louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02404701: Effect of Over-the-counter Dietary Supplements on Kidney Stone Risk
Official title: Effect of Over-the-counter Dietary Supplements on Kidney Stone Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperoxaluria
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2015-03-31
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to ascertain whether certain supplements promote excessive urinary oxalate excretion and increase the risk for calcium oxalate kidney stones. Supplements that enhance urinary oxalate excretion, as a result of their oxalate concentration or from some other mechanism (e.g., providing substrate for oxalate biosynthesis) will be identified by the investigators.

Detailed description: The investigators hypothesize that certain over-the-counter dietary supplements will increase urinary excretion of oxalate as measured in 24-h urine collections. The investigators further hypothesize that the concentration of oxalate in dietary supplements may not be associated with urinary oxalate excretion, suggesting that other nutritional components of the supplements may be exerting an influence over oxalate biosynthesis, oxalate absorption in the gastrointestinal tract, and/or renal oxalate handling. These other factors include the form of oxalate in the supplement (water- vs. non water-soluble) and the supplement's concentration of ascorbic acid.

Eligibility criteria: Inclusion Criteria:

* At least 18 years of age, no prior personal history of kidney stones

Exclusion Criteria:

* Personal history of kidney stones (by subjects' report); known allergy to any of the dietary supplements to be used in the study (by subjects' report); short bowel; active ulcerative colitis or irritable bowel disease; Crohns or Celiac disease; renal tubular acidosis; current use of topiramate or other carbonic anhydrase inhibitor, steroids, allopurinol, thiazide diuretics, or supplemental ascorbic acid \>250 mg/day.

Primary outcomes:
measure: Within-subject change in 24-hour urinary oxalate excretion from before and after supplementation
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: Department of Urology, School of Medicine & Public Health, University of Wisconsin
state: Wisconsin
Study officials:
affiliation: Department of Urology, University of Wisconsin School of Medicine and Public Health
name: Kristina L Penniston, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05258201: Effect of Muscle Energy Technique Versus Strain-counterstrain on Upper Trapezius Trigger Points
Official title: Effect of Muscle Energy Technique Versus Strain-Counterstrain on Upper Trapezius Myofascial Active Trigger Points. A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trigger Point Pain, Myofascial
Keywords: Muscle Energy Technique
Myofascial
Trigger Point
Upper Trapezius
Strain-counterstrain
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-02-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 34
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aim of the study To determine the comparative effects of muscle energy technique and strain counter strain in upper trapezius trigger point.

Detailed description: A Randomized Controlled trial will be conducted after approval of synopsis. To enroll patients Purposive sampling technique will be used. Patients will be selected according to the pre-defined inclusion and exclusion criteria. The enrolled patients will be allocated into two groups, group A and group B. On Group A muscle energy technique will be applied for 30 seconds and repeat 3 to 5 times per on treatment session and Group B will be treated with strain counter strain for 20-30 seconds and repeat this process for up to five times. Assessment will be done at baseline, 2nd week, 4th week and 6th week of treatment. Follow up will be assessed 15 days after completion of treatment protocol. The patients' outcome will be measured by Visual Analog Scale for pain intensity and Neck Disability Index . Informed consent will be taken from each patient. Statistical Package of Social Sciences software, version 20 will be used for the analysis of data.

Eligibility criteria: Inclusion Criteria:

1. Participants who are 18 to 34 years old
2. In upper trapezius From 2 weeks Had mechanical neck pain and was diagnosed with active myofacial Trigger points
3. Subjects have to exhibit a tendor point in the upper trapezius muscle either on the left or right side
4. Local pain is greater than 3/10 on Visual Analog scale

Exclusion Criteria:

1. Patient with cervical radiculopathy
2. Patients with Fibromyalgia syndrome
3. Patients who had cervical spine surgery
4. Patient with myelopathy
5. Patients who had myofacial pain therapy

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: 12th Week
measure: Neck Disability Index
timeFrame: 12th Week
measure: Goniometer
timeFrame: 12th Week
Secondary outcomes:
Other outcomes:
Locations:
city: Faisalabad
country: Pakistan
facility: Ripah International University
state: Punjab
Study officials:
affiliation: Riphah International University
name: Muhammad Kashif
role: STUDY_CHAIR
References:
Clinical trial NCT04449601: Normotensive and Hypertensive Placental Abruptions
Official title: Comparison of Maternal Neonatal Outcomes of Normotensive and Hypertensive Placental Abruptions: A Novel Approach
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Abruptio Placentae; Affecting Fetus or Newborn
Keywords: Abruptio placenta
complete blood count
hypertension
perinatal outcome.
mean platelet volume
Lead sponsor: Kayseri Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2020-06-29
Enrollment: 115
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Two groups were formed according to presence or absence of hypertension (53 hypertensive, 62 normotensive) who has placental abruption.

Brief summary: Placental abruption is a significant cause of both maternal morbidity and neonatal morbidity and mortality. Most abruptions accept to be related to a chronic placental disease process. Therefore, it is very important to understand these processes. To analyze maternal and neonatal effects of placental abruption(PA) through a novel classification in the presence of hypertension. Initial hemoglobin parameters were also compared to predict pregnancy outcomes in addition to hypertension.

Detailed description: Objective: We aimed to classify placental abruption according to hypertension status.

Methods: This retrospective cohort designed study was conducted on 115 pregnant women with placental abruption. The main parameters scanned and recorded from the hospital database and patient medical files. Two groups were classified regarding of presence or absence of hypertension (53 hypertensive, 62 normotensive). Maternal demographical and clinical characteristics (abdominal pain, vaginal bleeding) were recorded. APGAR scores below 5 at 1 and 5 min., fetal or neonatal death, admission and length of stay in Neonatal Intensive Care Unit(NICU) were also investigated and compared between the groups.

Eligibility criteria: Inclusion Criteria:

* spontaneous,
* singleton pregnancies
* above 25 weeks of gestations with positive fetal cardiac activity

Exclusion Criteria:

* multiple gestations,
* presence of fetal or maternal infection,
* chronic inflammatory diseases or connective tissue disorders
* history of myocardial infarction,
* thrombosis
* history of steroid drug usage.

Primary outcomes:
measure: blood pressure measurement
timeFrame: 2 minute
Secondary outcomes:
measure: hemogram parameters WBC(white blood cell) ,PLT(Platelet), MPV(mean platelet volume), HGB(hemoglobin), Neutrophil lymphocyte ratio..)
timeFrame: first 1 hour
measure: maternal and newborn length, weight
timeFrame: 5 minute
measure: APGAR score
timeFrame: 5 minute
Other outcomes:
Locations:
Study officials:
affiliation: Kayseri Education and Research Hospital
name: Hatice Akkaya, Ass Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06114901: Efficacy of Mobile-delivered Sleep Restriction Therapy for Treatment of Insomnia Disorder: Randomised Controlled Trial
Official title: Efficacy of Mobile-delivered Sleep Restriction Therapy for Treatment of Insomnia Disorder: Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Insomnia
Keywords: CBTi
Digital CBTi
Insomnia
Lead sponsor: Woolcock Institute of Medical Research
Sponsor class: OTHER
First posted: 2023-11-02
Enrollment: 558
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Online (digital), two-arm, open-label randomised clinical trial
Primary purpose: TREATMENT

Brief summary: The "SleepFix Study" is a clinical trial designed to evaluate the efficacy of mobile-delivered sleep restriction therapy (dBTi) in comparison to digital sleep health education (control) for treating insomnia disorder in adults aged 18 and above. The study is conducted entirely online, with 558 participants (279 in each group) and aims to determine the impact of the interventions on insomnia symptom severity, sleep metrics, subjective sleep quality, fatigue, anxiety, depressive symptoms, quality of life, medication usage, and workforce productivity.


Eligibility criteria: Inclusion Criteria:

* Adults aged ≥ 18 years
* Able to give informed online consent
* Insomnia Severity Index ≥ 12
* English fluency
* Access to a smartphone and willingness/proficiency to use a mobile application

Exclusion Criteria:

* Shift-workers (at least 2 night shifts a week between the hours of 8 pm to 8 am)
* Serious medical and/or psychiatric illnesses/disorders
* Previously diagnosed or suspected/high-risk of undiagnosed sleep disorders (e.g. REM Sleep Behaviour Disorder, Restless Leg Syndrome
* Currently receiving Cognitive Behavioural Therapy for insomnia (CBT-i)
* Operators of machinery that require high alertness (e.g. truck drivers, train drivers, pilots, etc)
* Pregnant women

Primary outcomes:
measure: Change in insomnia symptom severity change
timeFrame: 8 weeks
Secondary outcomes:
measure: Change in sleep-wake metrics
timeFrame: 8 weeks
measure: Daytime symptoms of fatigue
timeFrame: 8 weeks
measure: Change in anxiety scores
timeFrame: 8 weeks
measure: Change in depressive symptom scores
timeFrame: 8 weeks
measure: Change in quality of life scores
timeFrame: 8 weeks
measure: Treatment usability
timeFrame: 8 weeks
measure: Workforce productivity
timeFrame: 8 Weeks
measure: Sleep medication usage
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Woolcock Institute of Medical Research
state: New South Wales
Study officials:
affiliation: Macquarie University, Woolcock Institute of Medical Research
name: Christopher Gordon, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00184301: A Comparison Study of Treatments Given to Patients With Concurrent Eating Disorder and Personality Disorder.
Official title: Treatment of Patients With Concurrent Eating Disorder and Personality Disorder: A Controlled Randomized Comparison Study, of Treatments Given to In-patients and Out-patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eating Disorder
Anorexia Nervosa
Bulimia Nervosa
Personality Disorder
Keywords: Eating disorders
Anorexia nervosa
Bulimia nervosa
Personality disorders
In-patient treatment
out-patient treatment
group therapy
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
name: Norwegian Foundation for Health and Rehabilitation
First posted: 2005-09-16
Enrollment: 43
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to determine whether in-patient treatment is better then intensive out-patient group treatment for patients with concurrent eating disorder and personality disorder.

Detailed description: The main aim of the study is to compare the effects of in-patient treatment with a group based intensive out-patient treatment. It is a randomized controlled comparison study including patients with concurrent eating disorder and personality disorder. 18 patients will receive an in-patient treatment lasting one year. 18 patients will receive intensive out-patient treatment consisting of two-weekly group sessions, lasting one year. Personality disorder, eating behavior, symptoms, and function will be followed for two years.

Eligibility criteria: Inclusion Criteria:

* Anorexia nervosa, bulimia nervosa, personality disorder.

Exclusion Criteria:

* male, schizophrenia.

Primary outcomes:
measure: Score on personality, interpersonal, eating disorder and symptom scales
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Østmarka Psychiatric Department, St Olavs Hospital, University Hospital of Trondheim.
Study officials:
affiliation: Norwegian University of Science and Technology
name: Are Holen, PhD MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04629001: Effect of Covid-19 on Outcomes of Pregnancy
Official title: Effect of Covid-19 on Outcomes of Pregnancy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pregnancy Without Complications Except Getting Covid-19 Infection
Keywords: pregnancy
Covid-19
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-11-16
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female in Reproduction age

Brief summary: To study the effect of getting Covid-19 infection during pregnancy on the outcomes of the mother and the fetus including morbidity and mortality


Eligibility criteria: Inclusion Criteria:

* Normal single pregnancy

Exclusion Criteria:

* Pregnancy with any chronic diseases
* Multiple pregnancy

Primary outcomes:
measure: Fetal morbidity
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Medicine
Study officials:
References:
Clinical trial NCT01273701: Combination of Psychosocial Intervention and Slow Prosecutions for the Treatment of Methamphetamine Abuse/Dependence
Official title: Combination of Psychosocial Intervention and Slow Prosecutions for the Treatment of Methamphetamine Abuse/Dependence
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Amphetamine Abuse
Amphetamine Dependence
Methamphetamine Abuse
Methamphetamine Dependence
Keywords: amphetamine
methamphetamine
psychosocial intervention
contingency management
slow prosecution
substance use disorder
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2011-01-10
Enrollment: 60
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: TREATMENT

Brief summary: The hospital where this study will be conducted is responsible for the one-year contingency management treatment for methamphetamine drug offenders referred from the Yunlin District Prosecutors Office. Completing the one-year treatment is prerequisite for offenders to get slow prosecutions.

It is an open-label, parallel-group trial comparing the combination of psychosocial intervention and slow prosecutions with psychosocial intervention alone in treating subjects with methamphetamine dependence

Study Hypothesis

1. Psychosocial interventions in combination with slow prosecutions is more effective than psychosocial interventions alone to achieve abstinence for subjects with methamphetamine abuse/dependance.
2. Inclusion of telephone reminding before each visit will enhance the retention rate and abstinence rate.


Eligibility criteria: Inclusion Criteria:

* DSM-IV-TR criteria for amphetamine/methamphetamine abuse or dependence
* 18 - 65 years old
* For TSTSU-N and TSTSU-T arms: methamphetamine offenders referred by the Yunlin District Prosecutors Office
* For OPD arm: psychiatric outpatients referred from the psychiatry clinics in National Taiwan University Hospital, Yunlin Branch

Exclusion Criteria:

* Concurrent use of other illicit substances
* Co-morbidity with major psychotic disorders (schizophrenia, schizoaffective disorder, other psychotic disorder), mental retardation, acute episodes of major depressive disorder or bipolar affective disorder) or serious personality disorders.

Primary outcomes:
measure: Endpoint abstinence rate
timeFrame: At the end of one-year treatment
Secondary outcomes:
measure: Retention rate
timeFrame: during the whole one-year treatment
measure: Length of retention
timeFrame: during the whole one-year treatment
measure: The longest period of abstinence
timeFrame: during the whole one-year treatment
Other outcomes:
Locations:
city: Yunlin
country: Taiwan
facility: National Taiwan University Hospital Yunlin Branch
Study officials:
affiliation: Department of Psychiatry, National Taiwan University Hospital Yunlin Branch
name: Yi-Ting Lin, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06412601: Happy Bob App: a Preliminary Evaluation of Its Use in Youth with Diabetes
Official title: Happy Bob App: a Preliminary Evaluation of Its Use in Youth with Diabetes
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Type 1 Diabetes
Lead sponsor: Children's Mercy Hospital Kansas City
Sponsor class: OTHER
First posted: 2024-05-14
Enrollment: 80
Sex: ALL
Minimum age (years): 13
Maximum age (years): 215
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The goal of this clinical trial is to evaluate the impact of peer support via the Happy Bob phone app in youth with Type 1 Diabetes.

The main questions it aims to answer are: What is the usability and acceptability of the app? What is the app's efficacy on measures such as treatment adherence and social support? And how are these effects impacted by remote patient monitoring by clinic staff?

Participants will use the Happy Bob app for 6 months and will complete a series of surveys at the start, middle, and end of their use of the app. Some participants will participate in 2 remote patient monitoring sessions when beginning their use of the app.


Eligibility criteria: Inclusion Criteria:

Diagnosis of Type 1 Diabetes, Use Dexcom and Smart Phone

Exclusion Criteria:

Non-English Speaking

Primary outcomes:
measure: Happy Bob App User Metrics
timeFrame: 6 months
measure: Type 1 Diabetes and Life (T1DAL) Measure
timeFrame: 0,3,6 months
measure: Positive and Negative Affect Schedule (PANAS)
timeFrame: 0,3,6 months
measure: Diabetes Treatment Satisfaction Questionnaire
timeFrame: 0,3,6 months
measure: Social Support Questionnaire for Children (SSQC)
timeFrame: 0,3,6 months
measure: Health Information Technology Usability Evaluation Scale (Health-ITUES)
timeFrame: 0,3,6 months
Secondary outcomes:
measure: Self Efficacy for Diabetes (SED) Scale
timeFrame: 0,3,6 months
measure: Diabetes Treatment Outcomes
timeFrame: 6 months
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
Study officials:
References:
Clinical trial NCT04063501: Longitudinal Evaluation of Microbial and Host Signatures During Immunotherapy for Lung Cancer
Official title: Longitudinal Evaluation of Microbial and Host Signatures During Immunotherapy for Lung Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Cancer
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-08-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with a diagnosis of advanced stage unresectable Non-Small Cell Lung Cancer and indication for PD-1 blockade treatment (either as monotherapy or combined with chemotherapy)

Brief summary: This study will prospectively collect airway, stool, and blood samples on 80 subjects with lung cancer undergoing immunotherapy. Investigators will evaluate airway/stool microbial signatures associated with local (lower airway) and systemic (blood) immune tone.They will then study whether microbiota and/or host signatures predict subjects' response by longitudinal assessment of the progression free survival. They will also repeat sampling after 8 weeks of immunotherapy to expand our mechanistic understanding of the response to treatment.


Eligibility criteria: Inclusion Criteria:

* Adult patients with a diagnosis of advanced stage unresectable Non-Small Cell Lung Cancer and indication for PD-1 blockade treatment (either as monotherapy or combined with chemotherapy)

Exclusion Criteria:

* Antibiotic, steroid, or chemotherapy received within the prior month since these are possible confounders that may impact the microbiome and the host immunity.
* Brain metastasis (as evaluated by MRI obtained as part of standard of care staging evaluation)
* FEV1\<50% predicted
* Cardiovascular disease (defined as abnormal EKG, known or suspected coronary artery disease or congestive heart failure)
* Renal disease
* Coagulopathy
* Liver disease

Primary outcomes:
measure: Progression-free survival (PFS)
timeFrame: 3 Years
measure: Microbiota signatures in lower and upper airways
timeFrame: 3 Years
measure: Microbiota signatures in stool
timeFrame: 3 Years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: New York Langone Health
name: Leopoldo N Segal, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: