louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00965627: Biology of Thymic Tumors
Official title: Biological Analysis of a Series of Thymoma and Thymic Carcinoma: Genetic Aberrations and Potential Therapy Targets.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thymoma
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2009-08-25
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Thymoma and thymic carcinoma patients will be retrospectively analyzed. Patients will be selected based on the availability of tumor tissue.

Brief summary: This is a retrospective analysis of biological characteristics of thymoma and thymic carcinoma patients.

Detailed description: The aim of the present study is to investigated the genetic alterations in tumor samples of a series of all WHO-defined subtypes of thymoma patients using high resolution microarray- comparative genomic hybridization (CGH) followed by hierarchical cluster analyses of the data to identify specific patterns of genetic aberrations and genes associated with each subtype. Moreover, tumor samples will be also investigated for some specific potential therapy targets by immunoistichemistry, mutation analysis, and fluorescence in situ hybridization (FISH) analysis. All these biological data will be correlated with clinical patients characteristics and survival data.

Eligibility criteria: Inclusion Criteria:

* Availability of tumor tissue and patients with thymoma and thymic carcinoma

Exclusion Criteria:

* NON Availability of tumor tissue and patients with thymoma and thymic carcinoma

Primary outcomes:
measure: Primary objective: to evaluate the presence of genetic alterations and specific potential therapy targets.
timeFrame: one year
Secondary outcomes:
measure: Secondary objective: to correlate the biological characteristics with clinical characteristics and survival data of patients.
timeFrame: one year
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: Milano
Study officials:
affiliation: Istituto Clinico Humanitas
name: Armando Santoro, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Petrini I, Wang Y, Zucali PA, Lee HS, Pham T, Voeller D, Meltzer PS, Giaccone G. Copy number aberrations of genes regulating normal thymus development in thymic epithelial tumors. Clin Cancer Res. 2013 Apr 15;19(8):1960-71. doi: 10.1158/1078-0432.CCR-12-3260. Epub 2013 Feb 26.
Clinical trial NCT05835427: The Effect of Stretching and Relaxation Exercises on Anxiety in Individuals With Fibromyalgia
Official title: The Effect of Stretching and Relaxation Exercises on Anxiety in Individuals With Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: exercise
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2023-04-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Individuals with fibromyalgia and healthy individuals will be included in the study and the effectiveness of the treatment will be examined. Within the scope of the study, relaxation and stretching exercises will be applied to both groups for eight weeks.
Primary purpose: OTHER

Brief summary: Fibromyalgia is a non-articular, chronic rheumatic disease of unknown etiology characterized by widespread musculoskeletal pain, sleep disturbance, fatigue, and the presence of multiple tender points.

Detailed description: Although the exact etiology cannot be determined in fibromyalgia, it is thought that there are many mechanisms that contribute to the formation of Fibromyalgia. Evidence for some biochemical, neurohormonal, central nervous system, immunological, psychological and environmental factors that may play a role in the disease has been found.

Eligibility criteria: Inclusion Criteria

* Volunteer
* Being diagnosed with fibromyalgia Exclusion Criteria
* Known neurological disorder
* Serious orthopedic disorders that will prevent him from exercising
* Cognitive impairment
* Using regular NSAIDs
* Being malnourished and malnourished

Primary outcomes:
measure: Fibromyalgia Impact Questionnaire
timeFrame: 8 weeks
measure: The Pittsburg Sleep Quality Index
timeFrame: 8 weeks
measure: Beck Anxiety Scale
timeFrame: 8 weeks
measure: Fibromyalgia ACR Criterion assessed by Composite the Widespread Pain Scale and the Symptom Severity Scale
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: HAZAL genç
Study officials:
References:
citation: Yoo SA, Kim CY, Kim HD, Kim SW. Effects of progressive muscle relaxation therapy with home exercise on pain, fatigue, and stress in subjects with fibromyalgia syndrome: A pilot randomized controlled trial. J Back Musculoskelet Rehabil. 2022;35(2):289-299. doi: 10.3233/BMR-191703.
Clinical trial NCT06350227: Impact of Different Hemostasis Methods on Ovarian Function and Fertility During Laparoscopic Ovarian Cystectomy of Benign Ovarian Cyst
Official title: Impact of Different Hemostasis Methods on Ovarian Function and Fertility During Laparoscopic Ovarian Cystectomy of Benign Ovarian Cyst
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ovarian Cyst Benign
Lead sponsor: West China Second University Hospital
Sponsor class: OTHER
First posted: 2024-04-05
Enrollment: 165
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: The purpose of this study is to compare the impact of different hemostasis methods during laparoscopic ovarian cystectomy on ovarian function and fertility in women with benign ovarian cysts.


Eligibility criteria: Inclusion Criteria:

1. Women diagnosed with benign ovarian cysts requiring surgical management.
2. Women who choose laparoscopic ovarian cystectomy voluntarily sign a surgical consent form.
3. Women participating in this study recognize three hemostatic methods and are ready to randomly accept one of them.
4. Women aged between 18 and 40 years old.
5. It was diagnosed by ultrasound as unilateral or bilateral benign ovarian cysts with a maximum diameter of 4-8cm. The nature of the cysts is ultimately confirmed by postoperative pathological examination.
6. Women with no previous history of ovarian surgery, chemotherapy, or pelvic radiation therapy.
7. Patients with no history of endocrine disorders such as hyperprolactinemia, hypothyroidism, or hyperthyroidism, and no history of endocrine therapy within 6 months before laparoscopic ovarian cystectomy.

Exclusion Criteria:

1. Polycystic ovary syndrome.
2. Pregnancy or lactation period.
3. Women with active pelvic inflammatory disease, genital or extragenital malignant tumors.
4. Women who have undergone two or more pelvic or abdominal surgeries.
5. Evidence of premature ovarian failure or premature menopause, such as AMH\<1ng/ml.
6. Conversion to open surgery.
7. Women who refuse to sign informed consent or are unable to attend follow-up regularly.
8. Cysts that do not originate from the ovaries or have the characteristics of malignant tumors.

Primary outcomes:
measure: Antral Follicle Count (AFC)
timeFrame: Preoperative quantity and postoperative quantity for 1, 3, and 6 months
Secondary outcomes:
measure: Anti-Mullerian hormone (AMH)
timeFrame: Preoperative level and postoperative level at 1, 3, and 6 months
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Second University Hospital, Sichuan University
state: Sichuan
Study officials:
References:
Clinical trial NCT01186627: Trial to Evaluate a Specified Type of Apgar (TEST-APGAR) Follow Up Study
Official title: Trial to Evaluate a Specified Type of Apgar (TEST-APGAR) Follow-Up Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Premature Birth
Mortality
Apgar Score
Keywords: Neurodevelopmental Impairment
Intraventricular hemorrhage
Retinopathy of prematurity
Mortality
Apgar Score
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
First posted: 2010-08-23
Enrollment: 1500
Sex: ALL
Minimum age (years): 2
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Former preterm infants with a gestational age below 32 weeks which have been included in the TEST-APGAR Study are now screened at a corrected age of 2 years after birth.

Brief summary: A specified version of the Apgar-Score, that can be used in newborns under resuscitation, was developed and its value to predict chronic damage in preterm infants will be tested.

Detailed description: Specifications of the individual items of the original Apgar score were suggested. These specifications slightly changed the Apgars' perspective, but did not alter the number of its components. The specified Apgar should therefore be easily applicable to every delivery room around the world. As a result of these specifications, the Apgar score will not express the efforts of the infant but describe its condition, independently of the requirements needed to achieve this condition. The advantage of the proposed definitions is the applicability in all infants, regardless of resuscitative efforts or gestational age.

To validate the accuracy of the specified version to predict neonatal mortality and long term neurological outcome in preterm infants the present prospective, observational study is planned. The study will test the hypothesis that the specified APGAR-score predicts mortality and morbidity better at 2 years of age than the conventional Apgar-score. Furthermore, the predictive reliability of the specified Apgar can be improved in combination with perinatal data respectively with the expanded Apgar version of the AAP/ACOG.

The primary outcome "condition at 2 years of age" is composed of death and a major neurological deficit. In this case "neurological deficit" is defined by the presence of one of the followings characteristics: index of mental development (Bayley Scale II) \<85, blindness, deafness, cerebral palsy.

Eligibility criteria: Inclusion Criteria:

* All preterm infants included in the TEST-APGAR Study

Exclusion Criteria:

* Missing parental Consent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: University Hospital Carl Gustav Carus
Study officials:
affiliation: Technische Universität Dresden
name: Mario Ruediger
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06663527: Compound Phellodendron Decoction May Promote Wound Healing After Anal Fistulotomy
Official title: Compound Phellodendron Decoction May Promote Wound Healing After Anal Fistulotomy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Fistula in Ano
Keywords: Anal fistula
Lead sponsor: The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2024-10-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Sitz-bath therapy with Chinese medicine has significant advantages in the management of postoperative wounds of anal fistula. This method not only ensures safety, efficacy, and cost-effectiveness, but also simplifies application. With a firm foundation in a historical heritage, this method is notable for their minimal adverse reactions. The fumigating-washing or sitz-bath therapy with Compound Phellodendron Decoction (CPD) for postoperative wounds of anal fistula has demonstrated efficacy in mitigating pain, reducing edema, curbing secretions, alleviating skin itching, and promoting wound healing processes. Despite the body of clinical research in this domain is substantial, the majority of studies have been limited to observing therapeutic outcomes. The intrinsic mechanisms by which these effects are achieved remain elusive. This study aims to unravel the potential mechanisms underpinning CPD's promotion of wound healing, focusing on the aspects of inflammation and immunity.


Eligibility criteria: Inclusion Criteria:age range of 18 to 80 years who had undergone anal fistulotomy procedures.

-

Exclusion Criteria:patients with Crohn's disease, pregnancy or lactation, organ dysfunction (such as heart failure, respiratory insufficiency, liver or renal impairment, gastrointestinal dysfunction), coagulopathy, autoimmune diseases, or a history of hypersensitivity to Chinese medicinal substances.

-

Primary outcomes:
measure: The healing duration of wounds
timeFrame: The healing duration of wounds, edema, exudation, and pain scores, served as the principal observation index.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00171327: Efficacy and Safety of Fluvastatin or Valsartan and Their Combination in Dyslipidemic Patients With Hypertension and Endothelial Dysfunction
Official title: Efficacy and Safety of Fluvastatin 80 mg or Valsartan 160 mg and Their Combination in Dyslipidemic Patients With Arterial Hypertension and Endothelial Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Dyslipidemia
Keywords: arterial hypertension
dyslipidemia
valsartan
fluvastatin
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 213
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients with mild to moderate hypertension, dyslipidemia (imbalanced blood lipids) and decreased vascular dilatation, receiving a cholesterol lowering diet were given either valsartan or fluvastatin for 8 weeks. At week 8 all patients were administered a combination treatment with valsartan 160 mg and fluvastatin 80 mg.


Eligibility criteria: Inclusion Criteria:

* Arterial hypertension
* Dyslipidemia
* Cholesterol lowering diet

Exclusion Criteria:

* Constant antihypertensive treatment
* Diabetes mellitus
* Myocardial infarction or stroke in the previous 3 months

Other inclusion and exclusion criteria may apply

Primary outcomes:
measure: Percent change from baseline in brachial artery flow-mediated vasodilation after 8 weeks
measure: Percent change from baseline in brachial artery flow-mediated vasodilation after 16 weeks compared to 8 weeks
Secondary outcomes:
measure: Percent change from baseline in low density lipoprotein cholesterol, total cholesterol, and triglycerides
measure: Evaluating blood pressure effect on endothelial function
measure: Evaluating total cholesterol effect on endothelial function
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Novartis
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01668927: Empirical Rescue Therapies of Helicobacter Pylori Infection
Official title: Helicobacter Pylori Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Functional Dyspepsia
Scarred Peptic Ulcer
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2012-08-20
Enrollment: 424
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The increase of antibiotic resistance to H. pylori causes failure of treatment. Furazolidone, amoxicillin and tetracycline are good candidates for rescue therapy since resistance to these three antimicrobials was rare. It is necessary to assess the efficacy and safety of these four bismuth-containing quadruple regimens with above antibiotics as empirical rescue therapies for H. pylori eradication.


Eligibility criteria: Inclusion Criteria:

* H. pylori -positive patients with functional dyspepsia and scarred peptic ulcers who had previously failed one or more eradication regimens containing clarithromycin, metronidazole and/or amoxicillin.

Exclusion Criteria:

* less than 18 years old, never receiving eradication treatment before, with previous gastric surgery, pregnancy, lactation, major systemic diseases, administration of antibiotics, bismuth, antisecretory drugs in the preceding 8 weeks

Primary outcomes:
measure: eradication rate of H. pylori
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital
state: Shanghai
Study officials:
References:
citation: Liang X, Xu X, Zheng Q, Zhang W, Sun Q, Liu W, Xiao S, Lu H. Efficacy of bismuth-containing quadruple therapies for clarithromycin-, metronidazole-, and fluoroquinolone-resistant Helicobacter pylori infections in a prospective study. Clin Gastroenterol Hepatol. 2013 Jul;11(7):802-7.e1. doi: 10.1016/j.cgh.2013.01.008. Epub 2013 Jan 29.
Clinical trial NCT05259527: Vitamin D Supplementation on Reported Rates of Taxane-Induced Neuropathy
Official title: Impact of Vitamin D Supplementation on Reported Rates of Taxane-Induced Neuropathy
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE2
Conditions: Neuropathic Pain
Keywords: Neuropathic pain
Neuropathy
Vitamin-D
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2022-02-28
Enrollment: 120
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: This is a two-arm randomized clinical trial in which 80 participants with Vitamin D deficiency and scheduled to begin taxane-based chemotherapy will be randomized to either: 1) prescribed vitamin D replacement or 2) standard of care.

Detailed description: This is a two-arm randomized clinical trial in which 80 participants with Vitamin D deficiency and scheduled to begin taxane-based chemotherapy will be randomized to either: 1) prescribed vitamin D replacement or 2) standard of care (advised to take over the counter (OTC) vitamin D).

All participants will have blood drawn for serum vitamin D analysis at Weeks 4, 8, 12, and 24 in order to document Vitamin D levels and titrate vitamin D dose (if needed in the treatment arm). Participants in both arms will complete self-report measures of neuropathic pain at baseline, Week 12, and Week 24.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of stage I-III cancer of any type, OR diagnosis of stage IV cancer being treated with curative intent
* Receiving or scheduled to begin taxane-based chemotherapy at Virginia Commonwealth University (VCU) Health Massey Comprehensive Cancer Center
* Vitamin D serum level \<20 ng/mL Note: study participants with Vitamin D serum level ≥20 ng/mL may be enrolled in the observational arm.

Exclusion Criteria:

* Pre-existing diagnosis of neuropathy
* Currently taking prescription Vitamin D (ergocalciferol)
* Inability to converse in English
* Pregnancy
* Chronic kidney disease (stage IV or greater)
* Known hyperparathyroidism
* Hypercalcemia: Calcium levels \>10.5 mg/dL Note: study participants with calcium levels \<10.5 mg/dL may be enrolled in the observational arm.

Primary outcomes:
measure: Self-reported neuropathic pain- sensory symptoms
timeFrame: 12 Weeks
measure: Self-reported neuropathic pain- motor symptoms
timeFrame: 12 weeks
measure: Self-reported neuropathic pain- autonomic symptoms
timeFrame: 12 weeks
Secondary outcomes:
measure: Self-reported neuropathic pain
timeFrame: 12 Weeks
measure: Clinical diagnosis of peripheral neuropathy
timeFrame: 12 Weeks
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Susan Hong, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05539027: Efficacy of L-Ornithine L-Aspartate (LOLA) as an Adjunct to Branched Chain Amino Acids (BCAA) Enriched Solutions on Clinical Outcomes in ICU Patients With Hepatic Encephalopathy
Official title: Efficacy of L-Ornithine L-Aspartate (LOLA) as an Adjunct to Branched Chain Amino Acids (BCAA) Enriched Solutions on Clinical Outcomes in ICU Patients With Hepatic Encephalopathy: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatic Encephalopathy
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2022-09-14
Enrollment: 140
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: One of the most significant goals of hepatic encephalopathy (HE) treatment is to reduce ammonia levels by lowering its synthesis and enhancing its detoxification which can be achieved by using non-absorbable disaccharides, antibiotics, branched-chain amino acids (BCAA), L-ornithine L-aspartate (LOLA), and probiotics.

LOLA decreases ammonia, therefore, it is presumed to decrease agitated delirium in HE patients and thus decrease their need for other sedatives. On the other hand, BCAA improve mental function in HE patients by increasing the detoxification of ammonia in muscles.

Detailed description: The most often utilized criteria for grading HE are the West Haven criteria (WHC). This grading distinguishes four levels of clinically evident hepatic encephalopathy.

West Haven criteria (WHC): \[R\]

Stage Consciousness

0. Normal

1. Mild lack of awareness
2. Lethargic
3. Somnolent but arousable
4. Coma

REFERENCES:

Ferenci P, Lockwood A, Mullen K, Tarter R, Weissenborn K, Blei AT. Hepatic encephalopathy-definition, nomenclature, diagnosis, and quantification: final report of the working party at the 11th World Congress of Gastroenterology, Vienna, 1998. Hepatology 2002; 35: 716-21.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with Liver cirrhosis based on clinical, biochemical, radiological and/or histopathology.
* Patients having overt HE, West Haven criteria (WHC) grade III-IV.

Exclusion Criteria:

* Age \< 21 years.
* Inability to obtain an informed consent from the first degree relative and/or legally authorized representative.
* Advanced cardiac or pulmonary disease.
* Presence of underlying chronic renal failure (serum creatinine \> 3 mg/dL).
* Neurodegenerative disease (including head injury and drug intoxication).
* Major psychiatric illness.
* Use of sedatives or antidepressants.
* Pregnancy or breast-feeding .
* Hepatocellular carcinoma.
* Acute on top of chronic liver failure.

Primary outcomes:
measure: Reversal of Hepatic encephalopathy or change of Hepatic encephalopathy by two grades (according to West Havens Criteria)
timeFrame: 5 days of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain-Shams University Hospitals
Study officials:
References: