita, Inc.
name: Sinisa Malinovic, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06534593: Effects of Physical Therapy on Low Back Pain, Disc Height Index, Postural Stability, Disability, Gait and Function in Persons With Postero-lateral Disc Herniation
Official title: Effects of Physical Therapy on Low Back Pain, Disc Height Index, Postural Stability, Disability, Gait and Function in Persons With Postero-lateral Disc Herniation: The DISC-RELIEF Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Herniation, Disc
Low Back Pain
Lead sponsor: Foundation University Islamabad
Sponsor class: OTHER
First posted: 2024-08-02
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: the study will consist of 2 arms.
Primary purpose: TREATMENT

Brief summary: The current study aims to determine if physical therapy is significantly superior in improving postural stability, pain and function and disc height index in persons with discogenic low back pain, as compared to the standardized medical treatment.


Eligibility criteria: Inclusion Criteria:

* Both male and female participants
* Postero-lateral lumbar disc herniation
* Aged 18-50 years old
* Low back pain intensity less than 80/100mm on visual analogue scale or 8/10 on numeric pain rating scale
* Positive peripheralization and centralization phenomenon

Exclusion Criteria:

* Individuals with and any musculoskeletal, metabolic, or neurological disorders that may impair gait, postural stability or sensory integrity will be excluded from the study.

Primary outcomes:
measure: Back Pain
timeFrame: 2 weeks
measure: Lumbar Range of Motion
timeFrame: 2 weeks
measure: Postural Stability
timeFrame: 2 weeks
measure: Lumbar Disability
timeFrame: 2 weeks
measure: Stride length
timeFrame: 2 weeks
measure: Gait Velocity
timeFrame: 2 weeks
measure: Cadence
timeFrame: 2 weeks
measure: Disc height index
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Foundation University Islamabad
state: Federal
Study officials:
affiliation: Foundation University Islamabad
name: Muhammad Osama, PhD*
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04078893: The Effect of Recruiting Inactive Blood Donors Using Different Means
Official title: The Effect of Recruiting Inactive Blood Donors Using Different Means : on "Need" or Just Keeping Communication
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Blood Donors
Keywords: inactivated donors recruitment, on need ,communication
Lead sponsor: Guangzhou Blood Center
Sponsor class: OTHER_GOV
First posted: 2019-09-06
Enrollment: 14098
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 14098 inactive donors were randomly divided into three groups according to age, sex, blood donation frequency,time of last donation and blood donation site, one group acted as the control group, one will be recruited by telephone recruitment on "need", and one will just be called for improvement suggestions of blood donor service.


Eligibility criteria: Inclusion Criteria:

* inactive donors during 2016-2018

Exclusion Criteria:

* inactive donors during 2016-2018 but not eligible to donate

Primary outcomes:
measure: donate blood or not
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou Blood Center
state: Guangdong
Study officials:
References:
Clinical trial NCT03284593: Prognostic Factors and the Impact of Various Management of Acute Myeloid Leukemia in Real Life Condition
Official title: Prognostic Factors and the Impact of Various Management of Acute Myeloid Leukemia in Real Life Condition at Toulouse and Bordeaux University Hospital
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Acute Myeloid Leukemia
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2017-09-15
Enrollment: 199
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diagnosis of acute myeloid leukemia between 2000 and 2014 in 2 hospitals in South of France

Brief summary: The treatment of older patients with acute myeloid leukemia that is secondary to previous myelodysplastic syndrome, myeloproliferative neoplasm, or prior cytotoxic exposure remains unsatisfactory. We compared patients treated with intensive chemotherapy or azacitidine within two centres.


Eligibility criteria: Inclusion Criteria:

* patients with acute myeloid leukemia

Primary outcomes:
measure: Survival
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: University Hospital Bordeaux
city: Toulouse
country: France
facility: University Hospital Toulouse
Study officials:
affiliation: University Hospital, Toulouse
name: Christian RECHER, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02721693: Troponin T in Chronic Obstructive Pulmonary Disease (COPD) Patients After Physical Exercise
Official title: COPD, Physical Exercise and Troponin T
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Myocardial Diseases
Keywords: Troponin
Exercise
Lead sponsor: LHL Helse
Sponsor class: OTHER
First posted: 2016-03-29
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The primary purpose of the study is to investigate if physical exercise is associated with myocardial damage, expressed by elevated troponin T, in patients with COPD.

Detailed description: Patients with COPD will perform a cardiopulmonary exercise test (CPET) on treadmill until exhaustion, 8-12 minutes. Venous blood will be drawn before exercise test and 15 minutes, 3 hours and 24 hours after test for analysis of high sensitive Cardiac troponin T (hs-cTnT). The investigators will also measure arterial bloodgas, oxygen uptake, carbon dioxide consumption, ventilation, blood pressure, ECG, heart rate and ask for dyspnea-score.

Eligibility criteria: Inclusion Criteria:

* COPD
* GOLD 2-4
* BODE-index ≥ 2
* Referred by physician to a CPET

Exclusion Criteria:

* Other serious pulmonary diseases (e.g. cancer, sarcoidosis, restrictive pulmonary diseases)
* Chronic heart disease with unstable angina or myocardial infarction ≤ 3 months prior to inclusion
* Percutaneous coronary intervention (PCI)
* Hypertension that is not controlled

Primary outcomes:
measure: Troponin T concentration 3 h
timeFrame: 3 h
Secondary outcomes:
Other outcomes:
Locations:
city: Hakadal
country: Norway
facility: LHL-klinikkene
state: Akershus
Study officials:
affiliation: LHL Helse
name: Anne H Edvardsen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03349593: Prevalence of Hypovolemia and Heart Failure in Non-cardiac Surgery
Official title: Prevalence of Hypovolemia and Heart Failure in Non-cardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypovolemia
Heart Failure
Diastolic Dysfunction
Systolic Dysfunction
Venous; Return (Anomaly)
Keywords: Heart failure, diastolic dysfunction, venous return
Left ventricular filling pressures
Lead sponsor: Umeå University
Sponsor class: OTHER
First posted: 2017-11-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Electively scheduled individuals for breast cancer surgery, endocrinologic surgery (thyroid, parathyroid) and general abdominal surgery.

Brief summary: Prevalence of biventricular function of the heart and preoperative level of venous return is not known in non-cardiac non-morbid obese population.

The aim of the study is to assess the preoperative function of the heart and status of hypovolemia on the day of surgery.

Detailed description: Preoperative transthoracic echocardiography (TTE) is conducted in 100 individuals. Biventricular function (i.e. systolic and diastolic properties), left ventricular filling pressures and level of venous return are assessed by TTE.

Moreover high-sensitive troponine I and Nt-proBNP, ECG are collected. Multiple echocardiographic parameters will be studied for feasibility in terms of preoperative assessment of the heart.

Eligibility criteria: Inclusion Criteria:

* body mass index ≤ 35 kg/m2, electively scheduled for breast cancer surgery, endocrinologic surgery (thyroid, parathyroid) and general abdominal surgery.

Exclusion Criteria:

* Not signed consent.

Primary outcomes:
measure: Hypovolemia
timeFrame: One hour before surgery
measure: Heart failure
timeFrame: One hour before surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Luleå
country: Sweden
facility: Sunderby hospital
Study officials:
affiliation: Umeå University, Norrbotten county concil
name: Tomi P Myrberg, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stenberg Y, Rhodin Y, Lindberg A, Aroch R, Hultin M, Wallden J, Myrberg T. Pre-operative point-of-care assessment of left ventricular diastolic dysfunction, an observational study. BMC Anesthesiol. 2022 Apr 5;22(1):96. doi: 10.1186/s12871-022-01642-4.
Clinical trial NCT05712993: Comparative Study Between Transcoronoid and Infrazygomatic Anterior Maneuvers
Official title: Comparative Study Between Transcoronoid and Infrazygomatic Anterior Maneuvers to Localize the Maxillary Nerve Under Ultrasound Guidance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trigeminal Neuralgia
Lead sponsor: Iraqi Board of medical specialties
Sponsor class: OTHER
First posted: 2023-02-06
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: new technique in targeting V2 under ultrasound guidance

Detailed description: the classical approach of V2 transcoronoin for practitioner is considered as difficult with significant failure rate with sustained V3 motor stimulation our approach infrazygomatic anterior out of plane is considered much easier in achieving pure V2 stimulation without V3 which make the thermal radio frequency 80 Celsius can be performed safely

Eligibility criteria: Inclusion Criteria:above 40 severe pain normal neurological examination -

Exclusion Criteria:metastasis allergy to medication used radio frequency precautions previous failed radio frequency or microvascular decompression gamma knife coagulpathy sepsis or active infection at site of needle entry

-

Primary outcomes:
measure: 1-efficacy and safety of infrazygomatic anterior out of plane 2- how can infrazygomatic maneuver can help in decrease the chance of targeting V3 in addition V2 during injection
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Baghdad
country: Iraq
facility: Mohammed Mahdi
Study officials:
References:
Clinical trial NCT06916793: A Phase 3 Study to Evaluate the Safety and Efficacy of CKD-843 in Male Patients With Androgenetic Alopecia
Official title: A Randomized, Double-blind, Multi-center, Placebo-controlled, Parallel-group Phase 3 Trial to Evaluate the Efficacy and Safety of CKD-843 in Male Patients With Androgenetic Alopecia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Androgenetic Alopecia
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2025-04-08
Enrollment: 288
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multi-centers, randomized, double-blind, parallel-group, Phase 3 Trial to evaluate the efficacy and safety of CKD-843 in Male patients with Androgenetic Alopecia

Detailed description: The participants were randomly assigned to one of the following groups: CKD-843 dose #1, CKD-843 dose #2, placebo, or Dutasteride group. They received the assigned medication, placebo for blinding, or the reference drug over a 12-month period.

Eligibility criteria: Key Inclusion Criteria:

* Male of age 18-50 years
* Clinical Diagnosis of Androgenetic Alopecia
* Written informed consent

Key Exclusion Criteria:

* Other types of Alopecia or other diseases that can cause hair loss
* Clinically significant scalp disease such as seborrheic dermatitis or psoriasis
* Clinically significant hepatic disease, thyroid disease, or mental illness, as determined by the Investigator
* Participants who do not agree to use contraception during the trial and for 24 weeks after the last dose, and plan to provide sperm or conceive within 24 weeks after the last dose

Primary outcomes:
measure: Total number of hair Changes
timeFrame: Baseline, Week 24
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: OhSang Kwon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: