louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03390153: Reduction of Shear Forces Using Semi-flexible Sockets on Transtibial Amputees
Official title: Reduction of Shear Forces Using Semi-flexible Sockets on Transtibial Amputees
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amputation
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2018-01-04
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of this graduate student research study, is to test two different sockets for comfort and test what pressures are created by the socket during daily activities. The objective is to illustrate that semi-flexible sockets will maintain its rigidity and resist progressive shear forces from daily activity, ergo making our prosthetic system a more comfortable experience for the prosthetic user.

Detailed description: Subjects will immediately be prepared for a casting of their residual limb. On the second visit, subjects will return to be fitted with a definitive rigid carbon fiber socket. At this time, a questionnaire and physical assessments will determine subjects comfort and safety. The physical assessment consists of a ten minute walk on a treadmill, at a self-selected pace. A balancing test on a SMART Balance Master will also be used to assess subject safety, by utilizing the limits of stability protocol. Subjects' will be required to wear the prosthesis given to them for one week before returning for a follow-up appointment. On the third visit, the subjects' will return the first prosthesis to the investigators of the study, where an additional socket will be given to the subject for the second portion of this study. Subjects will be evaluated with a questionnaire and physical assessments to determine comfort and safety. Participants will be required to wear the prosthesis given to them for one week before returning for a follow-up appointment. During the final appointment, the subjects will return all devices given to them to an investigator of the study.

Eligibility criteria: Inclusion Criteria:

* Transtibial amputee with mature limb
* Minimum of 3-years of prosthetic use
* Capable of ambulating on a treadmill for ten minutes
* Minimum age of 18 years old
* Both Unilateral and Bilateral Amputees
* K-Level K2-K4

Exclusion Criteria:

* Any open wounds/ulcerations on the residual limb
* Skin allergies to silicone or latex
* Unmanaged co-morbidities such a diabetes and congestive heart failure

Primary outcomes:
measure: Balance
timeFrame: Change in balance between Week 2 and Week 3 of study
Secondary outcomes:
measure: Socket liner integrity
timeFrame: Change in socket liner between Week 2 and Week 3 of study
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda Universtiy
state: California
Study officials:
affiliation: Loma Linda University
name: Gurinder Bains, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00847353: Normal Values of High Frequency ECG (HyperQ™) in Apparently Healthy Individuals and in Young and Masters Athletes
Official title: Normal Values of High Frequency ECG (HyperQ™) in Asymptomatic, Apparently Healthy Normal Weight vs. Obese Individuals and in Young and Masters Athletes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Healthy
Asymptomatic
Obesity
Keywords: high frequency ECG
normal values
asymptomatic
obese
Lead sponsor: BSP Biological Signal Processing Ltd.
Sponsor class: INDUSTRY
First posted: 2009-02-19
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: community sample referred or self referred to stress testing

Brief summary: The main objective of this study is to investigate depolarization characteristics represented by changes in HyperQ in asymptomatic, apparently healthy athletic and non-athletic individuals. We also aim to examine a subgroup of obese and non-obese subjects. The goal of the study is to establish normal HyperQ values in these populations and compare HyperQ values of age-matched athletic vs. non-athletic individuals of similar health status.


Eligibility criteria: Inclusion Criteria:

* An asymptomatic, apparently healthy patient performing a maximal exercise stress test

Exclusion Criteria:

* Contraindications for an exercise test
* Wolff-Parkinson-White (pre-excitation) syndrome
* Atrial Fibrillation or significant ventricular arrhythmia
* Treatment with Digoxin
* Pacemaker
* Pregnancy or suspected pregnancy
* QRS duration\>120ms or other conduction delays

Primary outcomes:
measure: Normal values for depolarization characteristics will be established for study groups
timeFrame: end of data collection
Secondary outcomes:
Other outcomes:
Locations:
city: Netanya
country: Israel
facility: The Ribstein Center for Sports Medicine and Research
Study officials:
References:
Clinical trial NCT00834353: Prospective Study of N-acetyltransferase2 (NAT2) and Cytochrome P4502E1 (CYP2E1) Gene as Susceptible Risk Factors for Antituberculosis (ATT) Induced Hepatitis
Official title: Prospective Study of N-acetyltransferase2 (NAT2) Gene and Rifampicin Induced Cytochrome P-450 as Susceptible Risk Factors for Antituberculosis Drug Induced Hepatitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Tuberculosis
Lead sponsor: Maulana Azad Medical College
Sponsor class: OTHER
First posted: 2009-02-03
Sex: ALL
Minimum age (years): 10
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Cases are enrolled in the study from primary care clinic after they are diagnosed with pulmonary tuberculosis.

Brief summary: N-acetyltransferase2 (NAT2) and Cytochrome P4502E1 (CYP2E1) are two drug metabolizing enzymes. Antituberculosis drug isoniazid is acetylated by NAT2 and forms ultimately a nontoxic compound which is metabolized by CYP2E1 to a toxic metabolite. Slow acetylator genotype of NAT2 and wild type genotype of CYP2E1 gene has been attributed to greater toxicity of ATT drug. Therefore this study has been designed to analyze the genetic polymorphism of NAT2 and CYP2E1 genes in tuberculosis patients who developed drug induced hepatitis upon administration of antituberculosis drug.Polymorphism study of NAT2 and CYP2E1 gene may help in predicting the high risk group of ATT induced hepatitis.


Eligibility criteria: Inclusion Criteria:

* Patients with pulmonary tuberculosis
* Patients receiving conventional antituberculosis drugs
* Patients who directly presented with antituberculosis drug induced hepatitis

Exclusion Criteria:

* Habitual alcohol drinkers
* Patients with evidence of viral hepatitis

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Premashis Kar
Study officials:
affiliation: Maulana Azad Medical College, Department of Medicine.
name: Premashis Kar, MD,DM
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02521753: Omega 3 Polyunsaturated Fatty Acids (PUFA) or Magnesium in Obese Polycystic Ovary Syndrome Patients
Official title: Effect Polyunsaturated Fatty Acids or Magnesium in Metabolic, Hormonal, and Inflammatory Profile in Obese Women With Polycystic Ovary Syndrome. A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Polycystic Ovary Syndrome
Obesity
Keywords: Polycystic ovary syndrome
Obesity
Metformin
Magnesium
Polyunsaturated fatty acids
Lead sponsor: Coordinación de Investigación en Salud, Mexico
Sponsor class: OTHER_GOV
First posted: 2015-08-13
Enrollment: 123
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Polycystic ovary syndrome (PCOS) is the most prevalent endocrine disorder in reproductive age women. PCOS is usually characterized by an excessive androgen production, menstrual irregularities, and polycystic ovaries. Women with PCOS are often obese and have a varying degree of insulin resistance (IR). Weight reduction constitutes the initial treatment for these patients. Metformin has proven to be useful in IR and is frequently used in PCOS. However metformin use may be accompanied by gastrointestinal discomfort, and a high abandon rate. Other therapeutic alternatives such as magnesium and polyunsaturated fatty acids have been used in other IR states and may be useful in PCOS. The aim of this study is to asses the efficacy of these alternatives in obese PCOS patients.

Detailed description: Polycystic Ovary Syndrome (PCOS)

Eligibility criteria: Inclusion Criteria:

* Polycystic Ovary Syndrome according to Rotterdam criteria,
* BMI ≥ 27 Kg/m2

Exclusion Criteria:

* Type 2 diabetes mellitus,
* in treatment for polycystic ovary syndrome features

Primary outcomes:
measure: Metabolic profile
timeFrame: Six months after intervention
Secondary outcomes:
measure: Hormonal profile
timeFrame: Six months after intervention
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Hospital de Gineco Obstetricia Centro Médico "La Raza"
state: D.f.
Study officials:
affiliation: Instituto Mexicano del Seguro Social
name: Mardia Guadalupe López Alarcón, MD, phD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02960451: PRIME vs Usual Care for Clinical High Risk
Official title: Randomized Trial of Usual Care vs. Specialized, Phase-specific Care for Youth at Risk for Psychosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Clinical High Risk Syndrome for Psychosis
Keywords: prodrome
cognitive behavioral therapy
family focused therapy
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2016-11-09
Enrollment: 16
Sex: ALL
Minimum age (years): 12
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to determine whether specialty care is superior to usual care in the treatment of patients at clinical high risk for psychosis.

Detailed description: This study is a randomized clinical effectiveness trial for patients at clinical high risk for psychosis that compares two treatments: 1) specialty care delivered in a specialized clinical for patients at clinical high risk for psychosis versus 2) treatment as usual in the community.

Eligibility criteria: Inclusion Criteria:

* Subjects must meet all of the following:

  1. Male or female between 12 and 30 years old.
  2. Understand and sign an informed consent (or assent for minors) document in English.
  3. Meet diagnostic criteria for prodromal syndrome as per COPS criteria.

Exclusion Criteria:

* Subjects must not meet any of the following:

  1. Diagnosis of current or lifetime Axis I psychotic disorder, including mood disorder with psychotic symptoms.
  2. Impaired intellectual functioning (full-scale IQ\<70). However, those with an IQ in the 65-69 range will not be excluded if they score \>75 on the WRAT Reading.
  3. Past or current history of a clinically significant central nervous system disorder that may contribute to prodromal symptoms or confound their assessment.
  4. Alcohol or substance dependence in the past 6 months.

Primary outcomes:
measure: Global Assessment of Functioning
timeFrame: 24 months
Secondary outcomes:
measure: Service utilization
timeFrame: 24 months
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Prevention through Risk Identification Management and Education (PRIME) Clinic
state: Connecticut
Study officials:
affiliation: Yale University
name: Scott Woods, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00381251: Study Comparing Bioequivalence of Two New Formulations of Premarin/MPA With Premarin/MPA Reference Formulation.
Official title: An Open-Label, Single-Dose, Randomized, 3-Period, Crossover, Bioequivalence Study Between Two New Formulations of 0.45 mg/1.5 mg Premarin / Medroxyprogesterone Acetate (MPA) Compared With a Reference Formulation of 0.45mg/1.5mg Premarin / MPA (Prempro™) in Healthy Postmenopausal Women.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Postmenopausal Osteoporosis
Postmenopause
Keywords: vaginal atrophy
postmenopausal osteoporosis
menopause
hot flashes
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2006-09-27
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: This study will compare the bioequivalence of two new investigational combination formulations of Premarin and medroxyprogesterone acetate (MPA) with a currently marketed formulation of Premarin and medroxyprogesterone, Prempro™.

Prempro is indicated for use after menopause in women with a uterus to reduce moderate to severe hot flashes; to treat moderate to severe dryness, itching, and burning, in and around the vagina; and to help reduce your chances of getting osteoporosis (thin weak bones). The purpose of this study is to determine if these new formulations of Premarin and MPA provide the same levels of estrogen and MPA in the blood as Prempro in healthy postmenopausal women.


Eligibility criteria: Inclusion Criteria:

* Healthy, postmenopausal women ages 35 to 70 years, inclusive.
* Naturally postmenopausal women must not have had a menstrual period for at least six months, but less than 12 months, as confirmed by a blood test; or for at least 12 months with no blood hormone test confirmation. Naturally postmenopausal women must not have had a menstrual period since the age of 54. Surgically menopausal women must have undergone bilateral oophorectomy (removal of both ovaries) at least 5 months prior to the start of the study, and the surgical report may be requested to confirm the surgery date and that the surgery was not due to a cancerous condition.
* Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history. Must be able to abstain from smoking during the inpatient stay.

Primary outcomes:
measure: Pharmacokinetic blood samples for unconjugated and total (unconjugated plus conjugated) estrogens and MPA will be obtained. The following pharmacokinetic parameters will be determined: Cmax, Tmax, t½, AUC0-T, AUC0-¥.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Trial Manager
role: STUDY_DIRECTOR
References:
Clinical trial NCT00208351: A Randomised Single Centre Study to Compare the Long-term Performance of 4 Designs of the DePuy Ultima LX Stem in Primary Total Hip Replacement
Official title: Clinical and Radiographic Evaluation to Compare a Polished and Non-polished Collared Stem and a Polished and Non Polished Collarless Stem in Primary Total Hip Replacement
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Osteoarthritis
Post-traumatic Arthritis
Collagen Disorder
Avascular Necrosis
Traumatic Femoral Fractures
Nonunion of Femoral Fractures
Congenital Hip Dysplasia
Slipped Capital Femoral Epiphysis
Keywords: Hip
Cemented
Lead sponsor: DePuy International
Sponsor class: INDUSTRY
First posted: 2005-09-21
Enrollment: 164
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the performance of 4 designs of the DePuy Ultima LX hip stem in the treatment of patients with hip joint disease requiring a total hip replacement. Patients who enter the study will be randomly allocated to one of the 4 designs of the DePuy Ultima LX hip stem and will be evaluated at regular intervals following hip surgery using patient, clinical and x-ray assessments.


Eligibility criteria: Inclusion Criteria:

Current indications for primary total hip arthroplasty utilising a cemented femoral component. These include pain, deformity and loss of function which are not responsive to medical treatment

Exclusion Criteria:

i) Revision Total Hip Arthroplasty ii) Rheumatoid arthritis iii) Age greater than 80 years at time of surgery iv) Age less than 60 years at time of surgery v) Previous hip joint sepsis vi) Obesity vii) Patient likely to remain housebound once rehabilitation is complete

Primary outcomes:
measure: Stem movement measured radiographically at 2 years
timeFrame: 2yrs post-surgery
Secondary outcomes:
measure: Comparisons of Visual Analog Pain (VAS), 36-Item Short Form Health Survey (SF-36), Satisfaction, Limb Length and stem movement measured radiographically at 5 years.
timeFrame: 5yrs post-surgery
Other outcomes:
Locations:
city: Surrey
country: United Kingdom
facility: Epsom General Hospital
Study officials:
References:
citation: Hutt J, Hazlerigg A, Aneel A, Epie G, Dabis H, Twyman R, Cobb A. The effect of a collar and surface finish on cemented femoral stems: a prospective randomised trial of four stem designs. Int Orthop. 2014 Jun;38(6):1131-7. doi: 10.1007/s00264-013-2256-z. Epub 2014 Jan 29.
Clinical trial NCT02635451: The Relation Between Serum Ascorbic Acid Concentration and Preterm Premature Rupture of Membranes
Official title: The Relation Between Serum Ascorbic Acid Concentration and Preterm Premature Rupture of Membranes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Preterm Premature Rupture of Membranes
Keywords: vitamin c
Preterm Premature Rupture of Membranes
Lead sponsor: Ain Shams Maternity Hospital
Sponsor class: OTHER
First posted: 2015-12-18
Enrollment: 40
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: This study will be conducted at the department of Obstetrics and Gynecology recruiting pregnant women selected from the attendees of antenatal clinic, emergency department and from inpatient wards of Ain Shams University Maternity Hospital starting from January 2016.

This study will include 40 pregnant women between 28-37 weeks were recruited.

Brief summary: To study the association between maternal serum vitamin C concentration in women with preterm premature rupture of membranes (PPROM) and women without PPROM.

Detailed description: The micronutrient vitamin C is an effective water soluble antioxidant that scavenges several reactive oxygen species, thus reducing oxidative stress, It also acts as an enzymatic cofactor to the enzymes lysyl hydroxylase and prolyl hydroxylase, which is required for synthesis of hydroxyproline and hydroxylysine, Collagen requires hydroxyproline bridges across the triple helix to provide stability to it, Ascorbic acid also causes down regulation of the metalloproteinase-2 and biosynthesis of collagen where it is required for the formation of triple helical structure of collagen. Thus, ascorbic acid participates in the equilibrium between synthesis and degradation of collagen and this may be critical in reducing the occurrence of preterm PROM.

Eligibility criteria: Inclusion Criteria:

* Singleton pregnancies
* Gestational age between 28-37 weeks
* Rupture of membranes will be diagnosed by history, sterile speculum examination to confirm fluid leakage from the cervical canal

Exclusion Criteria:

* Patients with multiple pregnancies
* Smoker
* Polyhydramnios
* Maternal diseases such as: anemia, diabetes, UTI, RTI and vaginal infection
* History of PPROM in previous pregnancies
* Evidence of chorioamnionitis in current pregnancy

Primary outcomes:
measure: relation between serum vitamin C concentration and PPROM
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Professor of Obstetric and Gynecology
name: Sherif M Habib, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04884451: Evaluation of a Stage-Based Tailored, Nutrition Education Package for Childhood Obesity (ST-NEPCO) (7-12 Years Old)
Official title: Evaluation of a Stage-Based Tailored, Nutrition Education Package for Childhood Obesity (ST-NEPCO) (7-12 Years Old)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Educational Materials (ST-NEPCO) During Nutrition Counselling for Obese Children
Lead sponsor: Universiti Putra Malaysia
Sponsor class: OTHER
First posted: 2021-05-13
Enrollment: 60
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized controlled trial will be used to determine the effectiveness of ST-NEPCO. The study will involve obese children aged 7 to 11 years old. Participants will be assigned randomly to either the intervention or control group. The intervention group will receive counselling from the researcher based on ST-NEPCO, meanwhile the control group will receive counseling from dietitians based on the routine care for the management of childhood obesity. The study will be conducted for duration of 24 weeks. The individual counseling session will be held once a month for each participant during the weekend.


Eligibility criteria: Inclusion Criteria:

* Children aged 7 to 11 years old
* Children classified as obese (\>+2SD) based on BMI-for-age for 5 to 19 years old (WHO, 2007).

Exclusion Criteria:

* Children diagnosed with chronic asthma, diabetes mellitus, psychiatric disorders (e.g. schizophrenia, severe autism or mental retardation, or psychosis), or other serious medical conditions.
* Children receiving medications that can potentially promote weight gain or weight loss.
* Children participating in any weight management program

Primary outcomes:
measure: BMI-for-age z -score change
timeFrame: Change from baseline to week 24
Secondary outcomes:
measure: Body composition (BMI, Lean Body Mass (LBM), Body Fat Mass (BFM) change
timeFrame: Change from baseline to week 24
measure: Waist and hip circumferences change
timeFrame: Change from baseline to week 24
measure: Energy and nutrient intakes [macronutrients, Saturated Fatty Acids (SFA), sugar and dietary fibre] change
timeFrame: Change from baseline to week 24
measure: Physical activity score change
timeFrame: Change from baseline to week 24
measure: Stage of readiness to lose weight change
timeFrame: Change from baseline to week 24
Other outcomes:
Locations:
city: Serdang
country: Malaysia
facility: Universiti Putra Malaysia Teaching Hospital
state: Selangor
Study officials:
References: