louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00633347: Use of Antagonist Versus Agonist GnRH in Oocyte Recipient Endometrium Preparation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Infertility
Keywords: oocyte donation
endometrial preparation
Lead sponsor: Instituto Valenciano de Infertilidad, IVI VALENCIA
Sponsor class: OTHER
First posted: 2008-03-12
Enrollment: 570
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Oocyte donation is a well established procedure in assisted reproduction treatments (ART). It is demonstrated that the use of hormonal substitution therapy, for the synchronization of the cycles between the recipients and the donors, provides good results, similar to the ones obtained with the natural cycle. In the patients - recipients with preserved ovarian function, the recipient's natural cycle is annulled, thus preventing the spontaneous Luteinizing Hormone surge. Simultaneously and while waiting for the suitable donor, her endometrium is prepared. When the donation occurs and fertilization with the husband sperm takes place, her cycle is stimulated again in order to synchronize her window of implantation with the donor's ovulation.

Two different medications are commonly used to inhibit spontaneous ovulation: either GnRHa agonist or GnRH antagonists. The present study consists of the comparison between the single dose GnRH agonist (Decapeptyl 3,75 IM) and the 7 day dosage of GnRH antagonist (Cetrotide 0,25 mg). The administration of GnRHa is used fundamentally as a long liberation formulation, administered in a single intramuscular injection (IM), which is more practical in terms of use. Nevertheless, the unnecessary persistence and the potentially unfavorable action of GnRHa during the luteal phase and early gestation have questioned its use. The recovery of the Hypophysarian function begins only 8 weeks after the single injection of long liberation of triptorelina 3.75 mg. The GnRH antagonist (Cetrotide 0,25 mg) makes the hypofisary inhibition shorter than with the analogues and can prepare similar endometrium characteristics as a natural cycle. The recipients will be assigned randomly to a group of treatment or another.


Eligibility criteria: Inclusion Criteria:

* infertile females with preserved gonadal function
* ages 18 - 43 years old

Exclusion Criteria:

* BMI: \> 28
* recurrent miscarriages
* severe male factor
* important miomas
* \> 44 years old

Primary outcomes:
measure: clinical pregnancy rate
timeFrame: 1 month
Secondary outcomes:
measure: implantation rate
timeFrame: 1 month
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: IVI Valencia
Study officials:
References:
Clinical trial NCT07016347: GDF15 in Anorexia Nervosa
Official title: Elevated Plasma GDF15 Combined With FGF21 Suggests Mitochondrial Dysfunction in a Subgroup of Anorexia Nervosa Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anorexia Nervosa
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2025-06-11
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: swedish population

Brief summary: Evaluating plasma levels of a protein called GDF15 in active and recovered anorexia nervosa, as well as healthy controls


Eligibility criteria: Inclusion Criteria:

- active DSMV diagnosis of anorexia nervosa/ at least two years of recovery from DSMV anorexia nervosa / no history of anorexia nervosa

Exclusion Criteria:

- male

Primary outcomes:
measure: plasma GDF15
timeFrame: At baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet
Study officials:
References:
Clinical trial NCT06450847: Effect of Soleus Muscle Push Ups on Oxidative Stress and Inflammatory Markers, Soleus Endurance, and Adipocytokines Between Type 2 Diabetic, Overweight/Obese and Normal Weight Individuals.
Official title: Effect of Soleus Muscle Push Ups on Oxidative Stress and Inflammatory Markers, Soleus Endurance, and Adipocytokines Between Type 2 Diabetic, Overweight/Obese and Normal Weight Individuals.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Diabete Type 2
Obesity
Overweight
Lead sponsor: University of Sharjah
Sponsor class: OTHER
First posted: 2024-06-10
Enrollment: 72
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aims to investigate the impact of Soleus Push Ups (SPU) on Soleus Muscle endurance, Oxidative Stress Markers, Inflammatory markers and Adipocytokines among people in the United Arab Emirates. This will be a pre-post intervention study with participants divided into three groups: Lean normal metabolic profile, metabolically healthy overweight/obese, and patients with Type 2 Diabetes Mellitus. Assessment of anthropometry and body composition, Soleus Muscle Endurance, blood tests for Inflammatory Markers, Oxidative Stress Markers, and Adipocytokines will be conducted pre and post-intervention.


Eligibility criteria: Inclusion Criteria:

* Residents of UAE, both males and females
* Ages 20-50 years
* Uncomplicated Type 2 Diabetic on meds,
* Normal lean BMI
* Overweight and Obese

Exclusion Criteria:

* Recent orthopedic surgery in the LLs
* Pain in the LLs starting from Hips to Ankle.
* Presence of Varicose Veins in the LLs
* Present History of any cardiovascular condition
* Pregnant females
* Morbid Obesity
* Diabetics undergoing Insulin therapy only
* Smokers and alcohol consumption

Primary outcomes:
measure: Adipocytokine levels in the blood
timeFrame: 3 months
Secondary outcomes:
measure: Soleus Muscle endurance through Heel Raise Test. • Inflammatory and Oxidative Stress markers through blood sample.
timeFrame: 3 months
Other outcomes:
measure: BMI
timeFrame: 3 months
measure: Anthropometric data including weight, height and fat percentage
timeFrame: 3 months
measure: Physical Activity and Food habits
timeFrame: 3 months
measure: Venous blood specimens
timeFrame: 3 months
Locations:
Study officials:
References:
Clinical trial NCT00776347: Donepezil Therapy and Changes of Symptoms and Glucose Metabolism in Patients With Dementia With Lewy Bodies (DLB)
Official title: Donepezil Therapy and Changes of Symptoms and Glucose Metabolism in Patients With Dementia With Lewy Bodies (DLB)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia With Lewy Bodies (DLB)
Keywords: Dementia with Lewy bodies (DLB)
FDG-PET
Lead sponsor: Osaka University
Sponsor class: OTHER
First posted: 2008-10-21
Enrollment: 24
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to evaluate change of cerebral glucose metabolism by donepezil therapy and to associate change of glucose metabolism and symptoms.


Eligibility criteria: Inclusion Criteria:

DLB patients:

* who fulfill the diagnostic criteria of DLB
* 60 to 85 years old
* right-handed
* Clinical Dementia Rating (CDR) ≧ 0.5
* Mini Mental State Examination (MMSE) score from 10 to 26

Normal Controls:

* who are independent
* who have no subjective or objective cognitive impairment
* 60 to 85 years old
* right-handed
* MMSE score over 24

Exclusion Criteria:

DLB patients:

* who have diabetes mellitus
* who have pathological change on MRI other than brain atrophy
* who have complication or history of dementia other than DLB, psychiatric disease, and physical disorder that affect brain function
* who have severe complication of cardiovascular, hepatic, renal, or other diseases unable to secure the safety
* who have severe digestive ulcus
* who have severe bronchitic asthma or obstructive lung disease
* who have no caregiver who knows patient's condition well

Normal Controls:

* who have diabetes mellitus
* who have taken donepezil before
* who have abnormal findings on MRI
* who have complication or history of brain injury, psychiatric disease, and physical disorder that affect brain function

Primary outcomes:
measure: FDG-PET
timeFrame: 14 weeks
Secondary outcomes:
measure: Cognitive function, psychiatric symptoms, global clinical function, and burden of caregiver
timeFrame: 14 weeks
Other outcomes:
Locations:
city: Suita,
country: Japan
facility: Osaka University Hospital
state: Osaka
Study officials:
affiliation: Osaka University
name: Hiroaki Kazui, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kanemoto H, Kazui H, Adachi H, Yoshiyama K, Wada T, Nomura KT, Shimosegawa E, Ikeda M. Thalamic pulvinar metabolism, sleep disturbances, and hallucinations in dementia with Lewy bodies: Positron emission tomography and actigraphy study. Int J Geriatr Psychiatry. 2020 Aug;35(8):934-943. doi: 10.1002/gps.5315. Epub 2020 Jun 8.
Clinical trial NCT01659047: A Phase 2, Single-Arm, Open-Label Study Evaluating the Efficacy and Safety of Single Agent GS 1101 (CAL 101) as Therapy for Previously Treated Chronic Lymphocytic Leukemia
Official title: A Phase 2, Single-Arm, Open-Label Study Evaluating the Efficacy and Safety of Single Agent GS 1101 (CAL 101) as Therapy for Previously Treated Chronic Lymphocytic Leukemia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Chronic Lymphocytic Leukemia
Keywords: Chronic Lymphocytic Leukemia
CLL
CAL-101
Ofatumumab
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2012-08-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effect of GS-1101 on the onset, magnitude, and duration of tumor control

Detailed description: This is a Phase 2, multicenter, single-arm, controlled, clinical trial evaluating the efficacy and safety of the phosphatidylinositol 3-kinase delta (PI3K-delta) inhibitor GS-1101 (CAL-101) as therapy for previously treated chronic lymphocytic leukemia.

This clinical trial (Study GS-US-312-0120) is a single-arm in which compliant subjects from GS US-312-0119 -Arm B who experience progression of CLL while receiving single-agent ofatumumab therapy are potentially eligible to receive single-agent, open-label GS 1101 therapy.

Eligibility criteria: Inclusion Criteria:

* Participation in Study GS-US-312-0119
* Occurrence of confirmed progression of CLL while receiving single-agent ofatumumab in Study GS US 312 0119.
* Permanent cessation of Study GS-US-312-0119 (single-agent ofatumumab) and no intervening or continuing therapy (including radiotherapy, chemotherapy, immunotherapy, or investigational therapy) for the treatment of CLL.
* The time from permanent cessation of single-agent ofatumumab on Study GS-US-312-0119 and the initiation of GS 1101 on Study GS-US-312-0120 is no more than 12 weeks.

Primary outcomes:
measure: Progression-free survival
timeFrame: 18 mon
measure: Patient Well-Being
timeFrame: 18 months
measure: Disease-related Biomarkers
timeFrame: 18 months
measure: Pharmacokinetics
timeFrame: 6 months
measure: Incidence of Adverse Events
timeFrame: 18 months
measure: Health Resource Utilization
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Gilead Sciences
name: Langdon Miller, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00617747: Efficacy and Tolerability of Zolmitriptan Nasal Spray
Official title: A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Parallel Group Trial to Evaluate Early Efficacy and Tolerability of Zolmitriptan (ZOMIG) Nasal Spray in the Acute Treatment of Adult Subjects With Migraine.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Migraine
Keywords: Zolmitriptan
ZOMIG
migraine
headache response
headache
headache pain
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-02-18
Enrollment: 2114
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 this study is to evaluate the effectiveness and tolerability (the ability not to experience ill effects from the study drug) of a zolmitriptan nasal spray, 5.0 mg, compared with placebo (inactive drug) for 2 migraine headaches for up to 12 weeks in adult subjects with migraine headaches


Eligibility criteria: Inclusion Criteria:

* Subject has an established diagnosis of migraine headache, with or without aura
* Subject has a medical history indicating the presence of migraine attacks for at least 1 year before the start of the trial or a minimum of 2 and maximum of 6 migraine attacks per month on average for 3 months preceding the study
* Subject has non migraine headaches on fewer than 6 days each month for 3 months preceding the study

Exclusion Criteria:

* Subject has history of basilar, ophthalmoplegic or hemiplegic migraine or serious neurologic condition associated with headache
* Subject has used a MAOI within 2 weeks of randomisation or has been given SSRI therapy or migraine prophylactic agent within 3 months of randomisation. Subject requires treatment with propranolol or cimetidine or has had an intolerable or serious adverse event while using another triptan
* Subject has a history or symptoms suggestive of ischemic heart disease, coronary artery vasospasm or other significant underlying cardiovascular disease or clinically significant abnormalities seen on an ECG or uncontrolled hypertension

Primary outcomes:
measure: Improvement in migraine headache pain from severe or moderate to mild or none
timeFrame: 15 minutes after the initial dose of trial treatment
Secondary outcomes:
measure: Headache response rate
timeFrame: 30 minutes and 1, 2 and 4 hours after dosing
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06430047: Efficacy and Safety of EsoDuo®
Official title: The Role of an EsoDuo® to Control Reflux Symptoms Related to the Acid; a Multicenter, Open-labeled, Phase 4 Study [RACER Study]
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Gastro Esophageal Reflux
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2024-05-28
Enrollment: 180
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Clinical Trial to Evaluate the Effects of EsoDuo® in Controlling Reflux Symptoms Related to the Acid

Detailed description: The Role of an EsoDuo® to Control Reflux Symptoms Related to the Acid; a Multicenter, Open-labeled, Phase 4 Study \[RACER Study\]

Eligibility criteria: Inclusion Criteria:

1. Male or Female aged ≥ 19 years
2. Patients diagnosed with non-erosive reflux disease or mild erosive reflux disease
3. Episode of heartburn the GERD symptom(either heartburn or gastric acid reflux)

Exclusion Criteria:

1. Surgery history on stomach or esophagus
2. Barrett's esophagus (over 3cm), esophageal varices, esophageal stricture, esophageal achalasia, eosinophilic esophagitis, and primary motility disorders
3. Patients diagnosed with Grade C or Grade D according to the LA Classification system during upper gastrointestinal endoscopy
4. Patients with a history of malignancy within the past 5 years prior to the screening visit (Visit 1)
5. Patients who have taken prohibited concomitant medications within 14 days prior to the screening visit or require continuous administration of prohibited medications during the trial period.
6. Clinically significant Abnormal Lab test
7. Pregnant woman, Breastfeeding woman.

Primary outcomes:
measure: The time taken to control the symptoms of GERD
timeFrame: 2 weeks after the clinical trial participation
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Cental of Korea
name: Hwoon-Yong Jung, M.D, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02171247: Comparison of Isovue 370 vs. Standard Protocol in Coronary Computed Tomographic Angiography (CTA)
Official title: Comparison of the Use of High Iodine Concentration Contrast Material (Isovue 370) vs. Standard Protocol in Coronary Computed Tomographic Angiography (CTA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Coronary Computed Tomographic Angiography
Keywords: coronary computed tomographic angiography
contrast
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2014-06-24
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Computed Tomography Angiogram (CTA) scans are performed routinely to look at the vessels in the body as an alternative to directly injecting contrast into the vessels and taking pictures. Different types of intravenous (into the vein, IV) contrast are available to fill the vessels and make them easier to see. The purpose of the study is to determine the best type of contrast for this scan.


Eligibility criteria: Inclusion Criteria:

* adult patients who are referred for coronary CTA for suspected or known coronary artery disease

Exclusion Criteria:

* creatinine greater than 2.0
* allergy to contrast media
* patients under the age of 18
* women who are pregnant or breast feeding
* patients with cardiac arrhythmia will also be excluded

Primary outcomes:
measure: Contrast to Noise Ratio
timeFrame: during scan, approximately 3 hours
measure: Image Quality
timeFrame: during scan, approximately 3 hours
measure: Motion Artifact
timeFrame: during scan, approximately 3 hours
measure: Attenuation of the Ascending Aorta and Coronary Arteries
timeFrame: during scan, approximately 3 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Duke University
name: Daniel T Boll, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00971477: Evaluation of Clinical Outcomes in an Online Teledermatology Model for the Management of Psoriasis
Official title: Evaluation of Clinical Outcomes in an Online Teledermatology Model for the Management of Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriasis
Keywords: Teledermatology
Telemedicine
Psoriasis
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2009-09-03
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to determine if an asynchronous online model of teledermatology can achieve similar clinical outcomes as compared to conventional in-office care for the management of psoriasis. The investigators also aim to determine the effects of this online care model on patient quality of life as well as patient and physician satisfaction.

The investigators' hypotheses include the following:

1. Compared to in-person visits, the online care model will result in similar clinical improvement in psoriasis disease severity.
2. Compared to in-person visits, the online care model will result in similar improvements in quality of life.
3. Providers and subjects in the online group will achieve a similar level of overall satisfaction as those in the in-person group.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older at time of consent, may be men or women.
* Requiring treatment of psoriasis for medically-indicated reasons.
* Capable of giving informed consent.
* Able to have their skin imaged by themselves or by family members.

Exclusion Criteria:

* Non-English speaking individuals.
* Individuals lacking access to a digital camera and computer with internet connection.

Primary outcomes:
measure: Psoriasis Area Severity Index (PASI)
timeFrame: Every 6-8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis Department of Dermatology
state: California
Study officials:
affiliation: UC Davis Department of Dermatology
name: April W Armstrong, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01313247: Paracetamol for Cancer Pain
Official title: Optimizing Medication for Cancer Pain. The Effect of Paracetamol. A Clinical and Pharmacological Trial to Research Whether Paracetamol Gives an Additional Effect on Pain Relief When the Patient is Treated With High Doses of Opioids
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Advanced Cancer
Opioid Use, Unspecified
Keywords: Paracetamol
opioids
cancer pain
Lead sponsor: Haraldsplass Deaconess Hospital
Sponsor class: OTHER
First posted: 2011-03-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Randomised, double-blind placebo controlled cross-over trial

Main goal:

Optimize the medical pain treatment for patients with advanced cancer disease

Study goal:

Measure paracetamol's additional analgesic effect in a situation where the patient is concomitantly treated with oral opioids eqv. morphine \> 100 mg/d.

Detailed description: National multicenter study with an intention to include 50 patients. 6 days treatment, 3d in each arm. Mean pain score last 24 h: NRS =/\> 4 All drug treatment constant during the study period. The participants are allowed to take as much rescue opioids as necessary to have adequate relief.

Paracetamol/ placebo given orally 1000 mg x 4 daily, three days in each arm, direct crossover.

Daily scoring of pain relief, ESAS, overall satisfaction and rescue medication.

Eligibility criteria: Inclusion Criteria:

* Adults (\> 18 years) of both sexes
* Diagnosed with advanced cancer disease
* Ongoing medicinal pain relief treatment in stable dosing with oral opiates equivalent to \> 100 mg oral morphine daily
* NRS median pain score last 24 hrs \> 4
* Able to take tablets (paracetamol) orally

Exclusion Criteria:

* Mental or physical deficiency precluding data collection.
* Reduced liver function judged with bilirubin, INR and transaminases
* Anticoagulation with warfarin
* Ongoing use of NSAIDs or 5-HT3 antagonists, or use of such drugs last week
* Ongoing palliative radiation treatment or radiation treatment during the last 4 weeks.

Primary outcomes:
measure: Pain reduction caused by paracetamol 4g/d
timeFrame: Last day in each 3 days study period
Secondary outcomes:
measure: Overall satisfaction with the pain treatment
timeFrame: End of each 3 days study period
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haraldsplass Deaconess Hospital
Study officials:
affiliation: Haraldsplass Deaconess Hospital
name: Jan Henrik Rosland, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: