louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00467454: Naltrexone in the Treatment of Pyromania
Official title: A Double-Blind, Placebo-Controlled Study of Naltrexone in Pyromania
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Pyromania
Keywords: Pyromania
Fire Setting
Compulsive Fire Setting
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2007-04-30
Enrollment: 0
Sex: ALL
Minimum age (years): 16
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The proposed study will consist of 8 weeks of treatment with either naltrexone or placebo in 10 subjects with pyromania.

Detailed description: The goal of the proposed study is to evaluate the efficacy and safety of naltrexone in pyromania. Ten subjects with DSM-IV pyromania will receive 8 weeks of naltrexone or placebo. The hypothesis to be tested is that naltrexone will be effective in reducing the urges to set fires patients with pyromania. The proposed study will provide needed data on the treatment of a disabling disorder that currently lacks a clearly effective treatment.

Eligibility criteria: Inclusion Criteria:

1. men and women age 16-75;
2. current DSM-IV pyromania

Exclusion Criteria:

1. unstable medical illness or clinically significant abnormalities on prestudy laboratory tests or physical examination;
2. history of seizures;
3. myocardial infarction within 6 months;
4. current pregnancy or lactation, or inadequate contraception in women of childbearing potential;
5. clinically significant suicidality;
6. current or recent (past 3 months) DSM-IV substance abuse or dependence;
7. illegal substance within 2 weeks of study initiation;
8. initiation of psychotherapy or behavior therapy from a mental health professional within 3 months prior to study baseline;
9. initiation of a psychotropic medication within 2 months prior to study inclusion;
10. previous treatment with naltrexone; and
11. treatment with investigational medication or depot neuroleptics within 3 months, with fluoxetine within 6 weeks, or with other psychotropics within 2 weeks prior to study baseline

Primary outcomes:
measure: Yale Brown Obsessive Compulsive Scale Modified for Pyromania (P-YBOCS)
timeFrame: At each visit
Secondary outcomes:
measure: Pyromania Symptom Assessment Scale (P-SAS); Sheehan Disability Inventory
timeFrame: At each visit
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Jon E Grant, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02041754: Safety and Efficacy of IQP-AK-102 in Reducing Appetite
Official title: Double Blind, Randomized, Placebo-controlled, Monocentric Clinical Investigation to Evaluate Efficacy of IQP-AK-102 on Appetite Reduction in Healthy Overweight and Obese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Weight Loss
Appetite Modulation (Focus of Study)
Lead sponsor: InQpharm Group
Sponsor class: INDUSTRY
First posted: 2014-01-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The individual ingredients in IQP-AK-102 have been widely used. Backed by data from several studies demonstrating their efficacy, we are conducting this study to look into the efficacy and safety of this novel combination of three fibres, in appetite regulation, aiming to reduce the appetite.


Eligibility criteria: Inclusion Criteria:

* Age 18 to 65 years
* 25≤BMI≤35
* Expressed desire for weight loss
* Accustomed to 3 main meals/day
* Generally in good health
* Consistent and stable body weight 3 months prior to study enrolment
* Consistent regular physical activity
* Commitment to avoid the use of other weight loss products during study
* Commitment to adhere to diet and lifestyle recommended for the study

Exclusion Criteria:

* Known sensitivity to the ingredients of the device
* Presence of any active gastrointestinal disease
* Malabsorption disorders
* Pancreatitis
* Stenosis in the GI tract
* Bariatric surgery
* Any other reason deemed suitable for exclusion, per investigator's judgement

Primary outcomes:
measure: Difference of VAS between two study arms measured from time '0 to '240 during baseline visit and the final visit
timeFrame: 4 weeks
Secondary outcomes:
measure: Difference in ad libitum energy intake between the two arms at baseline visit and at final visit
timeFrame: 4 weeks
measure: Change in "difference in ad libitum energy intake between two study arms", from baseline visit to the final visit
timeFrame: 4 weeks
measure: Difference in subjective appetite sensations (VAS) between baseline and the final visit for the two study arms
timeFrame: 4 weeks
measure: Difference in the mean change in body weight between the 2 arms, from baseline to the final visit
timeFrame: 4 weeks
measure: Changes in waist and hip circumference
timeFrame: 4 weeks
measure: Changes in body fat content and fat free mass
timeFrame: 4 weeks
measure: Subjects global feeling of satiety
timeFrame: 4 weeks
measure: Food Craving Questionnaire
timeFrame: 4 weeks
measure: Global evaluation of efficacy by the subjects and investigators
timeFrame: 4 weeks
measure: Global evaluation of safety by the subjects and investigators
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Udo Bongartz
Study officials:
affiliation: Analyze & Realize
name: Udo Bongartz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00997854: Preterm Neonatal Feeding Protocol Comparing Feed Administration Time
Official title: Preterm Neonatal Feeding Protocol Comparing Feed Administration Time
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Feeding Intolerance
Keywords: Feeding
Intolerance
Preterm
Bolus
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2009-10-19
Enrollment: 136
Sex: ALL
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Doctors have tried many different methods of feeding to try to decrease feeding intolerance in preterm babies so that they spend less time receiving liquid nutrition and have fewer problems with feeding intolerance.

The purpose of this study is to test two different methods of feeding preterm babies in the hopes of identifying a method that will decrease some of the feeding intolerance that can occur when feeding premature babies.


Eligibility criteria: Inclusion Criteria:

* Any infant born at OHSU or transferred in from another facility whose birthweight is greater than 500 grams and less than 1500 grams, and whose gestational age is less than 32 weeks.

Exclusion Criteria:

* Any infant who has major anomalies including but not limited to \*gastroschisis

  * omphalocele
  * bowel obstruction or atresia
  * tracheo-esophageal fistula
  * Hirschsprung's Disease
  * congenital diaphragmatic hernia
  * congenital heart disease and other major syndromes
  * infants who have started enteral feeds prior to entering the study
* Any infant whose birth weight is greater than or equal to 1500 grams or less than 500 grams
* Any infant whose gestational age is greater than 32 weeks.

Primary outcomes:
measure: To compare feeding intolerance between these two groups as defined by the following criteria: the number of times that the signs and symptoms in an infant caused the perception of feeding intolerance with feeds paused for longer than one feeding.
timeFrame: Daily
Secondary outcomes:
measure: To compare the number of days it takes the infant to reach full feeds.
timeFrame: After reaching full feeds.
measure: To compare the number of days the infant requires intravenous nutrition.
timeFrame: After reaching full feeds.
measure: To compare the number of days of overall hospitalization duration.
timeFrame: After patient discharge.
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Sciences University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Sue Ann Smith, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06674954: Comparison of Perioperative Characteristics of Regional Anasthesia and General Anesthesia
Official title: Comparison of Perioperative Characteristics of Regional Anasthesia and General Anesthesia in Shoulder Arthroscopy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Shoulder Arthroscopy
Peripheral Nerve Block
Keywords: Shoulder Arthroscopy
General Anesthesia
Regional Anesthesia
Lead sponsor: Ankara Etlik City Hospital
Sponsor class: OTHER_GOV
First posted: 2024-11-05
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Shoulder arthroscopy is one of the most common surgical procedures performed today.It is important to perform the surgical procedure under regional anesthesia to prevent intraoperative complications due to general anesthesia.After shoulder surgery, providing adequate analgesia is necessary for both the comfort of the patient and the ability to perform the necessary post-operative rehabilitation exercises early and regularly.

Nerve blocks reduces opioid consumption in the postoperative period by providing better pain control and therefore has advantages such as fewer side effects and less risk of pulmonary and cardiac complications.

In this study; it was aimed to compare postoperative pain scores, patient satisfaction and surgeon satisfaction in patients who were operated under general anesthesia or who underwent shoulder arthroscopy while awake under regional anesthesia


Eligibility criteria: Inclusion Criteria:

* Patients aged 18-80 years
* American Society of Anesthesiologists (ASA) score I-II-III
* Body Mass Index (BMI) between 18-30 kg/m2

Exclusion Criteria:

* Patients under 18 and over 80 years of age
* ASA score IV and above
* BMI below 18 or above 30 kg/m2

Primary outcomes:
measure: Pain Scores
timeFrame: At the 0st, 1st, 2nd,4th, 12th, and 24th hours after the surgery.
Secondary outcomes:
measure: Patient satisfaction
timeFrame: Up to 24 hours after surgery
measure: Surgeon satisfaction
timeFrame: Up to 24 hours after surgery
measure: Duration of the surgery
timeFrame: During surgery
measure: Intraoperatif opioid consumption
timeFrame: During surgery
Other outcomes:
Locations:
city: Altındağ
country: Turkey
facility: Ankara Etlik City Hospital
state: Ankara
Study officials:
References:
Clinical trial NCT01806454: Calcium Supplementation to Prevent Preeclampsia in Sichuan Province of China
Official title: Calcium Supplementation to Prevent Preeclampsia in Sichuan Province of China: a Multi-center, Prospective Random Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Preeclampsia
Lead sponsor: West China Second University Hospital
Sponsor class: OTHER
Collaborators: name: Sichuan Academy of Medical Sciences
name: Guang'an people's hospital of Sichuan province
name: pengzhou shi fuyou baojianyuan
name: The First People's Hospital of Neijiang
name: Suining Central Hospital
name: Sichuan Provincial Maternal and Child Health Care Hospital
name: Chengdu Women's and Children's Central Hospital
First posted: 2013-03-07
Enrollment: 11000
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: the purpose of this study is to determine whether calcium supplementation is effective to prevent preeclampsia in Sichuang Province of china and which dose is more suitable


Eligibility criteria: Inclusion Criteria:

* Nulliparity;age ≥35 years;Previous pre-eclampsia;Family history of pre-eclampsia;Multiple pregnancy;Time between pregnancies ≥10years;Body mass index ≥25;diastolic pressure ≥ 80 mm Hg before 20 weeks' gestation;Proteinuria ≥+ on more than one occasion or ≥ 300 mg/24 h before 20 weeks' gestation;Underlying medical conditions(Pre-existing hypertension;Pre-existing renal disease;Pre-existing diabetes;Presence of antiphospholipid antibodies;Chronic autoimmune disease);male sex partner's predecessor wife has Previous pre-eclampsia

Exclusion Criteria:

* first prenatal visit after 16 weeks' gestation;severe anemia;other Underlying medical conditions which need treatment first (such as uncontrolled hyperthyreosis )

Primary outcomes:
measure: incidence of pre-eclampsia
timeFrame: postpartum forty-two days
Secondary outcomes:
Other outcomes:
Locations:
city: Chengdu
country: China
Study officials:
References:
Clinical trial NCT00975754: Lung Deposition Via Different Inhalation Devices
Official title: A Phase I, Randomized, Open-label, 5-way Crossover, Single Centre Study in Healthy Subjects to Assess the Lung Deposition of Inhaled Budesonide Delivered Via Different Inhalation Devices
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Inhalation
lung deposition
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-09-11
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to assess the deposition of budesonide to the lung after inhalation with 5 different devices and to relate the findings to in vitro properties of inhaled budesonide.


Eligibility criteria: Inclusion Criteria:

* Provision of informed consent prior to any study specific procedures
* BMI between 18 and 30 kg/m2
* Non-smokers/non-snuffers

Exclusion Criteria:

* Pregnant and/or lactating women
* Use of oral contraceptives or hormonal implants
* Known or suspected hypersensitivity to glucocorticosteroids, inhaled lactose, or other excipients in study drugs

Primary outcomes:
measure: Lung deposition of budesonide (AUC)
timeFrame: Before dose and repeatadly during the 8-hour period after dose
Secondary outcomes:
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Research Site
Study officials:
affiliation: AstraZeneca R&D Lund, Sweden
name: Carin Jorup
role: STUDY_DIRECTOR
affiliation: Clinical Pharmacology Unit, AstraZeneca R&D Lund, Sweden
name: Pia Lena Berg
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03916354: Maternal Gestational Weight Gain and Microbiota of Maternal and Infant
Official title: Clinical Study of the Effect of Gestational Weight Gain on Composition of Gut Microbiome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pregnancy
Gestational Weight Gain
Microbiota
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2019-04-16
Enrollment: 550
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: About 550 pregnant women meeting the conditions will be recruited from April 2019 to December 2019 during their routine antenatal caer at the first visit.

Brief summary: A prospective, multicenter, observational cohort study including about 550 mother-infant pairs in Beijing will be conducted to evaluate the association between mothers' gestational weight gain and the gut microbiota of them and their infants.

Detailed description: Purpose To evaluate whether mothers' gestational weight gain is associated with differences in maternal and their infants gut microbiota characteristics.

Methods and analysis This is a prospective, multicenter, observational cohort study including about 550 mother-infant pairs from PUMCH and other 3 hospitals in Beijing. After signing consent form, every participant will bring home a weighting scale for checking and record the weight every week from they enrolled to a year postpartum. The blood samples, fecal samples, vaginal swabs and oral swabs of the mothers will be collected at first, second, third trimester and postpartum 42 days. The infants' fecal samples will be collected at 0\~3, 14, 42 days and 3, 6, 9, 12 months after born. Questionnaire for mothers (diet, exercise, antibiotic and probiotic usage, oral hygiene habits etc.) and their infants (delivery mode, feeding pattern, antibiotic and probiotic usage etc.), as well as the medical records will be collected along with the sample collecting. Bio-specimen will be tested by 16S rRNA gene sequencing. Logistical regression and covariance analysis will be used to determine the relationships between the demographic data, gestational weight gain and microbiota composition.

Eligibility criteria: Inclusion Criteria:

* Ensure a regular prenatal check in the clinical centers.
* 20-45 years old.
* 8-13 gestational weeks.
* Singleton.
* Fully understand and voluntarily sign the informed consent.

Exclusion Criteria:

* IUI or IVF-ET pregnancy.
* Smoking or drinking.
* Antibiotics exposure within a month.
* With metabolic syndrome, hypertension, diabetes or dyslipidemia before pregnancy.
* With digestive disease, uncontrolled thyroid disease.

Primary outcomes:
measure: maternal gut microbiota, vaginal microbiota, oral microbiota
timeFrame: From enrollment to 42 days postpartum
measure: gut microbiota infants
timeFrame: From delivery to 1 year postpartum.
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Medical Univercity College Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT00215254: Quetiapine in Social Anxiety Disorder
Official title: A Randomized, Double-Blind, Placebo-Controlled Pilot Study of Quetiapine in Social Anxiety Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Social Anxiety Disorder
Keywords: quetiapine
social anxiety disorder
antipsychotic
pilot study
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2005-09-22
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to examine the effectiveness and tolerability of quetiapine for the treatment of social anxiety disorder (SAD). The hypothesis is that quetiapine will be effective and well-tolerated for patients with social anxiety disorder.

Detailed description: This is an eight week, randomized, double-blind, placebo-controlled trial of quetiapine (100-400 mg/day)in social anxiety disorder.

Eligibility criteria: Inclusion Criteria:

* adult outpatients 18-65 years of age
* primary diagnosis of social anxiety disorder, using DSM-IV criteria
* minimum CGI severity score of 4 at baseline
* minimum BSPS score of 20 at baseline
* written informed consent
* negative serum pregnancy test for women of childbearing potential

Exclusion Criteria:

* current DSM-IV diagnosis of bipolar disorder, schizophrenia or other psychotic disorder, or cognitive disorder due to a general medical condition
* any current primary anxiety disorder other than SAD or current primary depression
* history of substance abuse or dependence with the last 6 months
* suicide risk or serious suicide attempt within the last year
* clinically significant medical condition or laboratory abnormality
* women of childbearing potential who are unwilling to practice an acceptable method of contraception
* concomitant medication use for psychotropic purposes
* history of hypersensitivity to quetiapine

Primary outcomes:
measure: Brief Social Phobia Scale (BSPS)
Secondary outcomes:
measure: Clinical Global Impressions of Severity (CGI-S)
measure: Clinical Global Impressions of Improvement (CGI-I)
measure: Social Phobia Inventory (SPIN)
measure: Hospital Anxiety and Depression Scale (HADS)
measure: Connor Davidson Resilience Scale (CD-RISC)
measure: Sheehan Disability Inventory (SDI)
measure: Barnes Akathisis Scale (BAS)
measure: Simpson-Angus Scale (SAS)
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Jonathan Davidson, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03001154: Virtual Reality Exposure Therapy for Speech Anxiety Using Commercial Hardware and Software
Official title: Virtual Reality Exposure Therapy for Speech Anxiety Using Commercial Hardware and Software
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Social Phobia
Anxiety
Behavior Therapy
Lead sponsor: Stockholm University
Sponsor class: OTHER
First posted: 2016-12-22
Enrollment: 50
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: Virtual Reality Exposure Therapy (VRET) is an efficacious treatment of fear and anxiety, but because of the high financial costs and technical complexity of the past generation of VR hardware, there has been no large-scale implementation of this promising treatment. The present study will investigate whether off-the-shelf, commercial VR hardware and software can be used as stimuli material to conduct in-session exposure therapy for speech anxiety. The study will recruit n=25+25 participants from the general public suffering from substantial speech anxiety, who will be randomized to either a waiting-list, or one-session VRET with a therapist, followed by four weeks of a progressive maintenance program encouraging in-vivo exposure. The waiting-list group will then receive an Internet-delivered VRET treatment program.


Eligibility criteria: Inclusion Criteria:

* Substantial public speaking anxiety
* Have access to VR-compatible smartphone (including Internet)
* Can travel to Stockholm University for treatment on one occasion
* Can speak and understand sufficient Swedish

Exclusion Criteria:

* Deficits in sight or balance impacting the VR-experience
* A severe psychiatric disorder better treated elsewhere, including current major depression, alcohol or drug abuse, bipolarity, psychosis or similar
* Active psychopharmacological treatment, unless stable for last 3 months
* Other ongoing psychological treatment

Primary outcomes:
measure: Public Speaking Anxiety Scale
timeFrame: Change from baseline: Week 0, 1, 2, 3, 4, 5 and 21
Secondary outcomes:
measure: Liebowitz Social Anxiety Scale Self-Report
timeFrame: Change from baseline: Week 0, 5 and 21
measure: Brief Fear of Negative Evaluation Scale
timeFrame: Change from baseline: Week 0, 5 and 21
measure: Patient Health Questionnaire 9-item
timeFrame: Change from baseline: Week 0, 5 and 21
measure: Generalized Anxiety Disorder 7-item
timeFrame: Change from baseline: Week 0, 5 and 21
measure: Brunnsviken Brief Quality of life scale
timeFrame: Change from baseline: Week 0, 5 and 21
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Department of Psychology
Study officials:
References: