louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05418075: Evaluation of the Effectiveness of Add-on Hometreatment to Family Based Therapy in Adolescent Anorexia Nervosa.
Official title: Evaluation of the Effectiveness of Add-on Hometreatment to Family Based Therapy in Adolescent Anorexia Nervosa. A Randomised Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anorexia in Adolescence
Lead sponsor: Psychiatric University Hospital, Zurich
Sponsor class: OTHER
First posted: 2022-06-14
Enrollment: 90
Sex: ALL
Minimum age (years): 12
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The project serves to evaluate a new treatment method with outreach services as a supplement to family-based therapy in the treatment of children and adolescents with eating disorders.

The project is intended to help identify different family structures and which families will benefit most from the new outreach service of home-based treatment.


Eligibility criteria: Inclusion Criteria:

* Children and adolescents aged 12 -20 years.
* Successful registrations in the special consultation for eating disorders at the Clinic for Child and Adolescent Psychiatry and Psychotherapy (KJPP) of the Psychiatric University Hospital (PUK) Zurich.
* Diagnosis of anorexia nervosa or atypical anorexia nervosa (ICD-10 F50.00/ F50.01/ F50.1)
* Existing informed consent of patients\* (14 years and older) and parents or legal guardians (12-14 years).
* IQ over 75
* Resident in the canton of Zurich
* Good knowledge of German

Exclusion Criteria:

* No written consent
* Children under 12 years
* Other forms of eating disorders apart from anorexia nervosa or atypical anorexia nervosa.

Primary outcomes:
measure: Symptomatic improvement
timeFrame: 3 months
measure: Symptomatic improvement
timeFrame: 3 months
measure: Symptomatic improvement
timeFrame: 3 months
Secondary outcomes:
measure: State of health improvement
timeFrame: 3 months
measure: Remission rate
timeFrame: 12 months
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Psychiatrische Universitätsklilnik Zürich
Study officials:
References:
Clinical trial NCT02311075: Mechanisms of Endothelial Dysfunction in Type 2 Diabetes
Official title: Determination of the Mechanisms Involved in Conduit Artery Endothelial Dysfunction in Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2014-12-08
Enrollment: 48
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Endothelial dysfunction of conduit arteries plays an important role in the development of cardiovascular complications associated with type 2 diabetes. In order to propose targeted therapeutic approaches, this study aim to determine the mechanisms involved in endothelial dysfunction of conduit arteries in these patients.


Eligibility criteria: Inclusion Criteria:

- Type 2 diabetic patients or control subjects or healthy volunteers

Exclusion Criteria:

* Macroangiopathy
* Insulin treatment
* Chronic kidney disease (eGFR\<60 ml/min/m²)
* Hyperlipidemia (total cholesterol\>2.5 g/l)
* Smoking habit \> 5 cigarettes/day
* Pregnancy

Primary outcomes:
measure: Change from Baseline in EET concentration during endothelial stimulation
timeFrame: 30 min from the beginning of hand skin heating
Secondary outcomes:
measure: Change from Baseline in NO concentration during endothelial stimulation
timeFrame: 30 min from the beginning of hand skin heating
measure: Change from Baseline in ET-1 concentration during endothelial stimulation
timeFrame: 30 min from the beginning of hand skin heating
measure: Change from Baseline in ROS concentration during endothelial stimulation
timeFrame: 30 min from the beginning of hand skin heating
Other outcomes:
Locations:
city: Rouen
country: France
facility: Rouen University Hospital
Study officials:
affiliation: University Hospital, Rouen
name: Robinson JOANNIDES, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Duflot T, Moreau-Grange L, Roche C, Iacob M, Wils J, Remy-Jouet I, Cailleux AF, Leuillier M, Renet S, Li D, Morisseau C, Lamoureux F, Richard V, Prevost G, Joannides R, Bellien J. Altered bioavailability of epoxyeicosatrienoic acids is associated with conduit artery endothelial dysfunction in type 2 diabetic patients. Cardiovasc Diabetol. 2019 Mar 18;18(1):35. doi: 10.1186/s12933-019-0843-z.
Clinical trial NCT05826275: Phase 1 Trial in Patients With Human Papillomavirus (HPV)-Associated Cancer
Official title: A Phase 1 Trial of TGN-S11 in Patients With Human Papillomavirus (HPV)-Associated Relapsed, Resistant or Metastatic Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: HPV Associated Cancers
Lead sponsor: Toragen, Inc.
Sponsor class: INDUSTRY
First posted: 2023-04-24
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Phase I, dose escalation/dose expansion study. Expansion Phase will begin in parallel one dose level lower than the highest dose deemed safe in the Dose Escalation in combination with a PD-1 checkpoint blockade.
Primary purpose: TREATMENT

Brief summary: This is an open-label, non-randomized, Phase I, dose escalation/dose expansion study in cohorts of patients with relapsed, resistant, or metastatic HPV-associated cancers. The Expansion Phase will begin in parallel one dose level lower than the highest dose deemed safe in the Dose Escalation in combination with a PD-1 checkpoint blockade.


Eligibility criteria: Inclusion Criteria:

* Prior histologically confirmed HPV-associated squamous cell carcinoma, which is relapsed, resistant, or metastatic
* Life expectancy of at least 3 months
* Dose Escalation Phase: patients who have experienced disease progression on Standard of Care Therapies

Exclusion Criteria:

* Active CNS metastases
* Have any history of seizure disorder or are taking prophylactic seizure medication
* Have an active viral, bacterial, or fungal infection

Primary outcomes:
measure: Maximum Tolerated Dose
timeFrame: 12 months
Secondary outcomes:
measure: PK Parameters to determine the single dose
timeFrame: 30 days
measure: Steady state pharmacokinetics (PK) of TGN-S11
timeFrame: 30 days
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope
state: California
city: La Jolla
country: United States
facility: UCSD Moores Cancer Center
state: California
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: Chief Medical Officer
name: Neil J Clendeninn, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01095575: Pre- Versus Post-Incisional Epidural Morphine: Higher Postoperative Pain Perception and Extra Morphine Consumption
Official title: Pre- vs. Post-Incisional Epidural Morphine: Higher Postoperative Pain Perception and Extra Morphine Consumption
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: Epidural
Morphine
Preoperative
Postoperative
Analgesia
Tolerance
Preoperative, Postoperative Analgesia
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2010-03-30
Enrollment: 40
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background and Objectives: Neuraxial administration of morphine is an effective way of controlling postoperative pain and reducing analgesic consumption. Several animal models have demonstrated that preemptive administration of neuraxial narcotics reduced pain while others revealed the induction of post-incisional hypersensitivity. There have been no consistent results in clinical setting either. This double blind, randomized study compared the effects of PRE- vs. POST-incisional administration of neuraxial morphine on postoperative pain perception and analgesic requirements over 48 hours following laparotomy for open colectomy under standardized general anesthesia.

Methods: Twenty patients received epidural morphine (3 mg) pre-incision and saline after wound closure (MO1 group), and 20 patients received epidural saline before incision and morphine after wound closure (MO2 group). Postoperatively, all patients received boluses of morphine (1.5 mg) via intravenous patient-controlled analgesia (IV-PCA), and rescue doses of intramuscular diclofenac (75 mg) every 6 hours, as needed.


Eligibility criteria: Inclusion Criteria:

1.adults scheduled for elective laparotomy and colon surgery with the duration of surgery expected to last for at least 2 hours.

Exclusion Criteria:

1. allergy to morphine, fentanyl, non-steroidal anti-inflammatory drugs or any of the intraoperative anesthetic medications
2. use of opioids, sedatives or stimulants during 21 days prior to surgery, psychiatric illness
3. congestive heart failure, respiratory failure, neuromuscular disease or presence of a chronic pain syndrome
4. Pregnant women and patients unable to sign their own consent form

Primary outcomes:
measure: Subjective pain intensity, using a visual analogue scale (VAS) from 0 (no pain) to 10 (unbearable pain)
timeFrame: 48 hours
Secondary outcomes:
measure: Consumption of analgesics
timeFrame: 48 hours
Other outcomes:
Locations:
Study officials:
affiliation: Tel Aviv Medical Center
name: Avraham Weinbroum, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02043275: Effect of Resistance Training on Jump Landing Mechanics in Young Female Athletes
Official title: Effect of a Resistance Training Program on the Jump Landing Biomechanics of Young Female Athletes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anterior Cruciate Ligament Injury
Keywords: resistance training
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2014-01-23
Enrollment: 40
Sex: FEMALE
Minimum age (years): 10
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if jump landing mechanics in young female athletes can be improved with a resistance training intervention.

Detailed description: After initial baseline testing, athletes were randomly selected to receive upper body (control group) or lower body (intervention group) resistance training. Athletes attended supervised training sessions twice per week for 12 weeks, after which they were re-tested.

Eligibility criteria: Inclusion Criteria:

* at least one year experience playing organized sports

Exclusion Criteria:

* previous experience with resistance training
* any injury with a pain level of more than 3/10 on VAS
* any health condition that would preclude them from completing the training or testing
* previous experience using a Biodex dynamometer

Primary outcomes:
measure: Change in Landing Error Scoring System score from Baseline to 12 weeks.
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Neuromuscular power of the hip abductors measured by a Biodex isokinetic dynamometer
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Faculty of Kinesiology and Recreation Management
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Joanne L Parsons, PhD Cand.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Manitoba
name: Michelle M Porter, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01060475: Safety and Tolerability of LIM-0705 in Healthy Male Subjects
Official title: A Randomized, Double-Blind, Placebo-Controlled Phase 1 Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Exploratory Pharmacodynamics of LIM-0705 Given With or Without Tacrolimus in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Transplant
Lead sponsor: Limerick BioPharma
Sponsor class: INDUSTRY
First posted: 2010-02-02
Enrollment: 44
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: LIM-0705 dosed separately and in combination with tacrolimus will be safe and well tolerated.


Eligibility criteria: Inclusion Criteria:

* Male age 18-50
* Patient in good health as deemed by pre-study exam and history
* BMI 20-30 kg/sq. meter
* Absence of tremors
* Must be willing to remain in confinement for 17 days/16 nights
* Systolic BP 90-140 mmHg, diastolic BP 50-90 mmHg, resting HR 45-90 bpm
* Subject must be non-smoker or willing to abstain from smoking day -4 through day 30.
* Subject must abstain from alcohol, grapefruit,and caffeine-containing beverages starting Day -2 through Day 30.
* Subjects must use double-barrier contraception through course of study + 90 days following study

Exclusion Criteria:

* Allergy to red wine or onions
* Strict vegetarians
* Use of any non-study medication
* Use of chemotherapy within 5 years prior to Screening visit
* Use of any dietary aids
* Difficultly swallowing oral medications
* cognitive or psychiatric disorders

Primary outcomes:
measure: Safety and tolerability of LIM-0705 with and without co-administered drug (tacrolimus).
timeFrame: 14 days
Secondary outcomes:
measure: Pharmacokinetics of LIM-0705 with and without combination of co-administered drug (tacrolimus).
timeFrame: 14 days
Other outcomes:
Locations:
city: Heidelberg
country: Australia
facility: Nucleus Network CCS-Austin
state: Victoria
city: Prahran
country: Australia
facility: Nucleus Network CCS-AMREP
state: Victoria
Study officials:
affiliation: Nucleus Network
name: Albert Frauman, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06495775: Stool Sampling in the Acute Isolated Patient , Efficient Acquiring With a Novel Device
Official title: Stool Sampling in the Acute Isolated Patient, Efficient Acquiring With a Novel Device
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Feasibility Study
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
First posted: 2024-07-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: stool sample device tested on patients admitted to oncological dept. with diarrhea, in order to shorten time in isolation and time to relevant treatment.

Detailed description: the stool sample device will be tested on all patients admitted to an oncological dept. on Zealand University Hospital, with diarrhea, in order to examine if the the device is able to shorten time in isolation and time to relevant treatment.

Eligibility criteria: Inclusion Criteria:

* Understanding Danish
* admitted to dept og oncology with diarrhea
* cognitive intact
* Co operable to fecal sampling

Exclusion Criteria:

* expected survival less than 2 weeks

Primary outcomes:
measure: acquiring of stool sample with experimental device, in order to prove feasibility
timeFrame: the sample is intended to be collected in an expected time range is within 1-2 hours after admission
measure: safety of device
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Roskilde
country: Denmark
facility: Zealand University Hospital
state: Zealand Region
Study officials:
affiliation: Oncological department, Zealand University Hospital
name: Anne-Dorte b Krapper
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01311375: Omega 3 in Intervention Spinal Cord Injured People
Official title: Evaluation of Omega 3 Supplementation on Neurological Recovery , Lipid Profile and Antioxidant Enzymes and Hormones After Chronic Spinal Cord Injury.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Lipid Metabolism Disorders
Peroxidase; Defect
Keywords: spinal,, bone, cord injury, lipid,antioxidant
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2011-03-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The objective of this study is to evaluate the effect of omega 3 fatty acid on neurological recovery, lipid profile and Antioxidant system in patients with spinal cord injury. One hundred spinal cord injured patients who come to clinic of spinal injury repair research center selected. Then the patients will receive two supplements capsules of omega 3 (600 mg) in the intervention group and placebo in the control group. Primary outcome measures are professionals evaluation of neurological function by using :

* ASIA scale for sensory and motor function
* FIM scale for Functional potential
* FAM
* SF_36 for quality of life

Lipid profile and Antioxidant profile evaluation by using:

* FBS
* 2hpp
* Insulin
* LDL
* Total cHOL
* TG
* HDL
* Leptin Adiponectin -Calcium-
* 25OHD
* PTH,LH, FSH, Prolactin,Testosterone in males Bone markers by serum levels of :Osteocalcin-Osteoprotegrin_Bone Specified ALP- CTX - RANKL
* BMD

Detailed description: All no neurological evaluation will be done by experiment researcher under considering of a neurologist.All Sub clinical evaluation will be done by specific, sensitive and valid laboratory methods. Intervention time will be 14 months.Comparison of these variables will be done before and after intervention.

Eligibility criteria: Inclusion Criteria: no metabolic, malignant or kidney disorder, normal TSH, LH, FSH, prolactin, and testosterone in men and normal prolactin, estradiol, LH, FSH, and TSH in women

Exclusion Criteria:

* pregnancy, lactation, presence of bone disease,hypersensitivity to fish or fish oil, hypertension

Primary outcomes:
measure: Neurological recovery,metabolic profile and Antioxidant profile evaluation
timeFrame: 4 months
measure: Neurological recovery,metabolic profile and Antioxidant profile evaluation in SCI patients
timeFrame: 14 months
Secondary outcomes:
measure: Neurological recovery,metabolic profile and Antioxidant profile evaluation in patients with SCI
timeFrame: 14 months
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Brain and Spinal Injury Repair Research Center
Study officials:
affiliation: Brain and Spinal Cord Injury Repair Research Center
name: Abbas Nouroozi, Ph.D
role: STUDY_DIRECTOR
References:
Clinical trial NCT02443675: Observational Study of Pain Reduction in Late-Stage Cancer Patients Who Are Receiving Low-Dose Chemotherapy
Official title: Observational Study of Pain Reduction in Late-Stage Cancer Patients Who Are Receiving Low-Dose Chemotherapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Pain
Lead sponsor: Cure Cancer Worldwide, LLC
Sponsor class: INDUSTRY
First posted: 2015-05-14
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients Receiving Low Dose Chemotherapy

Brief summary: Observational Study of Pain Reduction in Late Stage Cancer Patients Receiving Low-Dose Chemotherapy

Detailed description: Observational Study of Pain Reduction in Late Stage Cancer Patients who are Receiving Low-Dose Chemotherapy (Metabolic Targeting)

Eligibility criteria: Inclusion Criteria:

* Patient requests to be included in this study

Exclusion Criteria:

* Patient does not request to be included in this study

Primary outcomes:
measure: Pain Level Self Assessment
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Cure Cancer Worldwide, LLC
name: gary l smith, mba
role: STUDY_DIRECTOR
References:
Clinical trial NCT02019459: Very Low Nicotine Cigarettes in Smokers With Schizophrenia
Official title: Very Low Nicotine Cigarettes in Smokers With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Tobacco Dependence
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: University of Pittsburgh
First posted: 2013-12-24
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Smokers with serious mental illness including those with schizophrenia and bipolar disorder infrequently attempt and attain sustained smoking abstinence and have a 25-year shorter lifespan due to smoking-related illness. This study will examine whether reducing the nicotine content of cigarettes to non-addicting levels is a viable method of reducing smoking in smokers with serious mental illness. Smokers will be randomized to one of two experimental conditions: 1) very low nicotine content (VLNC) cigarettes or 2) normal nicotine content (NNC) cigarettes. Participants will be assessed for patterns of tobacco use, biomarkers of exposure, subjective responses (e.g., satisfaction, craving, withdrawal symptoms), psychiatric symptoms, cognitive performance, smoking cue reactivity and smoking topography.


Eligibility criteria: Inclusion Criteria:

* Age 18-70
* Schizophrenia, schizoaffective disorder or bipolar disorder
* Smoke an average of at least 10 cigarettes per day for at least 1 year
* Breath carbon monoxide (CO) levels \>8 ppm (if ≤ 8 ppm, then nicotine (NicAlert) Strip \> 2)

Exclusion Criteria:

* Pregnant or nursing
* Seeking treatment for smoking
* Medical contraindications

Primary outcomes:
measure: Number of cigarettes smoked per day
timeFrame: End of 6 week intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Providence
country: United States
facility: Brown University
state: Rhode Island
Study officials:
affiliation: Brown University
name: Jennifer Tidey, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: