louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00611078: Environmental Pollutants and the Risk of Soft Tissue Sarcoma: A Pilot Study
Official title: Environmental Pollutants and the Risk of Soft Tissue Sarcoma: A Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Soft Tissue Sarcoma
Keywords: Soft Tissue Sarcoma
environment
pollutants
04-088
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2008-02-08
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Soft Tissue Sarcoma at Memorial Sloan Kettering Cancer Center.

Brief summary: The purpose of this study is to assess the feasibility of conducting a large hospital based case control study of the role of dioxins and dioxinlike polychlorinated dibenzofurans (PCDFs) and polychlorinated biphenyls (PCBs).


Eligibility criteria: Inclusion Criteria:

* Patients with Soft tissue sarcoma at MSKCC are eligible for this study if they meet the following criteria:
* Between 18 and 79 years of age
* were diagnosed within the previous 6 months with primary soft tissue sarcoma of one of the following histologic subtypes: liposarcoma, leiomyoscaroma, MFH, or synovial sarcoma
* are enrolled in protocol 02-060 ("Novel Biochemical and Molecularr Determinants for Soft Tissue Sarcoma"; PI, Dr. Samuel Singer)
* controls will be eligibile for this study if they meet the following criteria
* are b/w 18-79 years of age
* have no prior history of cancer (other than non melanoma skin cancer)

Exclusion Criteria:

* Individuals will be excluded if they
* are unable to sign informed consent for medical or other reasons
* do not speak english

Primary outcomes:
measure: enrollment of 60 participants
timeFrame: Conclusion of the study
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Lawrence Engel, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04373278: Infection After Free Fibula Flap Reconstruction of the Mandible: a Retrospective Cohort Study
Official title: Infection After Free Fibula Flap Reconstruction of the Mandible: a Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bone and Joint Infection
Keywords: mandibular
flap
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2020-05-04
Enrollment: 30
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients having had infection after a free flap reconstruction of the mandibule

Brief summary: Mandibular osteitis after flap reconstruction is rare but is a serious infection with significant sequelae.

The aim of this study is to describe this type of infection


Eligibility criteria: Inclusion Criteria:

* patients having had infection after a free bony flap reconstruction of the mandibule treated as an osteomyelitis at the CRIOAc between 2014 and 2020

Exclusion Criteria:

* non-bony flap

Primary outcomes:
measure: rate of failure after free fibula flap reconstruction of the mandible
timeFrame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption]
Secondary outcomes:
measure: rate of bacteria involved in failure after free fibula flap reconstruction of the mandible
timeFrame: when bacteria had growth up on culture; usually 2-3 weeks after the sample extracted on the surgery
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon
Study officials:
References:
Clinical trial NCT02945878: Predictive Factors of Acute Oral Mucositis Induced by Chemo-radiotherapy for Local Advanced Nasopharyngeal Carcinoma
Official title: Predictive Factors of Acute Oral Mucositis Induced by Intensity-Modulated Radiation Therapy With Concurrent Chemotherapy for Local Advanced Nasopharyngeal Carcinoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Nasopharyngeal Neoplasms
Stomatitis
Keywords: radiotherapy, oral mucositis,oral mucosa protection
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2016-10-26
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Histologically conformed Initial nasopharyngeal carcinoma

Brief summary: This is a prospective, observational study to analyze the clinical and dosimetric factors about the radiation oral mucositis caused by radical chemo-radiotherapy for nasopharyngeal carcinoma patients and try to find the indicators for acute radiation oral mucositis.

Detailed description: All patients received 1 - 3 concurrent chemotherapy during the intensity modulated radiotherapy. Before radiotherapy, three types of mouth mucosa are contoured in all treatment plans. Oral mucosa grades are recorded before and during treatment. Dose-volume Histograms are got to analyze the associated factors.

Eligibility criteria: Inclusion Criteria:

1. Histologically conformed Initial nasopharyngeal carcinoma
2. Patients can feed through the mouth.
3. ECOG (Eastern Cooperative Oncology Group) : 0-1.
4. No history of chemo-radiotherapy, immuno-therapy or biotherapy.
5. Normal hemodynamic indices before the recruitment (including white blood cell count\>4.0×109/L, neutrophil count\>1.5×109/L, platelet count \>100×109/L, hemoglobin≥90g/l, normal liver/kidney function).
6. Informed consent signed.

Exclusion Criteria:

1. History of malignant tumors.
2. Any severe complications contraindicated chemotherapy or radiotherapy.
3. Medical history of central nervous system, cognitive or psychological diseases;
4. Pregnant or nursing women.
5. Patients with mental disease cannot complete the questionaire.
6. Patients refused the informed consent.

Primary outcomes:
measure: gradings of oral mucositis
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
affiliation: Zhejiang Cancer Hospital
name: Yuanyuan Chen, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06537778: Perioperative Use of Atosiban for Ultrasound-indicated Cerclage to Reduce Spontaneous Preterm Birth(sPTB)
Official title: Perioperative Use of Atosiban for Ultrasound-indicated Cerclage to Reduce Spontaneous Preterm Birth(sPTB)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Cerclage
Premature Birth
Lead sponsor: Children's Hospital of Chongqing Medical University
Sponsor class: OTHER
Collaborators: name: First Affiliated Hospital of Chongqing Medical University
First posted: 2024-08-05
Enrollment: 334
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: After ultrasound-indicated cerclage, some pregnant women still experience sPTB, and there is controversy regarding the use of tocolytic agents during the perioperative period to reduce the incidence of sPTB. In this study, the investigators employed a randomized double-blind method to investigate whether the use of atosiban during the perioperative period can reduce the incidence of sPTB before 34 weeks.


Eligibility criteria: Inclusion Criteria:

* (i) Viable singleton gestation between 14 0/7 and 23 6/7 weeks of gestation.
* (ii) Previous history of miscarriage or preterm labor in mid-pregnancy.
* (iii) Transvaginal ultrasound examination showed that the cervix is 25mm or less at gestations less than 24 weeks.

Exclusion Criteria:

* (i) Women with uterine contractions.
* (ii) Vaginal bleeding.
* (iii) Symptoms of chorioamnionitis.
* (iv) Medically indicated PTB (severe preeclampsia, placental abruption, preterm premature rupture of membranes).
* (v) Major structural or chromosomal abnormalities.
* (vi) Contraindication to atosiban.
* (vii) Had received atosiban or any tocolytic agents within 7 days before their presentation.

Primary outcomes:
measure: Rate of sPTB
timeFrame: up to 34 weeks
Secondary outcomes:
measure: Rate of preterm delivery <28 or <32 weeks gestation
timeFrame: up to 32 weeks
measure: Gestational latency after cerclage placement (days)
timeFrame: through study completion, an average of 1 year
measure: Rate of preterm premature rupture of membranes
timeFrame: through study completion, an average of 1 year
measure: Gestational age at delivery (weeks)
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Women and Children's Hospital of Chongqing Medical University
state: Chognqing
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
state: Chongqing
Study officials:
References:
Clinical trial NCT05552378: Multi-Gyn FloraFem Study for Treatment of Vulvo Vaginal Candidiasis Symptoms
Official title: A Single Arm Stuidy to Confirm Safety and Efficacy of Multi-Gyn FloraFem Study for Treatment of Vulvo Vaginal Candidiasis Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vulvovaginal Candidiasis
Lead sponsor: Karo Pharma AB
Sponsor class: INDUSTRY
First posted: 2022-09-23
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Women diagnosed with Vulvovaginal Candidiasis by the health care professional will be enrolled in the study. All participants should fulfil inclusion and exclusion criteria.

The study product will be used for 5 days, once a day. The doctor will evaluate the patients before and at the end of the treatment.


Eligibility criteria: Inclusion Criteria:

* Women diagnosed with Vulvovaginal Candidiasis confirmed by:itching, and/or burning, irritation, edema, redness, crumbly white discharge
* Aged \>18 years
* Signed written informed consent form
* Willing to comply to the follow-up schedule
* Subject affiliated to a health social security system.
* Female of childbearing potential should use a contraceptive regimen recognized as effective since at least 12 weeks before screening visit, during all the study and at least 1 month after the study end.

Exclusion Criteria:

* Current clinically manifest of sexually transmitted gynecologically infection, genital tract infection, bacterial vaginosis or aerobic vaginitis (incl. clinical obvious gonorrhoea, chlamydia trachomatis or mycoplasma genitalium infection with cervicitis, urethritis, salpingitis)
* Current genital malignancies
* Chemotherapy for any reason in last 6 months
* Radiotherapy in the genitourinary system in the last 12 months
* Pregnancy or currently attempting to conceive
* Lactation
* Use of other treatment for vaginal conditions during the course of the clinical investigation
* Known allergies to ingredients of the product
* Concomitant medication for treatment of vaginal infections, or other use of intravaginal medication during the course of the clinical investigation

Primary outcomes:
measure: To determine the efficacy of Multi-Gyn FloraFem in relieving itch during vaginal candidiasis (based on 0-10 point scale score improvement > 1 related to vulvovaginal candidiasis at Visit 2.
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Gdańsk
country: Poland
facility: General Medical Centre
Study officials:
References:
Clinical trial NCT01739478: Packing of Perianal Abscess Cavities Trial: A Randomised Multicentre Trial Comparing Packing With Non-packing of the Abscess Cavity
Official title: Packing of Perianal Abscess Cavities (PPAC) Trial: A Randomised Multicentre Trial Comparing Packing With Non-packing of the Abscess Cavity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Perianal Abscess
Lead sponsor: North Western Research Collaborative
Sponsor class: NETWORK
First posted: 2012-12-03
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The aim of this study is to compare the effect of packing and non-packing on the healing rate of perianal abscess cavities. Secondary objectives are to assess quality of life, cost effectiveness and rate of abscess recurrence and fistula-in-ano formation. If there is no difference in time to healing and non-packing is shown to be safe, acceptable to the patient and cost effective, this approach may become more widely accepted.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of acute primary perianal abscess
* Have undergone surgical incision and drainage as an emergency

Exclusion Criteria:

* The abscess is the sequelae of concurrent disease or trauma
* Fourniers gangrene is suspected
* Unable to give informed consent

Primary outcomes:
measure: Time to wound healing in days, defined as complete epithelialisation of the abscess cavity.
timeFrame: 1 day to 6 weeks
Secondary outcomes:
measure: Quality of life scores as determined by the Euro QoL EQ-5D-3L
timeFrame: 10 to 14 days
Other outcomes:
measure: Abscess recurrence rate
timeFrame: 0 days to 12 months
measure: Fistula-in-ano formation rate
timeFrame: 0 days to 18 months
measure: Cost
timeFrame: 0 days to 18 months
Locations:
Study officials:
References:
Clinical trial NCT00574678: Analyzing the Composition of Tears to Identify Cancer
Official title: ACT: Analyzing the Composition of Tears to Identify Cancer (Breast, Ovarian, Colon)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Breast Cancer
Ovarian Cancer
Colon Cancer
Benign Disease
Keywords: Screening tool for cancer
Lead sponsor: University of Arkansas
Sponsor class: OTHER
Collaborators: name: Tenenbaum Family Foundation
First posted: 2007-12-17
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study will further evaluate the use of protein identification or protein pattern (signature) found in tears. We hypothesize that differences exist between the protein profile in tear fluid from patients with versus without cancer.

Detailed description: Specifically, this study will compare the protein profile in tear fluid from patients with breast, ovarian or colon cancer versus "normal male and female patients" for differences that show promise as a diagnostic indicator. If such differences can be found, then their diagnostic potential will be assessed and developed further in a subsequent study. The long-term goal of this project will be to develop a screening tool for the detection of breast and/or other cancers.

Eligibility criteria: Inclusion Criteria:

* Female or male, 18-100 years old
* Patients who present for a routine check-up
* Patients who present for the evaluation of an abnormal exam or test (mammogram, ultrasound, MRI, PET, etc.)
* May or may not have a mass present
* Patients who present for the evaluation of a palpable lump or mass
* Patients may be pre or post biopsy for a mass, as long as there is a portion of the mass remaining

Exclusion Criteria:

* Patient \< 18 y/o or \> 100 y/o
* Concurrent eye infection or trauma
* Active conjunctivitis
* Abnormal production of tears (too much or too little)

Primary outcomes:
measure: This study will further evaluate the use of tumor markers (substances in body fluids that may be elevated as a consequence of certain diseases or conditions) in the diagnosis of breast and/or other cancers.
timeFrame: Collection of specimen and analysis with SELDI-MS
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas For Medical Sciences
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: V. Suzanne Klimberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00674778: Prospective Registry on Vascular Access in Interventions in Lazio Region
Official title: Prospective Registry on Vascular Access in Interventions in Lazio Region
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Hemorrhages
Keywords: Radial
Femoral
artery
Invasive cardiology safety
Lead sponsor: San Filippo Neri General Hospital
Sponsor class: OTHER
First posted: 2008-05-08
Enrollment: 1052
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Previous randomised studies showed that radial artery catheterisation for percutaneous cardiovascular procedures has a superior safety profile than femoral access, however the confirmation of these benefits in the real world by a large, specific, observational study is still lacking.

We endeavoured to assess the access site-related outcomes of any percutaneous cardiovascular procedure by designing a prospective registry monitoring a consecutive sample of patients in a short period of time at nine Roman hospitals reflecting the contemporary state of health care.


Eligibility criteria: Inclusion Criteria:

* All patients undergoing any percutaneous cardiovascular procedure

Exclusion Criteria:

* Patients already enrolled in other clinical trials

Primary outcomes:
measure: Cumulative incidence of: (a) major and minor bleedings, (b) access site vascular complications, (c) stroke
timeFrame: in-hospital
Secondary outcomes:
measure: Cumulative incidence of (a) death, (b) myocardial infarction or reinfarction
timeFrame: in-hospital
Other outcomes:
Locations:
Study officials:
affiliation: San Filippo Neri Hospital
name: Giuseppe Richichi, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01422278: Rehabilitation of Conversion Gait Disorder
Official title: Patients With Conversion Gait Disorder - Effect on Treatment and Common Gait Patterns. Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Conversion Disorder
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian School of Sport Sciences
First posted: 2011-08-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Evaluating the effects in functional status after three weeks of cognitive - and behavioural rehabilitation on patients with gait disorder. The patients are followed up as after 1 and 12 months to study if any improvement is still present. The patients are being recruited from neurological units. The intervention is explanation of symptoms, positive reinforcement of normal behaviour and absence reinforcement of dysfunctional behaviour. In addition the study aims at describing typical gait patterns at patients with gait disorder by using biomechanical measurements (EKG).

Detailed description: Patients are being recruited from neurological unit/ div and out patients department of SSR and are randomized to treatment or control group. Essential gait disorders do to conversion symptoms and willingness to participate in either of the two groups with informed consent are required.

Eligibility criteria: Inclusion Criteria:

* To determine the changes in functional status after three weeks of multidisciplinary rehabilitation in patients with conversion walking disorder.

Exclusion Criteria:

* Essential gait disorders do to conversion symptoms and willingness to participate in either of the two groups with informed consent are required.

Primary outcomes:
measure: Change in gait patterns
timeFrame: three weeks
Secondary outcomes:
measure: Improved life quality
timeFrame: 12 months
Other outcomes:
Locations:
city: Stavern
country: Norway
facility: Vestfold Hospital Trust, clinic physical medicine and rehabilitation
state: Vestfold
Study officials:
affiliation: National committees for research ethics in Norway" for REK
name: Georg Høyer, DH
role: STUDY_CHAIR
References:
Clinical trial NCT04574778: Randomized Trial of Intraoperative IV Versus Preoperative Oral Acetaminophen During Ambulatory Lumbar Discectomy
Official title: Randomized Trial of IV Versus Oral Acetaminophen for Ambulatory Lumbar Discectomy or Single-level Decompression
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Pain, Postoperative
Spine Surgery
Lead sponsor: Rothman Institute Orthopaedics
Sponsor class: OTHER
First posted: 2020-10-05
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Effective non-opioid analgesics are of particular interest in ambulatory surgery, as providers may be able to reduce pain while avoiding perioperative opioids that can delay same day discharge. The value of maintaining an efficient flow of patients from the perioperative area to discharge is an important metric for same day surgery centers, and an improvement in efficiency with IV acetaminophen could potentially offset the increased cost of the medication while providing a more pleasant surgical experience for patients. The goal of this study is to compare the efficacy of intraoperative IV administration vs. preoperative oral administration of acetaminophen on postoperative opioid utilization, patient-reported pain scores, opioid-related adverse effects, and time to recovery and discharge from the post-anesthesia care unit (PACU) after ambulatory lumbar discectomy.


Eligibility criteria: Inclusion Criteria:

* Age greater than 18 years-old
* Weight greater than 50 kg body weight
* ASA physical status I-III
* English-speaking

Exclusion Criteria:

* Weight less than 50 kg
* Pregnancy or breast feeding
* revision surgery
* Contraindications to the administration of acetaminophen (e.g. allergy, liver failure, etc)
* Chronic pain conditions unrelated to back pain
* Opioid tolerance ( defined as taking greater than oxycodone 20 mg daily for a week during the past month).

Primary outcomes:
measure: Postoperative opioid usage
timeFrame: 1 day
Secondary outcomes:
measure: Quality of recovery
timeFrame: 1 day
measure: Number of patients who report nausea or vomiting
timeFrame: 1 day
measure: Mean pain score
timeFrame: 1 day
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Rothman Orthopaedic Institute
state: Pennsylvania
Study officials:
References: