louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01838538: Clinical Study in Treatment of Malignant Ascites of Ovarian Cancer With Intraperitoneal Injection Bevacizumab Combined With Intraperitoneal Hyperthermic Perfusion Chemotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Ovarian Cancer With Malignant Ascites
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2013-04-24
Enrollment: 54
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To study the efficacy and safety of intraperitoneal injection bevacizumab combined with intraperitoneal hyperthermic perfusion chemotherapy in treatment of malignant ascites of ovarian cancer. To analyze the clinical significance of the concentration change of vascular endothelial growth factor (VEGF) in ascites in treatment of intraperitoneal injection bevacizumab


Eligibility criteria: Inclusion Criteria:

* Signed informed consent obtained prior to initiation of any study-specific procedures and treatment as confirmation of the patient's awareness and willingness to comply with the study requirements.
* Histologically confirmed and documented ovarian cancer with malignant ascites.
* ECOG(Eastern Cooperative Oncology Group, ECOG) PS 0-2.
* Life expectancy of \>3 months.
* No serious inadequate bone marrow function, liver and renal function or significant cardiovascular disease.

Exclusion Criteria:

* Known hypersensitivity to any of the study drugs or excipients.
* Any current anti-cancer therapy.
* No evidence of ascites.
* Key organ dysfunction.
* Significant cardiovascular disease (e.g. congestive heart failure (CHF), uncontrolled cardiac arrhythmia, angina, heart valve disease, myocardial infarction and refractory hypertension need to be long time controlled by medicine).
* Non-healing wound, ulcer or bone fracture.
* Uncontrolled psychiatric history.

Primary outcomes:
measure: objective response rate
timeFrame: 24month
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: First Hospital Affiliated to the PLA General Hospital, Beijing,China
state: Beijing
Study officials:
affiliation: Chinese PLA General Hospital
name: Zhao Hui, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03609138: O-arm Assessment of Vertebral Movement Using ST2R Technique
Official title: The O-arm Assessment of Vertebral Movement Pre and Post Correction Using ST2R Technique
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Scoliosis; Adolescence
Lead sponsor: Medicrea, USA Corp.
Sponsor class: INDUSTRY
First posted: 2018-08-01
Enrollment: 0
Sex: ALL
Minimum age (years): 10
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with adolescent idiopathic scoliosis undergoing fusion surgery

Brief summary: The study is quantifying how the patients' back has been corrected using Medicrea's hardware through imaging taken before,during and after the surgery.

Detailed description: Visits include the pre-operative visit, 1 and 2 year follow-up visits. Participation includes answering questions and filling out questionnaires. There are no immediate benefits by joining this study, but could potentially help define better techniques for the future spine surgeries. The risks involved in this study are minimal and there are no alternatives to this study.

Eligibility criteria: Inclusion Criteria:

* Adolescent idiopathic scoliosis requiring selective thoracic posterior spinal instrumentation and fusion with the PASS LP system (screws, rods, hooks) and UNiD rod technology
* Age between 10 and 21
* Lenke Type 1 curve
* Consent and Assent to participate in the study

Exclusion Criteria:

* Age superior to 21 years
* Spinal deformities other than Lenke 1 type
* Use of implant other than those from the PASS LP system or sublaminar bands
* Neuromuscular or degenerative scoliosis
* Spinal cord abnormalities with any neurologic symptoms or signs
* Spinal cord lesions requiring neurosurgical interventions, such as hydromyelia requiring Arnold Chiari decompression
* Primary muscle diseases (e.g. Charcot-Marie Tooth, Guillain-Barre syndrome, Cerebral palsy, or Spina bidifa, Neurofibroma)
* Primary abnormalities of bones (e.g. osteogenesis imperfect)
* Congenital Scoliosis
* Scoliosis requiring anterior release
* Previous spinal surgery
* Absence of required preoperative data (diagnosis, consent...)

Primary outcomes:
measure: Quantify vertebral derotation with ST2R technique in AIS for Lenke Type 1 patients
timeFrame: 4 years
Secondary outcomes:
measure: Assess 3 dimensional correction pre- and post- correction using x-rays and O-arm data
timeFrame: 4 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02436538: Correlation Between Serum Anti-Müllerian Hormone & Müllerian Ducts Anomalies in Infertility
Official title: Correlation Between Serum Anti-Müllerian Hormone (AMH) Levels & Müllerian Ducts Anomalies in Patients Undergoingintracytoplasmic Sperm Injection (ICSI)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Keywords: anti-Müllerian hormone (AMH)
Mullerian anomalies
ICSI
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
Collaborators: name: The Egyptian IVF-ET Center
First posted: 2015-05-07
Enrollment: 226
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: female undergoing intraCytoplasmic sperm injection for treatment of infertility

Brief summary: Anti-Müllerian hormone (AMH), also known as Müllerian inhibiting substance, is a dimeric glycoprotein that belongs to the transforming growth factor-beta family. It is involved in the regression of the Müllerian ducts during male fetal development. In the female, AMH is solely produced by the granulosa cells of preantral and small antral follicles, and regulates ovarian activity and follicular steroidogenesis

Detailed description: Following approval of the internal review board of Egyptian IVF-ET center, a retrospective analysis will be undertaken where a detailed review of the patients files who underwent intracytoplasmic sperm injection (ICSI) trials starting January 2010 till January 2015 will be done.

Patients with diagnosed mullerian anomalies will have their name , age ,duration of infertility, serum FSH, LH ,\& AMH levels recorded. The method of diagnosis (HSG, 3D/ultrasonography, hysteroscopy, or laparoscopy) will also be documented.

Eligibility criteria: Inclusion Criteria:

* women with diagnosed mullerian anomlies whether clinically or through imaging

Exclusion Criteria:

* previous ovarian surgery
* ovarian drilling
* polycystic ovarian syndrome (PCOs).

Primary outcomes:
measure: Correlation of serum anti-Müllerian hormone (AMH) level with mullerian anomalies
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: The Egyptian IVF-ET Center
state: Maadi
Study officials:
affiliation: consultant
name: Yahia El-fassial, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Li HW, Ng EH, Wong BP, Anderson RA, Ho PC, Yeung WS. Correlation between three assay systems for anti-Mullerian hormone (AMH) determination. J Assist Reprod Genet. 2012 Dec;29(12):1443-6. doi: 10.1007/s10815-012-9880-1. Epub 2012 Nov 2.
Clinical trial NCT05417438: Survivor mHealth: Wearable Devices in Cancer Survivors
Official title: Survivor mHealth: Assessing Feasibility of a Wearable Device and App in Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Cardiovascular Diseases
Keywords: Physical activity
Wearable
Communication
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2022-06-14
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The Survivor mobile health (mHealth) study is testing the use of wearable devices (Fitbits) and a smartphone application in cancer survivors. The goal of the program is to increase survivor's physical activity levels. The Fitbit will be synced to the app and participants will receive messages and notifications about their activity levels. Participants will also complete surveys through the app asking how useful it is and ways to improve it. The study team will conduct qualitative interviews at the completion of the 3 months to see how participants liked the program, and ways it can be improved and make it more specific to cancer survivors. The study team will also conduct interviews with providers and clinic staff to assess their perceptions of patient digital health programs and preferences for receiving patient-generated health data.


Eligibility criteria: Aims 1 and 2 Inclusion Criteria:

1. Past cancer diagnosis
2. At least 18 years of age
3. Capacity to provide informed consent
4. Medically cleared to perform physical activity (as noted by Physical Activity Readiness Questionnaire form or physician's clearance if needed)
5. Owns a smartphone

Aims 1 and 2 Exclusion Criteria:

1. Is a prisoner
2. Non-English speaking
3. Is unable to provide consent
4. Under 18 years of age
5. No prior cancer diagnosis
6. Does not own a smartphone

Aim 3 Inclusion Criteria:

1. Are a current UMass Memorial Cancer Clinic patient navigator, oncologist, radiologist, or cardiologist
2. Consent to participate

Aim 3 Exclusion Criteria:

1. Not currently employed at UMass Memorial
2. Not involved in direct treatment of care coordination of cancer patients

Primary outcomes:
measure: Feasibility of Enrollment
timeFrame: Baseline
Secondary outcomes:
measure: 3-month Daily Step Count
timeFrame: At study completion, within 3-months of enrollment
measure: 1-Month Usability Overall APP Rating
timeFrame: 1-month post-enrollment
Other outcomes:
Locations:
city: Worcester
country: United States
facility: University of Massachusetts Chan Medical School
state: Massachusetts
Study officials:
affiliation: University of Massachusetts Chan Medical School
name: Jamie M Faro, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04477538: Long Term Function Outcomes and Pain in Implant-based Post-mastectomy Breast Reconstruction
Official title: The Impact of Operative Approach on Long Term Function Outcomes and Pain in Implant-based Post-mastectomy Breast Reconstruction
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Post-mastectomy Breast Reconstruction
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2020-07-20
Enrollment: 240
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants who undergone breast reconstruction surgery with plastic surgery faculty at the Washington University School of Medicine Division of Plastic and Reconstructive Surgery.

Brief summary: The objective of this proposal is to broadly assess patient physical functioning following breast reconstruction.


Eligibility criteria: Inclusion Criteria:

* Female
* At least 18 years of age
* Had a mastectomy for breast cancer or cancer prevention any time between 01/01/2010 and 06/30/2021.
* Has undergone breast reconstruction surgery with plastic surgery faculty at the Washington University School of Medicine Division of Plastic and Reconstructive Surgery.
* Able to understand and willing to sign an IRB-approved written informed consent document.

Exclusion Criteria:

-Known distant metastatic disease

Primary outcomes:
measure: Compare the physical well-being Q-score derived from the BREAST-Q between the two groups
timeFrame: Completion of study (estimated to be 30 months)
Secondary outcomes:
measure: Satisfaction with outcome
timeFrame: Completion of study (estimated to be 30 months)
measure: Satisfaction with breasts
timeFrame: Completion of study (estimated to be 30 months)
measure: Upper extremity function as measured by PROMIS Upper Extremity Short Form 7a
timeFrame: Completion of study (estimated to be 30 months)
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Terence Myckatyn, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03178838: Clinical Study of the Presence of Trichomonas Tenax and Entamoeba Gingivalis in Patients With Periodontitis
Official title: Preliminary Clinical Study of the Presence of Trichomonas Tenax and Entamoeba Gingivalis in Patients With Periodontitis Consulting to CHU of Nancy, in Periodontal Department.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Periodontitis, Adult
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2017-06-07
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients consulting in the periodontal department of CHU, Nancy.

Brief summary: The buccal cavity presents microorganismes whose the number and composition vary with oral hygiene and medical context (pathologies and associated drug therapies) of the patient. More than 1200 bacterial species have been identified, and among them, 400 are inhabitants of the sub-gingival biofilm. Among all these microorganismes, only 20 species participate to the etiopathogenesis of periodontal diseases.Some are recognised as major periodontopathogens other play unclear role in this pathology. They belong respectively to the red and orange complex of Socransky et al. (1998).

Other microorganismes such as virures, yeasts and protozoans could potentially impact the emergence and development of periodontal diseases. The presence of protozoans in periodontitis have been investigated in this study.


Eligibility criteria: Inclusion Criteria:

* Adults \> 18 years-old
* Consulting in periodontal department of CHU, Nancy
* Patient with moderate to severe periodontitis
* At least 2 periodontal sites with PPD≥ 4mm and One healthy site
* No scaling root planning in the last 6 months
* Patients insured under the French social security system

Exclusion Criteria:

* Pregnant patients
* Patients with antibiotic therapy, and/or all medecines which could modify the buccal microbiota in the last 6 months
* Tooth with endodontic periapical lesion
* Patients having a scaling root planning in the last 6 months
* Patient with guardianship

Primary outcomes:
measure: Presence of protozoans
timeFrame: baseline
Secondary outcomes:
measure: Periodontal pocket depth (mm)
timeFrame: baseline
measure: Clinical attachment loss (mm)
timeFrame: baseline
measure: Plaque and gingival index
timeFrame: baseline
measure: Mobility of the tooth (Yes/No)
timeFrame: baseline
measure: Presence of bleeding on probing (Yes/No)
timeFrame: baseline
Other outcomes:
Locations:
Study officials:
affiliation: CHRU Nancy / Université de Lorraine
name: Catherine BISSON, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00010608: Clinical Trial of Meditation for Cardiovascular Disease in Older Black Women
Official title: Clinical Trial of Meditation for Cardiovascular Disease in Older Black Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cardiovascular Diseases
Keywords: CVD
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH)
Sponsor class: NIH
Collaborators: name: Howard University
name: Morehouse College of Medicine
First posted: 2001-02-05
Enrollment: 196
Sex: FEMALE
Minimum age (years): 60
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 of meditation in preventing of atherosclerotic cardiovascular disease (CVD) in postmenopausal, older African American women.

Detailed description: Older African American women suffer from disproportionately high rates of cardiovascular (CVD) morbidity and mortality compared to white Americans. Numerous controlled studies suggest that this disparity is associated with chronic psychosocial and environmental stress. Research indicates that Transcendental Meditation (TM) may result in significant improvements in CVD risk factors in this high risk population.

Participants in this study will be randomly assigned to either active stress reduction with TM or health education control, both in addition to usual medical care, for 12 months. The primary outcome will be carotid artery atherosclerosis (IMT) measured non-invasively by quantitative B-mode ultrasonography. Secondary measures will include traditional CVD risk factors (blood pressure, serum glucose and insulin levels, obesity, and sedentary lifestyle), stress-related neurohormones (catecholamine metabolite and cortisol), psychosocial stress, and quality of life. The results of this trial will yield valuable new knowledge for the prevention of CVD through a CAM intervention in high risk older African American women.

Eligibility criteria: Inclusion Criteria:

* African American, self-identified
* Coronary artery disease (CAD/CHD) defined by laboratory examination or documented clinical history of: a)myocardial infarction; b) coronary revascularization procedure--CABG, PTCA; c) coronary angiography--at least one coronary artery with \>50% stenosis
* Informed consent
* Written Permission of participant's referring physician

Primary outcomes:
measure: Carotid artery atherosclerosis (IMT) measured non-invasively by quantitative B-mode ultrasonography
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Washington, Dc
country: United States
facility: Howard University Medical Center
state: District of Columbia
city: Atlanta
country: United States
facility: Morehouse School of Medicine
state: Georgia
city: Fairfield
country: United States
facility: Maharishi University of Management
state: Iowa
Study officials:
affiliation: Center for Health and Aging Studies
name: Robert H. Schneider, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01383408: Distinction Between Lung Cancer and Gynecological Cancers by Canine Scent Detection
Official title: Distinction Between Lung Cancer and Gynecological Cancers by Exhalation Analysis and Canine Scent Detection
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Lung Cancer
Breast Cancer
Ovarian Cancer
Keywords: breath sample analysis
exhalation analysis
volatile organic compounds
screening
lung cancer
breast cancer
ovarian cancer
canine scent detection
Lead sponsor: Schillerhoehe Hospital
Sponsor class: OTHER
Collaborators: name: Robert Bosch Gesellschaft für Medizinische Forschung mbH
First posted: 2011-06-28
Enrollment: 752
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Previous studies have shown that specially trained sniffer dogs are capable to discriminate breath samples of patients with lung cancer and healthy individuals. So far it is not known whether this differentiation is specific for lung cancer or just identifies any form of (solid) tumor. Therefore, the dog's ability to differentiate between lung cancer, breast cancer and ovarian cancer is tested.


Eligibility criteria: Inclusion Criteria:

* histologically confirmed lung or breast or ovarian cancer

Exclusion Criteria:

* other cancers
* previous medical intervention within the last 14 days before gathering of the breath sample

Primary outcomes:
measure: Specificity for Lung Cancer
timeFrame: breath samples will be tested within 40 days after gathering
Secondary outcomes:
measure: Discriminability of breast and ovarian cancer
timeFrame: breath samples will be tested within 40 days after gathering
Other outcomes:
Locations:
city: Gerlingen
country: Germany
facility: Schillerhoehe Hospital
state: Baden-Württemberg
city: Stuttgart
country: Germany
facility: Robert Bosch Hospital
state: Baden-Württemberg
Study officials:
affiliation: Schillerhoehe Hospital
name: Thorsten Walles, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Schillerhoehe Hospital
name: Godehard Friedel, MD
role: STUDY_CHAIR
affiliation: Robert Bosch Gesellschaft für Medizinische Forschung mbH
name: Wolfgang Simon, MD
role: STUDY_CHAIR
References:
citation: Boedeker E, Friedel G, Walles T. Sniffer dogs as part of a bimodal bionic research approach to develop a lung cancer screening. Interact Cardiovasc Thorac Surg. 2012 May;14(5):511-5. doi: 10.1093/icvts/ivr070. Epub 2012 Feb 17.
citation: Ehmann R, Boedeker E, Friedrich U, Sagert J, Dippon J, Friedel G, Walles T. Canine scent detection in the diagnosis of lung cancer: revisiting a puzzling phenomenon. Eur Respir J. 2012 Mar;39(3):669-76. doi: 10.1183/09031936.00051711. Epub 2011 Aug 18.