louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02047851: Randomized, Blinded, Sham-controlled Trial of Acupuncture for the Management of Joint Pain in Patients With Psoriasis
Official title: Randomized, Blinded, Sham-controlled Trial of Acupuncture for the Management of Joint Pain in Patients With Psoriasis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Psoriasis
Arthralgia
Lead sponsor: University Hospital, Gentofte, Copenhagen
Sponsor class: OTHER
Collaborators: name: Aage Bangs Fond
First posted: 2014-01-28
Enrollment: 10
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: The purpose of this study is to determine whether acupuncture is helpful for patients with joint pain associated with psoriasis

Detailed description: In this study, patients with psoriasis and joint pain will receive either real acupuncture or sham acupuncture to see if acupuncture can be an effective treatment of joint pain in patients with psoriasis.

Eligibility criteria: Inclusion Criteria:

* Plaque psoriasis
* Pain from at least two peripheral joints and/or inflammatory back pain
* No or stabile treatment of the psoriasis the last 3 months
* No or stabile pain treatment the last 3 months
* Oral and written information given
* Written consent signed

Exclusion Criteria:

* Arthritis with Ultrasound verified intra articular fluid og clinical verified joint swelling
* Pregnancy og breastfeeding
* Previous treatments with acupuncture
* Treatment with anticoagulants (vitamin K-antagonists, low molecular weight heparin, unfractionated heparin, direct thrombin inhibitors, direct factor Xa inhibitors)
* Unwilling to follow protocol

Primary outcomes:
measure: Pain measured on the VAS
timeFrame: From day 0 to day 60 of the trial
measure: Improvement in life quality measured with the DLQI (Dermatology Life Quality Index)
timeFrame: From day 0 to day 60 of the study period
Secondary outcomes:
measure: Approvement in skin lesions
timeFrame: From day 0 to day 60 of the study period
Other outcomes:
Locations:
city: Hellerup
country: Denmark
facility: Gentofte University hospital
city: Hellerup
country: Denmark
facility: The departement of allergy and dermatology, Gentofte Hospital
Study officials:
References:
Clinical trial NCT00259051: A Study to Investigate the Pharmacodynamic Effect After Four-week Omeprazole Treatment of Non-erosive Reflux Disease in a Japanese Population
Official title: A Double-blind, Randomised, Parallel-group, Multicentre, Phase III Study to Investigate the Pharmacodynamic Effect by Assessment of the 24 Hours Intraesophageal pH Level, the Efficacy and Safety of Omeprazole 10mg and 20mg od in Patients With Non-erosive Reflux Disease (NERD).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non-erosive Reflux Disease
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Mitsubishi Tanabe Pharma Corporation
First posted: 2005-11-29
Enrollment: 40
Sex: ALL
Minimum age (years): 20
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 investigate the pharmacodynamic effect of omeprazole n a Japanese non-erosive reflux disease population


Eligibility criteria: Inclusion Criteria:

* Patients who identified their predominant symptom as heartburn and were classifiend as Grande M or N according to Hoshihara's modofied version of Los Angeles Classification at esophagogastroduodenoscopy. Written informed consent, ability to comply with study instructions

Exclusion Criteria:

* Patients with any ongoing gastrointestinal bleeding at the time of esopgahogastroduodenoscopy, patients with any history of erosive esophagitis or any other major diseases or concommittant drugs likely to interfere with the evaluation of this study

Primary outcomes:
measure: To investigate the pharmacodynamic effect of omeprazole 10mg and 20mg od in patients with NERD, by assessment of the change of the percentage of time with intra-esophageal pH <4 during 24 hours.
Secondary outcomes:
measure: To investigate the relation between pharmacodynamic effect and GERD symptoms,to investigate safety
Other outcomes:
Locations:
city: Ashahikawa
country: Japan
facility: Research Site
city: Fukuoka
country: Japan
facility: Research Site
city: Hiroshima
country: Japan
facility: Research Site
city: Ichihara
country: Japan
facility: Research Site
city: Kochi
country: Japan
facility: Research Site
city: Koshigaya
country: Japan
facility: Research Site
city: Kurashiki
country: Japan
facility: Research Site
city: Nakano
country: Japan
facility: Research Site
city: Nerima-ku
country: Japan
facility: Research Site
city: Oita
country: Japan
facility: Research Site
city: Osaka
country: Japan
facility: Research Site
city: Sapporo
country: Japan
facility: Research Site
city: Yamato
country: Japan
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Japan Medical Director, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03601754: Effectiveness of Closed Loop Stimulation (CLS) With His Bundle Lead Placement
Official title: Effectiveness of Closed Loop Stimulation (CLS) With His Bundle Lead Placement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sinus Node Dysfunction
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2018-07-26
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study is a prospective, non-randomized pilot study looking to evaluate the effectiveness of Closed Loop Stimulation (CLS) in sinus node dysfunction patients with HIS bundle placement. Patients with sinus node dysfunction who have previously received a Biotronik pacemaker with His bundle lead placement as part of routine care will be recruited for the study. A hand-grip exercise will be performed at the conclusion of bicycle exercise testing in order to assess the performance of CLS during isometric exercise. After the study exercise testing is completed, data will be collected from the pacemaker.


Eligibility criteria: Inclusion Criteria:

* Documented sinus node dysfunction
* Biotronik pacemaker implanted with His bundle lead placement for standard indications
* Implanted at least 30 days
* CLS has been enabled for at least 7 days or will be programmed ON for at least 7 days prior to exercise test
* Leads and device are functioning appropriately

Exclusion Criteria:

* Inability to complete treadmill/bicycle exercise test
* Planned surgical revision or replacement of the device and/or leads
* Patients who are unwilling or unable to provide informed consent

Primary outcomes:
measure: Change in heart rate from baseline to Day 30
timeFrame: Day 1, Day 30
Secondary outcomes:
measure: Greater heart response with CLS compared to predicted accelerometer based heart rate response
timeFrame: Day 1, Day 30
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Chirag Barbhaiya, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04459754: Fuzheng Yiliu-1010
Official title: Based on the Real World Prospective Cohort Study, Two-way Analysis of the Dominant Population and Corresponding Phenotypic Characteristics of Patients With Colorectal Cancer Treated by Fuzheng Yiliu Therapy Combined With Adjuvant Chemotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Colorectal Cancer Stage II and III
Lead sponsor: Guangdong Provincial Hospital of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2020-07-07
Enrollment: 189
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Real world study was used to evaluate the therapeutic effect of Fuzheng anti-tumor therapy on colorectal cancer patients in stage II and III after surgery and standard chemotherapy, and the prediction model of dominant population of Fuzheng anti-tumor therapy was constructed by using real-world data and gene expression profile data.


Eligibility criteria: Inclusion Criteria:

1. The age of the patients was 18-75 years old;
2. Radical resection of colorectal cancer (negative margin) was performed;
3. Patients with stage II high risk and stage III colorectal cancer confirmed by histology;
4. No liver, peritoneal or distant metastasis was found;
5. Patients with colorectal cancer who received standard chemotherapy or radiotherapy after operation and had no recurrence or metastasis at the end of radiotherapy and chemotherapy;
6. ECoG (Eastern Cooperative Oncology Group) score was 0-1; KPS score was 70 or above;
7. Liver function: SGOT and SGPT were less than 1.5 times of normal value, bilirubin was less than 1.5 mg / dl;
8. Renal function: creatinine \< 1.8mg/dl.

Exclusion Criteria:

1. Allergic to the drug of this scheme;
2. Pregnant or lactating women with fertility requirements during the study period;
3. Severe hypertension, coronary heart disease, diabetes and so on, which are under control for half a year due to cardiovascular accident and poor drug control, are accompanied with other uncontrollable benign diseases such as lung, kidney, liver, infection, etc;
4. Participate in other studies before and during treatment;
5. There was a history of other malignant tumors or multi-source tumors within one year;
6. Chronic hepatitis B or C (high copy viral DNA) or activity in HIV infection history or active phase;
7. Patients with tuberculosis or seizures who need to be treated (e.g. steroids or antiepileptic therapy).

Primary outcomes:
measure: Disease-free Survival
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Provincial Hospital of Chinese Medicine
state: Guangdong
Study officials:
References:
Clinical trial NCT01023854: Merits of Continuous Paravertebral Block in the Management of Renal/Adrenal Surgery by Laparotomy
Official title: Consideration of the Merits of Continuous Paravertebral Block in the Management of Renal and/or Adrenal Surgery by Laparotomy in Adults
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Indication for Renal and/or Adrenal Surgery
Keywords: Paravertebral block
loco regional anesthesia
renal surgery
PCA morphine
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2009-12-02
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The paravertebral block is an alternative in the analgesia epidural the major interest of which lives in the catheterisation of the paravertébral space allowing to assure/insure an one-sided continuous analgesia.

The main objective of the study is to bring to light the superiority of the continuous paravertébral block, as a supplement to analgesia, in the care of the renal and\\or adrenal surgery by laparotomy at the adult in terms of consumption of morphine, with regard to the classic analgesia classic.

The main assessment criterion is the consumption of morphine within first 24 postoperative hours at the patients benefiting from a paravertébral continuous block besides the classic systematic analgesia.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Patient scheduled for renal and/or adrenal surgery
* American Society of Anesthesiologists score ASA I, II, III
* Written informed consent given by the patient

Exclusion Criteria:

* Contraindication in the loco-regional anesthesia in the products of local anesthetic
* Surgery as a matter of urgency
* Pregnancy
* Congestive Cardiac insufficiency
* Severe hepatic Incapacity
* Disturbs of the coagulation
* Age \< 18 years
* ASA IV
* Patient already participating in a study or deadline 3-month-old subordinate since the end of a previous study
* Under guardianship Patient
* Psychiatric pathology or limitation of the intellectual abilities making difficult the understanding of the subjective questions.

Primary outcomes:
measure: morphine consumption during the first 24 hours
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: Cavale Blanche Hospital
Study officials:
affiliation: Brest, Hospital University
name: François LION, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00343577: Antiproteinuric Agents and Fabry Disease
Official title: Observational Study of Antiproteinuric Agents in Patients With Fabry Disease Treated With Enzyme Replacement Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fabry Disease
Proteinuria
Keywords: proteinuria
ARBs
agalsidase-beta
MDRD estimated GFR
Chronic kidney disease
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2006-06-23
Enrollment: 12
Sex: ALL
Minimum age (years): 14
Maximum age (years): 95
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: Fabry disease is a rare disorder that often has kidney involvement with increased urine protein excretion. Proteinuria is recognized as an important risk factor for progression of chronic kidney disease. Our hypothesis is that using drugs that reduce urine protein excretion (ACE inhibitors and ARBs) will have a beneficial effect on patients with Fabry disease who already are receiving enzyme replacement therapy. A longitudinal, observational study is being undertaken to determine the utility of these agents in Fabry disease, realizing that these agents are primarily indicated for reducing systemic blood pressure, and most patients with Fabry disease have relatively low blood pressures at baseline.

Detailed description: Fabry disease is a rare disorder that often has kidney involvement with increased urine protein excretion. Proteinuria is recognized as an important risk factor for progression of chronic kidney disease. Our hypothesis is that using drugs that reduce urine protein excretion (ACE inhibitors and ARBs) will have a beneficial effect on patients with Fabry disease who already are receiving enzyme replacement therapy. A longitudinal, observational study is being undertaken to determine the utility of these agents in Fabry disease, realizing that these agents are primarily indicated for reducing systemic blood pressure, and most patients with Fabry disease have relatively low blood pressures at baseline.

Eligibility criteria: Inclusion Criteria:

* genetically confirmed Fabry disease
* institution of commercially available agalsidase-beta

Exclusion Criteria:

* s/p kidney transplant

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: David G Warnock, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tahir H, Jackson LL, Warnock DG. Antiproteinuric therapy and fabry nephropathy: sustained reduction of proteinuria in patients receiving enzyme replacement therapy with agalsidase-beta. J Am Soc Nephrol. 2007 Sep;18(9):2609-17. doi: 10.1681/ASN.2006121400. Epub 2007 Jul 26.
Clinical trial NCT03924453: Usability Study of the Pearl Fertility Tracking Device
Official title: Use and Effectiveness of a Digitally Integrated Ovulation Prediction Kits for Fertility Tracking - Pearl Powered by Proov
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ovulation Disorder
Lead sponsor: MFB Fertility
Sponsor class: INDUSTRY
First posted: 2019-04-23
Enrollment: 35
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women aged 18-45 that are activity seeking to get pregnant and want to monitor their fertility status

Brief summary: This mobile application measures the level of certain hormones in the urine of a woman and is used to help pinpoint when the woman is/was most likely to get pregnant during her menstrual cycle.

Detailed description: The purpose of the study is to evaluate the accuracy of ovulation monitoring using hormone test strips in a digital way via a mobile application.

Ovulation prediction kits consist of test strips that measure three different hormones - LH (luteinizing hormone), FSH (follicle stimulating hormone), PdG (pregnanediol). Through daily testing with the mobile application, it is possible to measure these hormones and build hormonal profiles along the menstrual cycle. This way we can accurately predict and confirm ovulation, as well as calculate the most fertile days in the cycle.

There are multiple solutions that claim to accurately monitor fertility. However, some of these solutions use period statistics with high level of error, for example period trackers, or body temperature monitors. Some others use hormonal test strips in which reading/interpretation is not always easy. This study evaluates the accuracy of using hormone test strips in combination with an app that will digitally read and record data over time.

Eligibility criteria: Inclusion Criteria:

1. Female (mandatory)
2. Not currently pregnant or nursing (mandatory)
3. Aged 21-45 (advanced age can hinder hormone levels)
4. Not be diagnosed as sub fertile (infertility causes inconsistent hormone levels)
5. Not have used any form of hormonal birth control in the past 2 months (mandatory)
6. Currently trying to conceive (ideal but not required)
7. Currently reside in the US (mandatory, this study is for US residents only)

Exclusion Criteria:

1. Male
2. Pregnant
3. Nursing

Primary outcomes:
measure: Number of Participants with positive PDG test results
timeFrame: A single menstrual cycle, up to 45 days
Secondary outcomes:
Other outcomes:
Locations:
city: Boulder
country: United States
facility: MFB Fertility
state: Colorado
Study officials:
affiliation: MFB Fertility
name: Amy Beckley, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06816953: Cartilage Biomarkers and HEAD-US Score in Severe Hemophilia A Patients Receiving FVIII Prophylaxis
Official title: Cartilage Biomarkers and HEAD-US Score in Severe Hemophilia A Patients Receiving Low Dose FVIII Prophylaxis
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Hemophilia A
Keywords: Hemophilic arthropathy
Diagnostic ultrasound
Severe hemophilia A
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2025-02-10
Enrollment: 19
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: PwSHA receiving low-dose FVIII prophylaxis for ≥6 months were enrolled. Weight-based low-dose FVIII prophylaxis (10-15 IU/kg, 1-3 times/week) was continued for 4 months, then switched to PK-guided low-dose EHL FVIII prophylaxis, targeting a trough FVIII activity of 1 IU/dL, for another 4 months. ESR, CRP, ferritin, and CTX-II were measured at week 8 (during the weight-based low-dose regimen) and at week 24 (during the PK-guided regimen). HEAD-US scores were also compared at weeks 16 and 32. Bleeding rates and quality-of-life (QoL) score were analyzed parallelly.
Primary purpose: TREATMENT

Brief summary: Patients with severe hemophilia A often develop joint complication requiring careful monitoring. This study aimed to compare the effectiveness of standard low dose weight-based FVIII concentrates (CFCs) prophylaxis with pharmacokinetic-guided extended half-life FVIII concentrates (eHLFVIII) using cartilage biomarkers and HEAD-US score.


Eligibility criteria: Inclusion Criteria:

* patients with severe hemophilia A
* previously receiving standard low dose FVIII prophylaxis 1-3 times per week for at least 6 months prior to enrollment in the project
* no history of FVIII inhibitor (\<0.6 Bethesda unit/ml)
* obtained consent from both patients and their parents

Exclusion Criteria:

* patients with underlying condition affecting the joints such as osteoarthritis, metabolic bone disease, etc.

Primary outcomes:
measure: The effectiveness of standard low dose FVIII concentrate prophylaxis and PK-guided eHL FVIII prophylaxis
timeFrame: From enrollment to the end of treatment at 32 weeks
measure: The effectiveness of standard low dose FVIII concentrate prophylaxis and PK-guided eHL FVIII prophylaxis
timeFrame: From enrollment to the end of treatment at 32 weeks
Secondary outcomes:
measure: Correlation between cartilage biomarkers and Inflammatory markers
timeFrame: From enrollment to the end of treatment at 32 weeks
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Pediatric Department, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital
state: Patumwan
Study officials:
References:
Clinical trial NCT06213753: Complications of Non-Surgical Treatment in Acute Cholecystitis
Official title: Complications of Non-Surgical Treatment in Acute Cholecystitis, the Unkonwn Pathway
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Cholecystitis
Keywords: Acute Cholecystitis
Cholecystectomy
Tokyo Guidelines
Non-Surgical Treatment
Mortality
High-risk patient
Lead sponsor: Hospital del Mar
Sponsor class: OTHER
First posted: 2024-01-19
Enrollment: 1652
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients admited with the diagnostic of Acute Cholecystitis

Brief summary: Acute cholecystitis (AC) is the second most frequent pathology in Surgical Emergencies; laparoscopic cholecystectomy (LC) is the gold standard treatment, but not all patients are fit for surgery. Percutaneous Cholecystostomy (PC) is an alternative to LC but has high comorbidity. There is no protocol in our institution for Non-Surgical Treatment (NST). This study aims to analyse the complications of non-surgical treatment and a new local management algorithm

Detailed description: It's a single-centre retrospective study of 1652 adults with AC from 2011 to 2022, including baseline demographic characteristics, comorbidity severity defined as the Charlson Comorbidity Index (CCI), ASA Score, and Tokyo Guidelines' severity classification. The primary outcome is to study the complications of NST.

Eligibility criteria: Inclusion Criteria:

* Diagnostic of an Acute Cholecystitis.
* Older than 18 years old.

Exclusion Criteria:

* Younger than 18 years old.

Primary outcomes:
measure: Complications
timeFrame: 2011-2022
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: