louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01302002: The Use of Metformin in Early Breast Cancer Patients Pre-Surgery
Official title: The Use of Metformin in Early Breast Cancer Patients Pre-Surgery: A Phase 0 Study Regarding The Biological Effect
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: EARLY_PHASE1
Conditions: Breast Cancer
Keywords: Breast Cancer
Metformin
Pre-Surgery
Lead sponsor: Instituto Nacional de Cancer, Brazil
Sponsor class: OTHER_GOV
First posted: 2011-02-23
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The study will test metformin in patients with early breast cancer. Blood and tissue will be collected before and after the use of metformin.

Detailed description: Patients will take metformin twice a day for 3 weeks before surgery. The hypothesis is that metformin will reduce cell proliferation rates (Ki67) and increase apoptoses (TUNEL)in tumor tissue.

The study will collect and analyze pre- and post-treatment blood specimens for:

* Serum glucose
* Insulin levels
* Estradiol
* HOMA test
* Glycosylated haemoglobin

Eligibility criteria: Inclusion Criteria:

* Invasive breast cancer T1 or T2, Nx
* Knowledge of the investigational nature of the study and ability to provide consent for study participation

Exclusion Criteria:

* Diabetes or baseline glucose or Glycosylated haemoglobin upper limit of normal for the institution
* Recent use of corticosteroids
* AST \> 1.5 times upper limit of normal for the institution
* Pregnancy
* Serious clinical illness
* Prior or concurrent systemic neoadjuvant Breast Cancer therapy.

Primary outcomes:
measure: To determine the in situ effects of metformin in women with operable stage I or II breast cancer
timeFrame: 60 days after the surgery
Secondary outcomes:
measure: To analyse gastrointestinal toxicity
timeFrame: One week , 2 weeks and 20 days after Metformim beginning
measure: To analyse the blood tests one day before the biopsy and one day before the surgery
timeFrame: 5 days after blood collection
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Hospital do Cancer III
Study officials:
affiliation: Instituto Nacional de Cancer
name: Ana Elisa Lohmann, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03311802: A Risk Scores for Predicting Prevalence of Diabetes in the LAO Population
Official title: A Risk Scores for Predicting Prevalence of Diabetes in the LAO Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Undiagnosed Diabetes
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2017-10-17
Enrollment: 1098
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: population living in the selected community nearby Vientiane city

Brief summary: This was a cross-sectional investigation conducted from December 2015 to July 2017, in 15 selected rural villages of 2 districts of Vientiane municipality, Lao PDR. Target population was interested people, both men and women of age range between 30 to 70 years, living in the selected community. Someone diagnosed with diabetes and/or using any anti-diabetic drug was excluded.

The study protocol initiated with the interview on demographic and behavior information with each participant, followed by physical exam and blood pressure measurement.

Fasting glucose were measured.

Detailed description: All participants were invited to meet with the researcher.

Demographic data comprises of age, gender, family history of diabetes including parents and sibling, female with history of having baby weighing more than 4 kg, gestational diabetes, and history or current of dyslipidemia (triglycerides \>150 mg/dl, LDL-C ≥ 100 mg/dl, HDL-c \< 35 mg/dl), and behavior data were smoking habit, physical inactivity (less than 150 min/week or 3 day/week) were collected by interview.

After that each participant was appointed for blood pressure measurement. Body mass index was computed from body weight (kg) divided by body height (m2) using the weight and height scale.

Waist Circumference was measured at the midpoint between the superior border of iliac crest and the lowest rib using measuring tape with the subject in the position of standing relax and in underclothes

Hip circumference is measured at the level of maximal gluteal protrusion

Blood pressure (BP) value was done with the participants, after 5 minutes relaxing, sitting up right with their upper arm positioned at heart level and measured by Omron blood pressure monitor.

Fasting Plasma Glucose was utilized to identify an individual who is normal, has either pre-diabetes or undiagnosed diabetes. Venous blood samples were collected 5 ml from antecubital vein into the test tube

Eligibility criteria: Inclusion Criteria:

* of age range between 30 to 70 years, living in the selected community.

Exclusion Criteria:

* diagnosed with diabetes and/or using any anti-diabetic drug

Primary outcomes:
measure: fasting plasma glucose
timeFrame: 06.00-09.00 am
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03653702: Radiation-Free Technique for Evaluating Renal Scarring (RAFTERS)
Official title: Radiation-Free Technique for Evaluating Renal Scarring (RAFTERS)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Vesico-Ureteral Reflux
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2018-08-31
Enrollment: 70
Sex: ALL
Minimum age (years): 6
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: In this research study the investigators want to study a safe, radiation-free technique known as contrast-enhanced ultrasound that may improve the ability to diagnose or evaluate renal scarring compared to regular ultrasound. This technique requires injection into a vein of a small amount of contrast material called Lumason. Contrast material is a type of dye that helps the investigators image the structures in the body more clearly. If this technique is successful, the need for DMSA studies may be avoided to diagnose or evaluate kidney scarring. DMSA is a more expensive test, causes radiation exposure, may require sedation and/or injection of contrast agents with the potential to cause allergic reactions.


Eligibility criteria: Inclusion Criteria:

* patients older than or equal to 6 months and less than or equal to 35 years old and scheduled for Boston Children's Hospital (BCH) DMSA scan to evaluate renal function and/or renal scarring

Exclusion Criteria:

* patients with significant congenital renal anatomical abnormalities including horseshoe kidney, kidney malrotation, and multicystic dysplastic kidney (MCDK). Patients with severe cardio-pulmonary diseases will also be excluded.

Primary outcomes:
measure: Performance of CEUS result and comparison to DMSA
timeFrame: 3 months after final participant completes participation
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
References:
Clinical trial NCT05680402: Effects of Soft Tissue Mobilization Technique and Piriformis Muscle Stretching Among Patients Having Piriformis Syndrome
Official title: Effects of Soft Tissue Mobilization Technique and Piriformis Muscle Stretching Among Patients Having Piriformis Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Piriformis Syndrome
Lead sponsor: Neuro Counsel Hospital, Pakistan
Sponsor class: OTHER
Collaborators: name: Physiotherapy Clinic Iqra University Islamabad (Chak Shahzad)
name: Noor Hospital Tarnol, Islamabad
First posted: 2023-01-11
Enrollment: 30
Sex: ALL
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Control Clinical Trial in which group 1 will be of experimental group and group 2 will be of control group
Primary purpose: OTHER

Brief summary: It is a randomized control trail in which soft tissue mobilization and piriformis stretching will be compared and study duration will be of five months

Detailed description: Piriformis syndrome is one of the misdiagnosed syndromes and there is no evidence available for the proper diagnosis of this syndrome. Several interventions have been adopted in the clinical setting for improvement of piriformis syndrome including therapeutic ultrasound, myofascial release, stretching, dry needling, strengthening exercises of hip muscles and activity modification. There are several treatments available for this syndrome but no comparison studies have been reported yet on soft tissue mobilization and piriformis muscle stretching. The purpose for conducting this research is to assist in establishing the effectiveness of soft tissue mobilization technique and piriformis muscle stretching in piriformis syndrome by comparison between two abovementioned treatments

Eligibility criteria: Inclusion Criteria:

* Males and females with age between 25 and 45 years
* Patients with positive piriformis test
* Pain at least 3 according to numeric pain rating scale (NPRS)

Exclusion Criteria:

* History of hip pain due to any diagnosed hip pathology
* Leg length discrepancy
* Past history of spinal surgery
* Spinal tuberculosis
* Rheumatoid disease,

Primary outcomes:
measure: Numeric Pain Rating Scale
timeFrame: 1 week
measure: Modified Oswestry Disability Index (ODI) questionnaire
timeFrame: 1 Week
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Physiotherapy Clinic Iqra University Islamabad (Chak Shahzad)
state: Federal
Study officials:
affiliation: Al Nafees medical College Hospital
name: Muhammad Kamran, M.Phil*
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05001802: Comparison of Two Techniques of Quadratus Lumborum Block
Official title: Transverse Versus Longitudinal Technique of Ultrasound-Guided Transmuscular Quadratus Lumborum Block:A Randomized Controlled Study Comparing Dermatomal Spread
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nerve Block
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2021-08-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Our objective is to investigate the extent of cranial dermatomal spread of transmuscular quadratus lumborum block(TMQLB )when equal dosage(ml/kg) of local anesthetic are injected with the transverse versus an modified paramedian sagittal approach for patients undergoing laparoscopic adrenalectomy.

Detailed description: The paramedian sagittal oblique transmuscular quadratus lumborum block(TMQLB )approach has been introduced to facilitate cranial spread by injecting the local in a caudal to cranial direction compared with the transverse approach. Currently, there are no data comparing the two techniques mentioned above with regards to extent of spread level. Our objective is to investigate the extent of cranial dermatomal spread of TMQLB when equal dosage(ml/kg) of local anesthetic are injected with the transverse versus an modified paramedian sagittal approach for patients undergoing laparoscopic adrenalectomy. In addition, the investigators wish to compare the performance time, caudal dermatomal spread of TMQLB and postoperative analgesia effect.

Eligibility criteria: Inclusion Criteria:

* ≥Age 18yrs

  * American Society of Anesthesiologists physical status I-II
  * Undergo laparoscopic adrenalectomy
  * Informed consent
  * Able to cooperate with study process

Exclusion Criteria:

* Allergy to local anesthetic and other medications used in the study
* Patient refusal or lack of informed consent
* Coexisting hematological disorder or with deranged coagulation parameters
* Pre-existing major organ dysfunction such as hepatic and renal failure
* History of previous renal surgery.

Primary outcomes:
measure: Cephalic sensory dermatomal spread
timeFrame: 20 minutes after block performance]
Secondary outcomes:
measure: Time to performance of procedure
timeFrame: Duration of procedure
measure: Total sensory dermatomal spread
timeFrame: 20 minutes after block performance
measure: Incidence of complication
timeFrame: Within 48 hours after surgery
measure: Caudal sensory dermatomal spread
timeFrame: 20 minutes after block performance
measure: rescue analgesics usage
timeFrame: At 0,12,24,48 hours after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
city: Beijing
country: China
facility: Peking Union Medical College Hospital
Study officials:
References:
Clinical trial NCT04211402: A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Obsessive-Compulsive Disorder
Official title: A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Obsessive-Compulsive Disorder (OCD)
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Obsessive-Compulsive Disorder
Lead sponsor: ProgenaBiome
Sponsor class: OTHER
First posted: 2019-12-26
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with OCD

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

Detailed description: The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to infection with Obsessive-Compulsive Disorder.

Eligibility criteria: Inclusion Criteria:

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

   a. May be signed by parent or legal guardian in the case of minor or adult unable to provide consent
2. Male or female of all ages
3. OCI greater than or equal to 21

Exclusion Criteria:

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

Primary outcomes:
measure: Correlation of Microbiome to Disease via Relative Abundance Found in Microbiome Sequencing
timeFrame: Three years
Secondary outcomes:
Other outcomes:
Locations:
city: Ventura
country: United States
facility: ProgenaBiome
state: California
Study officials:
affiliation: ProgenaBiome
name: Sabine Hazan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00436202: Evaluation of an Intervention Program for the Prevention of Anemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anemia
Keywords: Anemia
Iron
Supplement
Lead sponsor: Wolfson Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Tel Aviv District of the Health Office
First posted: 2007-02-16
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to determine whether improvement in the accessibility to iron supplement will decrease anemia rates in infants.

Detailed description: Iron deficiency anemia is the most common type of anemia in infants, children and women of reproductive age. The most frequent cause of iron deficiency in infants at 6 months of life is poor nutrition during a period of rapid growth and a diet lacking in iron rich foods. Children who suffered from anemia in infancy demonstrated slower cognitive development, were low achievers in school and had a high rate of behavioral disturbances.

The Ministry of Health implements a primary prevention program for anemia. If by making iron supplements more accessible would increase parental compliance in acquisition of the iron supplement and subsequently reduce the rate of iron deficiency anemia, the result would be the immediate application of the finding. It is possible to implement a program whereby the supplement will be directly available at the family health centers for purchase by the parent.

Eligibility criteria: Inclusion Criteria:

* Infant who visit Family Health Centers

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Tel Aviv District of the Health Office
Study officials:
affiliation: Tel Aviv District of the Health Office
name: Tamar Shohat, M.D., MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06604702: Fat Injection for Rectocele Treatment: A Novel Approach
Official title: Fat Injection for Treatment of Rectocele a Novel Technique for Treatment of Tectocele
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Rectocele
Pelvic Organ Prolapse
Obstructive Defecation Syndrome
Keywords: Rectocele
Pelvic Floor Dysfunction
Fat Grafting
Autologous Fat Injection
Obstructive Defecation
Pelvic Organ Prolapse
Vaginal Bulge
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single-arm prospective interventional trial where all participants undergo submucosal fat injections for the treatment of rectocele.
Primary purpose: TREATMENT

Brief summary: This clinical trial aims to evaluate the effectiveness of autologous fat grafting as a novel treatment for rectocele, a condition characterized by the herniation of rectal tissue into the posterior vaginal wall. Women aged 18 to 60 years with mild to moderate rectocele, presenting with symptoms such as obstructive defecation or vaginal bulge, will undergo submucosal fat injections. The study will assess the procedure\&#39;s ability to alleviate symptoms and reduce prolapse recurrence. This prospective, single-arm trial will be conducted at Cairo University Hospitals.


Eligibility criteria: Inclusion Criteria:

* Female patients aged between 18 and 60 years.
* Diagnosis of rectocele confirmed by defecography, with a rectocele size of 2 cm (mild) to 4 cm (moderate).
* Presenting with symptoms of obstructive defecation syndrome, including constipation, incomplete defecation, and/or vaginal bulge.
* Able to provide written informed consent to participate in the study.

Exclusion Criteria:

* Patients who have previously undergone surgical repair of rectocele.
* Presence of thrombosed hemorrhoids.
* History of sclerotherapy injection for rectocele.
* Diagnosis of anal stenosis.
* History of coagulopathy or current use of anticoagulant or antiplatelet medications.
* Refusal or inability to provide informed consent.

Primary outcomes:
measure: Reduction in Rectocele Size
timeFrame: 6 months post-procedure
measure: Symptom Relief
timeFrame: 6 months post-procedure
Secondary outcomes:
measure: Rate of Recurrence of Rectocele
timeFrame: 6 months post-procedure
measure: Postoperative Pain
timeFrame: Up to 1 week post-procedure
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00849602: The Effect of Chloroquine in the Treatment of Patients With Dengue
Official title: The Effect of Chloroquine in the Treatment of Patients With Dengue
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Dengue
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2009-02-24
Enrollment: 132
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: The objective of this study was to evaluate the effect of chloroquine in the treatment of patients with dengue.


Eligibility criteria: Inclusion Criteria:

* Patients suspected of having dengue disease
* Patients were included in the study if they presented with fever and at least two other symptoms, such as:

  * headache
  * pain behind the eyes
  * muscle and bone or joint pains
  * nausea
  * vomiting
  * rash associated to dengue for less than 72 hours

Exclusion Criteria:

* Pregnant
* Younger than 18-years old
* Either cardiac or neurologic disease

Primary outcomes:
measure: Duration of the disease
timeFrame: one week
Secondary outcomes:
measure: Intensity and days of fever and symptoms
timeFrame: one week
Other outcomes:
Locations:
city: Ribeirão Preto
country: Brazil
facility: São Paulo University Medical School at Ribeirão Preto
state: SP
Study officials:
affiliation: São Paulo University Medical School at Ribeirão Preto
name: Benedito AL Fonseca, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02940002: BAY1003803 Formulation Comparison in Open Psoriasis Plaque Test
Official title: A 28-day, Double-blind, Randomized, Reference-controlled Psoriasis Plaque Test to Evaluate the Efficacy and Safety of Two Different BAY1003803 Formulation Types in 2 Concentrations Each in Treatment of Symptomatic Volunteers With Plaque-type Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Psoriasis
Keywords: Plaque form psoriasis vulgaris
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-10-20
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: To explore the efficacy and safety of four BAY1003803 formulations by means of a within subject comparison in an open Psoriasis Plaque Test


Eligibility criteria: Inclusion Criteria:

* Male and female (non-childbearing potential) volunteer with stable plaque-type psoriasis, but otherwise healthy
* Age: 18-64 years

Exclusion Criteria:

* Severe disease within the last 4 weeks prior to the first study drug administration as determined by the investigator
* Any topical antipsoriatics on plaques potentially to be treated in this trial (including corticosteroids, vitamin D analogues, immunomodulators, retinoids, dithranol and tar, except for salicylic acid (Pretreatment) in the 4 weeks before first treatment and/or planned during the trial, except for allowed topical treatment on the face, ears and scalp
* Systemic treatment depending on kind of treatment within 4 weeks and 6 months prior and/or planned during the trial
* Treatment with concomitant medication that may affect and provoke or aggravate psoriasis, e.g. antimalarial drugs, lithium, beta-blockers or angiotensin-converting-enzyme inhibitors (AEC inhibitors) unless on a stable dose for 3 months before study medication initiation
* Clinico-chemical parameters of clinically significant deviation

Primary outcomes:
measure: Change in infiltrate thickness from day 1 to day 29 measured by sonography using 22 MHz B mode ultrasound
timeFrame: Day 1 to 29
Secondary outcomes:
Other outcomes:
Locations:
city: Schwerin
country: Germany
state: Mecklenburg-Vorpommern
city: Bochum
country: Germany
state: Nordrhein-Westfalen
city: Hamburg
country: Germany
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: