louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01685957: Optimal Dietary Treatment of Obese Adults
Official title: Optimal Dietary Treatment of Obese Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Overweight
Keywords: Weight loss
Dietary intervention
Self-help book
Cooking
Dietitian
Dietary therapy
Lead sponsor: Hospitalsenheden Vest
Sponsor class: OTHER
First posted: 2012-09-14
Enrollment: 120
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: Recent decades have shown an alarming increase in obesity. Obesity is associated with high costs for both the individual and for society. It is therefore important to prevent and treat obesity. The investigators believe that if you add a self-help weightloss book and teach cooking skills to a standard dietary treatment, then it will result in greater weight loss than with dietary treatment alone. However, this has not yet been studied. Since it will require more resources, it is important to investigate whether it also works better before changing the current treatment.

Hypothesis: Conventional dietary treatment supplemented with a self-help weightloss book and cooking classes are more effective than dietary treatment alone in changes in body weight and body composition in obese persons over a period of 12 months. There is no difference if the intervention are based on the national dietary guidelines or a relative low-gi and high-protein diet.

Secondary to investigate the impact the interventions have; on diet quality and quantity, on markers of metabolic syndrome and on how many subjects complete the study.


Eligibility criteria: Inclusion Criteria:

* BMI ≥ 25
* Waist: female ≥ 88 cm; male ≥ 102 cm)
* Stable weight for the past three month (+- 5 kilogram)
* Motivated to make changes in their dietary habits

Exclusion Criteria:

* Waist \> 150 cm
* Significant cardiovascular, renal or endocrine disease
* Psychiatric history
* Treatment with steroids
* Alcohol- or drug-addiction
* Pregnancy or lactation
* Obesity surgery

Primary outcomes:
measure: Body weight
timeFrame: From week 0 to week 52
Secondary outcomes:
measure: Blood pressure
timeFrame: From week 0 to week 52
measure: Dexa-scan (body composition)
timeFrame: From week 0 to week 52
measure: Waist circumference
timeFrame: From week 0 to week 52
measure: Biomarkers in blood samples
timeFrame: From week 0 to week 52
measure: Quality of life
timeFrame: From week 0 to week 52
measure: Dietary intake
timeFrame: From week 0 to week 52
Other outcomes:
Locations:
city: Holstebro
country: Denmark
facility: Department of Nutrition, Regional Hospital West Jutland, Denmark
Study officials:
affiliation: Department of Nutrition, Regional Hospital West Jutland, Denmark
name: Allan S Christensen, MHSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Nutrition, Regional Hospital West Jutland, Denmark
name: Lone Viggers, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01251848: Drug Interaction Between Ritonavir And Sitaxsentan
Official title: A Phase 1, Open Label, Randomized, Multiple Dose Study To Assess The Two-Way Drug Interaction Between Sitaxsentan And Low Dose Ritonavir In Healthy Subjects
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Pulmonary Arterial Hypertension
Keywords: Sitaxentan
ritonavir
drug interaction
pharmacokinetics
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-12-02
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The study is to assess if sitaxsentan and ritonavir will affect the blood levels of each other when coadministered.


Eligibility criteria: Inclusion Criteria:

* Healthy male subjects and/or women of non-child bearing potential.
* Subjects (because of teratogenic risk of sitaxsentan) between the ages of 21 and 55 years, inclusive.
* Signed informed consent.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
* History of significant alcohol and drug use.
* Has hepatic dysfunction.

Primary outcomes:
measure: The comparison of peak plasma concentration of sitaxsentan when coadministered with ritonavir versus sitaxsentan administered alone.
timeFrame: 24 hours
measure: The comparison of area under the curve of sitaxsentan when coadministered with ritonavir versus sitaxsentan administered alone.
timeFrame: 24 hours
measure: The comparison of peak plasma concentration of ritonavir when coadministered with sitaxsentan versus ritonavir administered alone.
timeFrame: 24 hours
measure: The comparison of area under the curve of ritonavir when coadministered with sitaxsentan versus ritonavir administered alone.
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01019148: Characteristics of Patients With Recessive Dystrophic Epidermolysis Bullosa
Official title: Characteristics of Patients With Recessive Dystrophic Epidermolysis Bullosa
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Epidermolysis Bullosa Dystrophica
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2009-11-25
Enrollment: 70
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with RDEB by a local dermatologist who are medically stable enough to travel to Stanford University Medical Center. Patients should also be at least 7 years of age.

Brief summary: Recessive dystrophic epidermolysis bullosa (RDEB) is a disease caused by genetic mutations in the gene for type VII collagen. Patients with RDEB develop large, severely painful blisters and open wounds from minor trauma to their skin. We are screening subjects with RDEB to evaluate characteristics of the subjects and their cells in order to develop new strategies of therapy and determine whether subjects could be candidates for treatment studies.

Detailed description: We will obtain a detailed medical history and will perform a skin examination and brief physical exam. Photographs may be taken. We will ask questions about the size and duration wounds.

LAB TESTS We will draw blood to determine overall health status to include Hepatitis B, Hepatitis C, and Human Immunodeficiency Virus (HIV) testing. Genetic testing may also be performed.

BIOPSIES Biopsies may be collected to check for Collagen 7 and for antibodies to Collagen 7.

Based on the results obtained, it may be possible to identify patients who would qualify to participate in current or future clinical trials.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of RDEB by local dermatologist
* 7 years of age or older

Exclusion Criteria:

-Medical instability limiting ability to travel to Stanford University Medical Center

Primary outcomes:
measure: Identification of subjects with Recessive Dystrophic Epidermolysis Bullosa
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Jean Tang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06198348: Aerobic Training With and Without Resistance Training in Polycystic Ovarian Syndrome
Official title: Effects of Aerobic Training With and Without Resistance Training on Waist to Hip Ratio, Quality of Life and Menstrual Dysfunction in Polycystic Ovarian Syndrome.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polycystic Ovary Syndrome
Keywords: Polycystic ovarian syndrome
Quality of life
Waist to Hip Ratio
Aerobic Exercise
Resistance Training
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-01-10
Enrollment: 22
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Polycystic ovary syndrome (PCOS) characterized by a chronic disorder in ovulation along with hyperandrogenism has become one of the most common endocrine disorders in women of reproductive age with an estimated 5%-15% prevalence. It has the symptoms such as menstrual disorders, infertility, hyperandrogenism, obesity, hirsutism and acne. PCOS is linked to Psychological morbidities e.g. increased risk of stress, depression, low self-esteem, poor body image, and reduced health-related quality of life. Approximately 75% of people with PCOS have a fat accumulation in the central area of the body.

Detailed description: A Randomized controlled trial will be conducted to determine the effects of Aerobic training with and without resistance training on the waist to hip ratio, QoL and menstrual dysfunction in polycystic ovarian syndrome. A sample size of 22 PCOS women's will be taken, Data will be collected from Jinnah Hospital Lahore by using PCOSQ and SF-36 questionnaire. A written consent form will be taken from participants meeting inclusion criteria and will be randomly allocated into two groups of equal members. One group undergoing aerobic with resistance exercise training i.e., the experimental group and other with aerobic exercise i.e., control group. The interventions will be provided for 30 mints for 3 days per week for 2 months. All participants in both groups will be evaluated before and after the treatment programs.

Eligibility criteria: Inclusion Criteria:

* Age 18-40yrs
* Waist to hip ratio \>87(20)
* Women who are diagnosed according to Rotterdam criteria e.g. oligo/anovulation, hyperandrogenism, and polycystic ovaries.(21)
* Female who physically able to performs exercise

Exclusion Criteria:

* Women who are smoking and using drugs for depression.
* Married women
* Women with other pathological conditions like diabetes and thyroid diseases.
* Females who are not able to perform resistant exercise

Primary outcomes:
measure: SF-36 Questionnaire
timeFrame: 8 weeks
measure: Self-administered PCOSQ
timeFrame: 8 weeks
measure: Measuring Tape
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Jinnah Hospital
state: Punjab
Study officials:
affiliation: Riphah International University, Senior Lecturer
name: Faiza Taufiq, PPDPT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00288548: Metoprolol and Formoterol in Chronic Obstructive Pulmonary Disease (COPD)
Official title: Pulmonary Effects of the Combination of Metoprolol and Formoterol in COPD
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Lead sponsor: Martini Hospital Groningen
Sponsor class: OTHER
First posted: 2006-02-08
Enrollment: 45
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: We want to study the effect of the combination of metoprolol (a beta-blocker) with formoterol (a beta-agonist) on long function in patients with Chronic Obstructive Pulmonary Disease (COPD). There are more and more clues that a beta-blocker, when well chosen and in the right dosage, won't harm the long function in patients with COPD. Since a beta-blocker can be a valuable addition to treating patients with heart problems we would like to see if this category of medication can be available for COPD patients in the future.


Eligibility criteria: Inclusion Criteria:

* male/female aged between 40-70 inclusive
* COPD defined by GOLD criteria
* FEV1 greater or equal to 60% of predicted without medication
* baseline FEV1 greater or equal than 1.2L
* 10 or more pack years
* no hard contraindications for use of beta blockers
* being able to perform technically acceptable pulmonary function tests
* signed informed consent
* systolic blood pressure equal to 130 or greater

Exclusion Criteria:

* instable COPD during the month before visit 1
* usage of corticosteroids during the month before visit 1
* significant pulmonary diseases other than COPD
* a history of cancer within the last 5 years (basal cell carcinoma or cutaneous squamous cell carcinoma allowed)
* a recent history of myocardial infarction
* use of an investigational drug within one month or six half lives (which ever is greater) of visit 1
* contra-indications for the use of ipratropium-bromide

Primary outcomes:
measure: Difference in airway reactivity after treatment with metoprolol compared to placebo.
Secondary outcomes:
measure: Effect of formoterol on airway reactivity comparing metoprolol with placebo.
measure: Borg-scores during provocation test
measure: Peak-flow measurements
measure: CCQ-scores
measure: Exacerbation rate and rescue medication use
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: Martini Hospital
Study officials:
affiliation: Martini Hospital Groningen
name: René Aalbers, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00352248: Randomized Controlled Trial of Acupuncture Versus Sham Acupuncture in Autistic Spectrum Disorder
Official title: Randomized Controlled Trial of Acupuncture Versus Sham Acupuncture in Autistic Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Autistic Disorder
Autism
Keywords: Alternative Medicine (AM)
Traditional Chinese Medicine
Tongue Acupuncture
Autistic Spectrum Disorder
Autism
Children
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2006-07-14
Enrollment: 50
Sex: ALL
Minimum age (years): 3
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: We aim to study the efficacy of Acupuncture versus sham acupuncture in children with ASD.

Detailed description: In Traditional Chinese Medicine (TCM) philosophy, the approach to Autistic Spectrum Disorder (ASD) is a holistic one. The objective is to study the efficacy of a short intensive course of Acupuncture versus sham acupuncture in improving the overall functional status of children with autism. A single-blind randomized control trial was conducted in 50 children. These children were randomly assigned to Treatment group with Tongue Acupuncture (40 sessions over 8 weeks) or Control group (Sham Tongue Acupuncture to non-acupoints in the tongue).

Eligibility criteria: Inclusion Criteria:

* Subjects with diagnosis of autism made according to the criteria of the 4th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) and Autism Diagnostic Interview-Revised and with a score for Childhood Autism Rating Scale (CARS) greater than 30.

Exclusion Criteria:

* Children with associated neurological disorders and epilepsy.

Primary outcomes:
measure: Griffiths Mental Developmental Scale (GMDS) was conducted before (at Week 0) and after (at Week 9) acupuncture.
measure: Ritvo-Freeman Real Life Scale (RFRLS) was conducted before (at Week 0) and after (at Week 9) acupuncture.
measure: Reynell Language Developmental Scale (RLDS) was conducted before (at Week 0) and after (at Week 9) acupuncture.
measure: Symbolic Play Test (SPT) was conducted before (at Week 0) and after (at Week 9) acupuncture.
measure: Functional Independence Measure for children (WeeFIM) was conducted before (at Week 0) and after (at Week 9) acupuncture.
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Duchess of Kent of Children Hospital
Study officials:
affiliation: The University of Hong Kong
name: Wong Virginia
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05660148: Influence of Resentment and Forgivingness on Quality of Life in People Living With HIV
Official title: Influence of Resentment and Forgivingness on Quality of Life in People Living With HIV
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Forgiveness
Hiv
Stress
Stigma
Health
Keywords: Forgiveness
forgivingness
Hiv
Stress
stigma
health
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2022-12-21
Enrollment: 206
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients living with HIV (PLHIV) are patients particularly exposed to stress, not only because of their chronic pathology but also because of the stigma attached to this disease.Patients belonging to the PLHIV followed at the Amiens University Hospital, not likely to move within the year

Brief summary: Life stress is strongly associated with poor mental and physical health and its effects explain significant morbidity and mortality. Forgiveness is one of the factors that can influence the effects of stress on health. By definition, forgiveness is the release of negative feelings, emotions, and behaviors - and possibly the release of positive feelings - toward an offender. Numerous studies have shown that forgiveness is associated with several mental and physical health benefits. The literature argues that high levels of propensity to forgive (trait) predispose that person to experience forgiveness (state) more often. In other words, a stronger forgiving disposition is believed to increase the experience of forgiveness, which, in turn, mitigates the negative effects of stress. Forgiveness is therefore a coping style that can play a beneficial role in the stress-health relationship. Patients living with HIV (PLHIV) are patients particularly exposed to stress, not only because of their chronic pathology but also because of the stigma attached to this disease. Very few studies have studied the impact of forgiveness (state or trait) on the physical health of PLHIV and even fewer the impact of an intervention promoting the disposition to forgive. The objective of this prospective observational monocentric study is to show in a very secular country that forgiveness has an effect on well-being as well as on other health parameters.


Eligibility criteria: Inclusion Criteria:

* Belonging to the PLHIV followed at the Amiens University Hospital, not likely to move within the year
* Possibility of follow-up in teleconsultation (usual support of the service)
* Benefiting from a social security scheme
* Consent to participate in the research

Exclusion Criteria:

* Erratic follow-up (non-compliance, predictable move) or moribund patient
* Illiterate or not speaking french

Primary outcomes:
measure: establishment of correlation between the inclination to forgiveness and the quality of life
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
References:
Clinical trial NCT00711048: Esophageal Hypersensitivity Study in Healthy Volunteers
Official title: A Phase I, Two Centre, Double-blind, Randomized, Cross-over Study to Evaluate AZD1386 in Single Doses of 30 mg and 95 mg Compared to Placebo in a Multimodal Experimental Pain Model on Esophageal Sensitivity and Development of Sensitization in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pain
Esophageal Sensitivity
Keywords: GERD
healthy volunteer
esophagus
pain
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-07-08
Enrollment: 45
Sex: MALE
Minimum age (years): 20
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 the study is to compare sensitivity and sensitization of visceral pain in the esophagus using different pain stimuli


Eligibility criteria: Inclusion Criteria:

* Provision of written consent
* Clinically normal physical findings
* Sensitization potential

Exclusion Criteria:

* Clinically significant illness within 2 weeks prior to the first dose of investigational product
* History of clinically significant disease
* Use of prescribed medication during the 2 weeks before administration of the first dose of investigational product

Primary outcomes:
measure: VAS scale and clock
timeFrame: Several occasions during the study days
Secondary outcomes:
measure: VAS scale and pressure, VAS scale and current, VAS scale and acid volume
timeFrame: Several occasions during the study days
measure: Pharmacokinetic variables
timeFrame: Several occasions during the study days
measure: Safety variables (adverse events, blood pressure, safety lab, ECG and body temperature)
timeFrame: Several occasions during the study days
Other outcomes:
Locations:
city: Arhus
country: Denmark
facility: Research Site
city: Goteborg
country: Sweden
facility: Research Site
Study officials:
affiliation: AstraZeneca R&D, Mölndal, Sweden
name: Marie Sundin
role: STUDY_DIRECTOR
affiliation: Aarhus University Hospital, Dept of Surgical Gastroenterology, Aarhus, Denmark
name: Peter Funch-Jensen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Krarup AL, Ny L, Astrand M, Bajor A, Hvid-Jensen F, Hansen MB, Simren M, Funch-Jensen P, Drewes AM. Randomised clinical trial: the efficacy of a transient receptor potential vanilloid 1 antagonist AZD1386 in human oesophageal pain. Aliment Pharmacol Ther. 2011 May;33(10):1113-22. doi: 10.1111/j.1365-2036.2011.04629.x. Epub 2011 Mar 16.
Clinical trial NCT00135148: Decrease of Libido of Post-Operative Male-Female Transsexuals and a Healthy Female Control Group
Official title: Decrease of Libido of Post-Operative Male-Female Transsexuals and a Healthy Female Control Group
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Transsexualism
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: Organon
First posted: 2005-08-25
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: Participants fill out a questionnaire on libido and their possible partner relationship.

A blood sample is taken for sex steroid analysis.

Detailed description: Participants fill out a questionnaire on libido and their possible partner relationship on the website http://www.onderzoek-libido.be.

A blood sample is taken for sex steroid analysis. The relation will be investigated between testosterone, free testosterone, sex hormone binding globulin, estradiol, DHEA and androstenedione and scores on relational and sexual satisfaction and sexual desire.

Eligibility criteria: Inclusion Criteria:

* Transsexual women with completed adaptation of the sex (all surgical procedures and hormonal treatments)
* The female control group must be 18-45 years

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Guy T'Sjoen, MD
role: PRINCIPAL_INVESTIGATOR
References: