louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01377428: Efficacy of Indacaterol 150 µg Versus Formoterol
Official title: A 12-week Treatment, Multicenter, Randomized, Double Blind, Double Dummy, Parallel-group Study to Assess the Efficacy of Indacaterol (150 μg o.d.) in Patients With Chronic Obstructive Pulmonary Disease, Using Formoterol (12 μg b.i.d.) as an Active Control
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: COPD
Indacaterol
Formoterol
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-06-21
Enrollment: 0
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will be a 12 week treatment (84 days), parallel group, randomized, double blind, double dummy, study to assess the superiority of indacaterol (150 μg o.d.) versus formoterol (12 μg b.i.d.) in terms of trough forced expiratory volume in 1 second (FEV1).

Patients will be enrolled after giving informed consent and then begin a screening/run-in period for 14 days. Patients will be randomized to one of two treatment groups using an allocation ratio of 1:1 to receive either indacaterol (150 μg o.d.) and placebo to formoterol, or formoterol (12 μg b.i.d.) and placebo to indacaterol for a treatment period of 12 weeks.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2009) and:

  * Post-bronchodilator FEV1 \<80% and ≥40% of the predicted normal value
  * Post-bronchodilator FEV1/FVC (forced vital capacity) \<70%
* Smoking history of at least 10 pack-years

Exclusion Criteria:

* Patients who have had a COPD exacerbation in the 6 weeks prior to screening
* Patients who have had a respiratory tract infection within 6 weeks prior to screening
* Patients with concomitant pulmonary disease
* Patients with a history of asthma
* Patients with diabetes Type I or uncontrolled diabetes Type II
* Any patient with lung cancer or a history of lung cancer
* Patients with a history of certain cardiovascular comorbid conditions

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: 24-h post-dose trough forced expiratory volume in 1 second (FEV1)
timeFrame: After 84 days of treatment
Secondary outcomes:
measure: 24-h post-dose trough inspiratory capacity (IC)
timeFrame: After 84 days of treatment
Other outcomes:
Locations:
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT04958928: Termination of Persistent Atrial Fibrillation by Catheter Ablation
Official title: A Prospective, Multicenter, Cohort Study of Termination of Persistent Atrial Fibrillation by Catheter Ablation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Fibrillation
Lead sponsor: Shanghai Chest Hospital
Sponsor class: OTHER
Collaborators: name: Wuhan Central Hospital
name: Ruijin Hospital
name: Beijing Chao Yang Hospital
name: The Third Xiangya Hospital of Central South University
name: The First Affiliated Hospital of Dalian Medical University
name: Xiamen Cardiovascular Hospital, Xiamen University
name: The Third People's Hospital of Chengdu
First posted: 2021-07-12
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with persistent AF.

Brief summary: This is a prospective, multicenter, cohort study aims to demonstrate the role of termination of AF in ablation for persistent atrial fibrillation, and evaluate the clinical outcomes in patients with or without AF termination.


Eligibility criteria: Inclusion Criteria:

1. Aged 18 to 80 years old; 2. Persistent AF; 3. Nonresponse or intolerance to ≥1 antiarrhythmic drug.

Exclusion Criteria:

1. With uncontrolled congestive heart failure;
2. Having significant valvular disease and/or prosthetic heart valve(s);
3. With myocardial infarction or stroke within 6 months of screening;
4. With Significant congenital heart disease;
5. Ejection fraction was \<40% measured by echocardiography;
6. Allergic to contrast media;
7. Contraindication to anticoagulation medications;
8. Severe pulmonary disease e.g. restrictive pulmonary disease, chronic obstructive disease (COPD);
9. Left atrial (LA) thrombus measured by pre-procedure transesophageal echocardiography;
10. Having any contraindication to right or left sided heart catheterization; 11. Previous atrial fibrillation ablation;

12. Presence of an implanted cardioverter-defibrillator; 13. Any cardiac surgery within the past 2 months; 14. Poor general health; 15.Life expectancy less than 6 months.

Primary outcomes:
measure: AF recurrence rate
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05254028: The Effectiveness of Auricular Point Compared to Body Point Acupuncture Theraphy on Tension-Type Headache
Official title: The Effectiveness of Auricular Point Compared to Body Point Acupuncture Theraphy on Healthcare Workers With Tension-Type Headache in RSUPN Dr. Cipto Mangunkusumo Jakarta
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tension-Type Headache
Keywords: Acupuncture
Auricular acupuncture
Tension-type headache
Healthcare worker
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2022-02-24
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the effectiveness of manual acupuncture between 2 types of points in decreasing tension-type headache symptoms of healthcare workers in Dr.Cipto Mangunkusumo hospital

Detailed description: The purpose of this study is to compare the effectiveness of manual acupuncture therapy between auricular points and body points in improving tension-type headache symptoms based on a headache diary which is consisting of intensity and frequency of headache days, a short form-36 questionnaire, and an examination of the press pressure threshold on eight pericranial muscles. If the use of auricular points is proven to be superior, then this method will benefit the patient more because it is more efficient and can be used as a protocol for providing therapy to patients with tension-type headache.

Eligibility criteria: Inclusion Criteria:

* Healthcare workers who work in Dr. Cipto Mangunkusumo hospital
* Age 18-60 years
* Has an episodic or chronic TTH classification and is in accordance with the diagnostic criteria in the International Classification of Headache Disorders 3rd edition beta version (ICHD-3beta)
* Headache with VAS score of 10-70 mm
* Willing to participate in research and sign an informed consent
* Willing to follow the research process to completion.

Exclusion Criteria:

* Migraine headaches or secondary headaches
* Long-term (\>10 days per month) uninterrupted use of NSAIDs and other analgesia drugs 24 hours before starting acupuncture therapy
* Has contraindications to acupuncture, namely: medical emergencies, pregnancy, history of bleeding disorders (including the use of anticoagulant drugs) obtained from anamnesis history, tumor, or infection at the acupuncture site.
* Ear deformities and earlobe infections
* Fever 38°C
* Have had acupuncture therapy in the last 7 days.

Primary outcomes:
measure: Headache intensity
timeFrame: 6 weeks
measure: Frequency of headache day
timeFrame: 6 weeks
measure: Pain Pressure Threshold (PPT)
timeFrame: 2 weeks
measure: Short form-36 questionnaire (SF-36)
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Dr. Cipto Mangunkusumo hospital
state: DKI Jakarta
Study officials:
affiliation: Fakultas Kedokteran Universitas Indonesia
name: Fieka Meitaqwatiningarum, dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02388828: CART-meso Long-term Follow-up
Official title: Long-term Follow-up of Subjects Exposed to Lentiviral-based CART-meso Gene Therapy Products in Cancer Studies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Subjects Who Have Received Lentiviral-based CART-meso Therapy
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2015-03-17
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects who have received lentiviral-based CARTmeso therapy

Brief summary: This is a non-therapeutic, long-term follow-up (LTFU) study of subjects who have received retroviral-based gene therapy products in cancer studies. All subjects in this LTFU protocol have received lentiviral modified T cells engineered to express an anti-mesothelin scFv Chimeric Antigen Receptor (CAR). This gene therapy product is called CART-meso. Lentiviruses are a subfamily of retroviruses. This protocol is designed in adherence with the November 2006 Food and Drug Administration (FDA) Guidance for Industry, "Monitoring for Delayed Adverse Events" and "Supplemental Guidance on Testing for Replication Competent Retrovirus in Retroviral Vector Based Gene Therapy Products and During Follow-up of Patients in Clinical Trials Using Retroviral Vectors " and involves up to 15 years of monitoring of subjects who have been exposed to retrovirus-mediated gene transfer. Subjects will undergo biannual visits for a blood test evaluating persistence of cells with retroviral vector sequences, chemistry, hematology and tumor markers (as applicable). On annual visits, subjects will further undergo a physical exam and medical history (including concomitant medications and adverse events) with careful attention to features possibly related to retrovirus-induced diseases


Eligibility criteria: Inclusion Criteria:

* Subjects will be enrolled into this destination protocol because they have received CART-meso cells that were genetically modified with a lentiviral vector. All subjects who have participated in a lentiviral vector study under IND #15882 and have received CART-meso cells will be asked to participate in this protocol.
* Subjects 18 years of age and older
* Subjects who have provided informed consent prior to their study participation.

Exclusion Criteria:

* None

Primary outcomes:
measure: Number of Adverse Events
timeFrame: At each visit until study completion, up to 15 years
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Andrew Haas, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00220428: T-Cell Vaccination in Multiple Sclerosis (MS)
Official title: The Effect of T-Cell Vaccination in Multiple Sclerosis - Phase I/II Safety and Efficacy Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Multiple Sclerosis
Keywords: T cell
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2005-09-22
Enrollment: 20
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: ECT

Brief summary: The purpose of this study is to evaluate the safety of T-cell vaccination in MS patients.

Detailed description: Immunization of MS patients with irradiated autologous encephalitogenic myelin peptides (EMP) specific T-cell lines or clones.

Clinical immunologic and neuroradiologic evaluation.

Eligibility criteria: Inclusion Criteria:

* Definite MS (post criteria)
* Relapsing remitting or primary progressive clinical course. At least one relapse in the last two years.
* Disease duration \> 1 year
* Expanded Disability Status Scale (EDSS) between 0-6
* Brain magnetic resonance imaging (MRI) compatible with MS
* Not involved in any other clinical trials
* No other systemic disease

Exclusion Criteria:

* Does not comply with the above

Primary outcomes:
measure: safety assessment of T-cell vaccination in nonresponding MS patients
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Multiple Sclerosis Center
Study officials:
affiliation: Sackler School of Medicine
name: Anat Achiron, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02546128: LEICeSter Tendon Extracorporeal Shockwave Studies
Official title: LEICSTES = LEICeSter Tendon Extracorporeal Shockwave Studies Assessing the Benefits of the Addition of Extra-Corporeal Shockwave Treatment to a Structured Home-rehabilitation Programme for Patients With Tendinopathy.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tendinopathy
Lead sponsor: University Hospitals, Leicester
Sponsor class: OTHER
First posted: 2015-09-10
Enrollment: 720
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To assess whether the addition of Extra-corporeal Shockwave Therapy (ESWT) to a structured home-exercise programme has any additional benefit to patients with tendinopathies

Detailed description: This involves patients with one of 6 different defined chronic tendinopathies. These individual sites are run as discrete sub-studies, with randomisation n occurring within sub-study grouping

Eligibility criteria: Inclusion Criteria:

1. Patients age \>18
2. Symptoms (typically pain / stiffness) of at least 12 weeks of one of the following sites / conditions:

   1. Plantar fasciitis
   2. Insertional Achilles tendinopathy
   3. Mid-substance Achilles tendinopathy
   4. Patella tendinopathy
   5. Trochanteric pain syndrome (gluteus medius insertional tendinopathy / trochanteric bursitis)
   6. Tennis elbow
3. Referred for ESWT (shockwave) within the Sports Medicine Department
4. Objective imaging of tendon / structure confirming diagnosis and excluding tear or other structural injury (US or MRI acceptable)

Exclusion Criteria:

1. Patients with the normal exclusions for ESWT - including pre-existing skin injury over tendon site, recent steroid injection (within 6 weeks of ESWT starting), patients on anticoagulation, patients with haemophilia or other bleeding tendency, patients with current febrile illness
2. Previous ESWT treatment for the same condition

Primary outcomes:
measure: improvement in pain as assessed by a 0-10 visual analogue scale (VAS)
timeFrame: primary outcome 3 months
Secondary outcomes:
measure: improvement in pain as assessed by a 0-10 visual analogue scale (VAS)
timeFrame: secondary outcome at 6 months post treatment
measure: improvement in function as assessed by several validated patient-rated outcome measures
timeFrame: 3 months and 6 months
Other outcomes:
Locations:
city: Leicester
country: United Kingdom
facility: University Hospitals of Leicester NHS Trust
Study officials:
affiliation: UHL NHS Trust
name: Patrick Wheeler
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wheeler PC, Dudson C, Calver R, Goodall D, Gregory KM, Singh H, Boyd KT. Three Sessions of Radial Extracorporeal Shockwave Therapy Gives No Additional Benefit Over "Minimal-Dose" Radial Extracorporeal Shockwave Therapy for Patients With Chronic Greater Trochanteric Pain Syndrome: A Double-Blinded, Randomized, Controlled Trial. Clin J Sport Med. 2022 Jan 1;32(1):e7-e18. doi: 10.1097/JSM.0000000000000880.
Clinical trial NCT05581628: FREQUENCY OF FIBROMYALGIA IN PATIENTS WITH CELIAC DISEASE
Official title: EVALUATION OF THE FREQUENCY OF FIBROMYALGIA IN PATIENTS WITH CELIAC DISEASE
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Celiac Disease
Fibromyalgia
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2022-10-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Statistical analysis of the demographic data of 60 patients diagnosed with celiac according to the ESPGHAN diagnostic criteria will be performed, and the frequency of comorbid diseases will be measured. The correlation between celiac disease and fibromyalgia will be determined and possible relationships between the two diseases will be investigated. The relationship between the presence and severity of fibromyalgia and celiac disease clinical types and modified marsh classification will be examined.

Brief summary: 950 / 5.000 Çeviri sonuçları Celiac disease is an autoimmune proximal small bowel disease that develops as a persistent intolerance to gluten-like gluten in cereals, mainly wheat gluten and other cereal proteins such as barley, rye, and oats in genetically susceptible individuals. Fibromyalgia syndrome (FMS) is a chronic musculoskeletal disease characterized by chronic widespread body pain, fatigue, morning stiffness, subjective swelling, sleep disturbance, intestinal problems, multiple somatic and cognitive problems, especially in the back, neck, shoulders and hips. In terms of intestinal symptoms, very similar findings can be observed between celiac disease and fibromyalgia. For this reason, the presence of celiac disease in FMS patients has been investigated in many studies and its frequency has been found to be high. However, the frequency of FMS in patients with celiac disease is not clear, and an overlooked diagnosis of fibromyalgia may leave many symptoms untreated.


Eligibility criteria: Inclusion Criteria:

Patients who agreed to participate in the study, signed the informed consent form, had the cognitive capacity to fill in the questionnaires and scales, and were followed up with a diagnosis of celiac will be included.

Exclusion Criteria:

Patients whose celiac diagnosis is uncertain, who do not agree to participate in the study, and who do not have sufficient cognitive capacity will be excluded from the study.

Primary outcomes:
measure: Frequency of fibromyalgia
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakif university
Study officials:
References:
Clinical trial NCT04766528: Effect of Diet on the Microbiota / Endoccanabinoidome Axis in Response to Physical Activity
Official title: Effect of Dietary Composition on the Gut Microbiota / Endocannabinoidome Axis in Response to Maximal Aerobic Exercise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diet Habit
Microbial Colonization
Activity, Motor
Keywords: Microbiome
Endocannabinoids
Lead sponsor: Laval University
Sponsor class: OTHER
First posted: 2021-02-23
Enrollment: 11
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Both the endocannabinoid system and the microbiome are highly conditioned by nutrition and physical activity, and have an interdependent, bidirectional relationship. We suggest studying the interleaving between the endocannabinoidome-microbiome axis and host metabolism under the combined effect of a diet and physical activity. More specificly, we will study the link between the impact of the diet on the intestinal microbiome and the endocannabinoid reaction after intense exercise.

Detailed description: Aims of the study are to compare the impacts of two short 7-day contrasted nutritional interventions (the Mediterranean diet (MED) and the Canadian diet (CAN)) on blood metabolites (endocannabinoids) after a maximal aerobic test. A 3 weeks washout between the two diets is planned. Gut microbiome at each test will also be evaluated.

Eligibility criteria: Inclusion Criteria:

* women
* 20-30 years old
* healthy
* jogging \>1h/week and \>3h/week of physical activity
* bmi 18.5-25

Exclusion Criteria:

* postmenopausal, pregnancy or lactation
* pathology or medication
* smoking
* more than 7 alcohol consumption/week
* food allergy, food intolerance or food aversion
* important weight change in the last 6 months
* antibiotics in the last 3 months
* night worker
* pathologies

Primary outcomes:
measure: Endocannabinoid level post physical activity
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Québec
country: Canada
facility: Institut sur la nutrition et les aliments fonctionnels
Study officials:
References:
Clinical trial NCT05296928: Postoperative Pain Score of Laparoscopic Gynecological Surgeries
Official title: The Effect of the Umbilicus and Sub-umbilicus Incisions Used in Laparoscopic Gynecological Surgeries on the Postoperative Pain Score
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Incision
Gynecologic Surgery
Postoperative Pain
Keywords: laparoscopic surgery
umbilical incision
postoperative pain score
Lead sponsor: Baskent University
Sponsor class: OTHER
First posted: 2022-03-25
Enrollment: 82
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In this study, it was aimed to compare the embryonic route, the umbilicus, and the sub-umbilicus incision in terms of postoperative pain scoring. For this purpose, in laparoscopic hysterectomies performed for benign reasons, it is planned to measure the pain score at the 8th hour and 1st day postoperatively in the umbilicus and subumbilical incision. Visual analog scoring system will be used for pain scoring.

Detailed description: In this prospective randomized study, Baskent University Adana Dr. Turgut Noyan Application and Research Center for benign reasons (myomas that cause abnormal uterine bleeding, resistant to medical and hysterescopic surgery, treatment-resistant adenomyosis in which the uterus reaches 12 weeks of gestation, recurrent endometrial hyperplasia, endometriosis, stage 1 endometrial cancers that only underwent hysterectomy) in laparoscopic hysterectomies; at the entrance to the abdomen, it is planned to apply the umbilicus, which is the anatomical route, to some of the patients, and to the other part of the sub-umbilicus incision. It will be compared in terms of pain score on the 8th hour and 1st day after surgery. The minimum quorum for each group was determined by calculating 41 and taking a total of 82 patients. The simple randomization technique will be applied in the distribution to the study sets. Based on the studies, it is thought that the anatomical path may be less painful.

Eligibility criteria: Inclusion Criteria

1. Patients who underwent laparoscopic hysterectomy for benign reasons
2. Stage 1 endometrial cancers that only underwent hysterectomy

Exclusion Criteria:

1. Malign disorders
2. Uterus larger than 12 weeks of gestation

Primary outcomes:
measure: postoperative pain score
timeFrame: 8 hour
Secondary outcomes:
measure: postoperative pain score after 24 hour
timeFrame: 24 hour
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Başkent University Adana Dr. Turgut Noyan Application and Research Center
Study officials:
References: