louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01258621: Learning Curve for Laparoscopic Distal Pancreatectomy
Official title: Learning Curve for Laparoscopic Distal Pancreatectomy in a High-volume Hospital
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Lesions Located at Body or Tail.
Keywords: distal pancreatectomy, laparoscopy, learning curve
Lead sponsor: Università Vita-Salute San Raffaele
Sponsor class: OTHER
First posted: 2010-12-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Laparoscopic distal pancreatectomy (LDP) for benign and borderline pancreatic lesions has recently becoming the treatment of choice in experienced centres. No data have been published about learning curve so far. The purpose of this study was to identify the learning curve period for performing LDP.

Detailed description: Between March 2009 and August 2010 all patients with lesion of body or tail of pancreas were assessed for eligibility for LDP. Exclusion criteria were: major vessels contact in cancer patients, severe organ dysfunction, BMI \> 35, and refusing laparoscopic approach. All laparoscopic procedures were carried out by the same surgical team with large experience in open pancreatic surgery. All patients were treated according to an early recovery after surgery protocol. Primary endpoint was conversion rate. Secondary endpoints were operation time, operative blood loss, postoperative morbidity, and length of stay.

Eligibility criteria: Inclusion Criteria:

* pancreatic lesion located at body or tail

Exclusion Criteria:

* major vessels infiltration
* severe organ dysfunction
* refusing laparoscopic approach

Primary outcomes:
measure: Conversion to open surgery
timeFrame: during surgery; 3 to 5 hours from the start of the procedure
Secondary outcomes:
measure: Operative Time
timeFrame: during surgery; 3 to 5 hours from the start of the procedure
measure: Blood loss
timeFrame: during surgery; 3 to 5 hours from the start of the procedure
measure: Length of Hospital Stay
timeFrame: Postoperative. From 0 to 30 days after discharge.
Other outcomes:
Locations:
city: Milan
country: Italy
facility: San Raffaele Hospital
Study officials:
References:
Clinical trial NCT00167921: Study Comparing Premarin® Vaginal Cream Versus Premarin® Oral Tablets in Atrophic Vaginitis
Official title: A Multiple-Dose, Comparative Bioavailability Study of Premarin® Vaginal Cream Versus Premarin® Oral Tablets in Postmenopausal Women With Atrophic Vaginitis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Atrophic Vaginitis
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-14
Enrollment: 24
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this study is to characterize the systemic exposure and bioavailability at steady state of Premarin® Vaginal Cream compared with Premarin® oral tablets in postmenopausal women with atrophic vaginitis.


Eligibility criteria: Inclusion Criteria:

* Generally healthy postmenopausal women.
* Intact uterus.
* Clinical diagnosis of moderate to severe atrophic vaginitis.

Primary outcomes:
measure: To characterize the systemic exposure and bioavailability at steady state of Premarin® Vaginal Cream compared with oral Premarin® tablets in postmenopausal women with atrophic vaginitis.
Secondary outcomes:
measure: To estimate the systemic exposure in postmenopausal women taking a typical regimen.
Other outcomes:
Locations:
city: Miami
country: United States
state: Florida
city: Baltimore
country: United States
state: Maryland
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01854021: Effects of Different General Anesthesia Methods on Immune Responses in Patients Undergoing Surgery for Tongue Cancer
Official title: Effects of Different General Anesthesia Methods on Immune Responses in Patients Undergoing Surgery for Tongue Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tongue Cancer
Keywords: Anesthesia
general
Immunity
Tongue neoplasms
immune
general anesthesia
Lead sponsor: Wuhan University
Sponsor class: OTHER
First posted: 2013-05-15
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Surgical excision is the mainstay of treatment for tongue cancer. However, surgery-induced immunosuppression has been implicated in the development of post-operative septic complications and neoplasm metastasis. General anesthesia is considered to not only suppress surgical stress, but also affect the immune function directly，such as altering the number and activity of immune cells. It is reported that some anesthetics increase susceptibility to tumor metastasis, apparently by suppressing natural killer cell activity. Different anesthetic techniques and anesthetics used in anesthesia have shown different effects on immunity. Many of the studies were animal trials or performed in vitro; in addition, most are focused on a single drug. To date, there is little published prospective clinical research designed specifically to investigate the effects of different general anesthetic technique on immune function in patients with oral malignant tumors. The aim of this study is going to characterize the immune response of patients undergoing surgery for tongue cancer under 3 types of general anesthesia.


Eligibility criteria: Inclusion Criteria:

* All the patients were scheduled for elective surgery for tongue cancer under general anesthesia. None of the patients had a history of endocrine, immune and circulatory system diseases;
* Exclusion criteria were also contraindications for receiving chemotherapy

Exclusion Criteria:

* contraindications for receiving chemotherapy,
* receiving perioperative blood transfusion, or
* preoperative and perioperative treatment with hormones and immunomodulatory agent.

Patients who suffered from any surgical complications such as infection were also excluded from our study.

-

Primary outcomes:
measure: Percentages of immune cells
timeFrame: 3 days
Secondary outcomes:
measure: Percentages of T lymphocytes subsets
timeFrame: 3 days
measure: Percentages of Natural Killer cells
timeFrame: 3 days
measure: Percentages of B lymphocytes
timeFrame: 3 days
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Hospital of stomatology of wuhan university
state: Hubei
Study officials:
affiliation: Master of Department of Anesthesiology of Hospital of Stomatology, Wuhan University
name: kebin Liu
role: STUDY_DIRECTOR
References:
Clinical trial NCT03076021: Effects of Isotretinoin on CYP2D6 Activity
Official title: Effects of Isotretinoin on CYP2D6 Activity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: CYP2D6 Polymorphism
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
First posted: 2017-03-09
Enrollment: 33
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, pre-post drug interaction study evaluating an approved drug (Phase 4) with a Phase 1 study design.
Primary purpose: OTHER

Brief summary: Specific Aim: To investigate if isotretinoin (13-cis-retinoic acid) administration decreases CYP2D6 activity in adolescent patients.

Detailed description: In this aim, we will conduct a drug-drug interaction study evaluating the effects of 13-cis-retinoic acid on non-induced CYP2D6 activity in adolescent patients. Secondary analysis will evaluate the relationship between retinoid concentrations and CYP2D6 activity in these special populations

Eligibility criteria: Inclusion Criteria:

* Non-pregnant
* ≥ 12 years
* Patients with severe acne that are expected to receive isotretinoin for therapeutic reasons

Exclusion Criteria:

* Weight \< 80 lbs
* Allergy or adverse reaction to dextromethorphan, vitamin A or isotretinoin
* Pregnant or planning to become pregnant
* Unable to follow isotretinoin risk evaluation and mitigation strategies (REMS) program (also known as iPLEDGE program)
* Chronic or persistent cough accompanying asthma, smoking or chronic obstructive pulmonary disease,
* Productive cough,
* Fever,
* Known kidney disease,
* Known liver disease,
* Diabetes
* Obesity, body mass index ≥ 30 kg/m2
* Bipolar disease,
* Attention deficit disorder,
* Social phobia,
* Concurrent or use within 14 days of drugs known to interact with dextromethorphan or cytochrome P450 2D6 (CYP2D6) or drugs known to increase the risk of adverse effects from dextromethorphan
* Concurrent use of any other product containing dextromethorphan
* Consuming foods, beverages or dietary supplements known to interact with dextromethorphan or CYP2D6
* Unable to give written informed consent/assent,
* Inability to fast for 4 hours prior to study.
* Wards of the State

Primary outcomes:
measure: CYP2D6 Activity as Measured by the Molar Concentration Ratio of Dextromethorphan (DM)/Dextrophan (DX)
timeFrame: 1 week to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Mary F Hebert, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhao Y, Vary JC Jr, Yadav AS, Czuba LC, Shum S, LaFrance J, Huang W, Isoherranen N, Hebert MF. Effect of isotretinoin on CYP2D6 and CYP3A activity in patients with severe acne. Br J Clin Pharmacol. 2024 Mar;90(3):759-768. doi: 10.1111/bcp.15938. Epub 2023 Nov 21.
Clinical trial NCT03143621: The Effect of Coffee After Resection of Small Bowel
Official title: The Effect of Coffee Consumption on Return to Bowel Function After Small Bowel Resection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Ileus
Lead sponsor: Mount Carmel Health System
Sponsor class: OTHER
First posted: 2017-05-08
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, parallel-group, controlled clinical trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: Post-operative ileus ("post-op ileus") is a condition which can occur after surgery. This means that the bowels stop working correctly and food and liquids will not pass through in the normal manner. Post-op ileus can be uncomfortable and require a longer hospital stay until the bowels begin to function correctly again. Currently there are no effective methods for preventing post-op ileus. Some studies suggest there is a benefit from drinking coffee following colon or gynecological cancer surgeries with very little risk. However, the effects of coffee following small bowel surgery have not been studied. This randomized, controlled trial will compare the outcomes of patients who receive coffee during their hospital stay after small bowel surgery to similar patients who receive warm water. About 60 patients will be in each group. The main outcomes are time until the nasogastric tube is removed and length of hospital stay.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing small bowel resection. Can be elective, urgent or emergent.

Exclusion Criteria:

* Patient with atrial fibrillation who is considered a non-coffee drinker (drinks coffee less than 3 days per week over the last 4 weeks)
* Patients undergoing colon resection without removal of any portion of small bowel.

Primary outcomes:
measure: Time to removal of nasogastric tube
timeFrame: From date of hospital admission up to date of hospital discharge (anticipated up to 2 weeks)
Secondary outcomes:
measure: Time to return of bowel function
timeFrame: From date of hospital admission up to date of hospital discharge (anticipated up to 2 weeks)
measure: Length of Stay
timeFrame: From date of hospital admission up to date of hospital discharge (anticipated up to 2 weeks)
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Mount Carmel Health System
state: Ohio
Study officials:
affiliation: Mount Carmel Health System
name: Fernando Aguila, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02493621: Compare Epidural vs. Lumbar Plexus Analgesia After Hip Arthroplasty
Official title: Compare Effectiveness of Epidural vs. Lumbar Plexus Blocks in Total Hip Arthroplasty (THA) Patients Using Multimodal Pain Control
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthropathy of Hip
Keywords: Pain, Postoperative
Nerve Block
Anesthesia, Epidural
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2015-07-09
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study team will identify subject by the Primary Diagnosis of THA, (identified by CPT code 27130) and 2) either a) Epidural (CPT code 62319) or b) Lumbar plexus peripheral nerve block (CPT 62311 or 64449) with the administration of multimodal medication.

Brief summary: The goal of this retrospective chart review is to evaluate if the implementation of lumbar plexus block placement for postoperative pain have improved conditions in the postoperative period for patients undergoing total hip arthroplasty when compared to the placement of epidurals for postoperative pain management.

Detailed description: Primary outcome: 48 hour opiate consumption in patients following THA. ' Secondary outcome: Time to first ambulation, assistance needed with ambulation, opiate and regional related side effects, time to discharge orders.

Eligibility criteria: Inclusion Criteria:

* 18 years and older
* Diagnosis of:

  1. Primary THA, (identified by CPT code 27130)
  2. Either a) Epidural (CPT code 62319) or b) Lumbar plexus peripheral nerve block (CPT 62311 or 64449)
* Perioperative multimodal medication
* Hospitalized from July 1, 2012 to December 17, 2014.

Exclusion Criteria:

* THA Revision
* ICU admission postoperatively
* History of dementia

Primary outcomes:
measure: Opiate Consumption
timeFrame: 48 hours postoperative
Secondary outcomes:
measure: Time of First Ambulation
timeFrame: 48 hours
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Sylvia Wilson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06275321: Physical Exercise Benefits for Cancer Patients
Official title: Physical Exercise Benefits in Breast Cancer Patients Undergoing Treatment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer, Breast
Sports Physical Therapy
Keywords: Oncology
Quality of live
Physical exercise
Physical activity
Physical fitness
Lead sponsor: Universitat Jaume I
Sponsor class: OTHER
First posted: 2024-02-23
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: A prospective ramonized clinical trial with two groups
Primary purpose: TREATMENT

Brief summary: The purpose of the study was to analyze the effect of a synchronous-supervised online home-based group during a 6-month exercise program on physical fitness, body composition and adherence compared to an exercise recommendation group of patients undergoing breast cancer treatment without supervision.


Eligibility criteria: Inclusion Criteria:

* 18 years old or older
* Diagnosted with breast cancer
* Undergoing cancer treatment
* No medical contraindications

Exclusion Criteria:

* Medical contraindications for sport practice
* Refusal to participate in the study
* Comorbilities

Primary outcomes:
measure: Cardiorrespiratory fitness
timeFrame: 24 weeks
measure: Strength - Chair Stand (repetitions)
timeFrame: 24 weeks
measure: Flexibility
timeFrame: 24 weeks
measure: Incidence of treatments on quality of live assessed by EORTIC QLQ-C30
timeFrame: 24 weeks
measure: Adherence
timeFrame: 24 weeks
measure: Rating of perceived exertion
timeFrame: 24 weeks
measure: Strength - Hand Grip (Kilograms)
timeFrame: 24 weeks
measure: Strength - Squat Jump (height in centimeters)
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Castellón De La Plana
country: Spain
facility: Jaume I University
state: Castellón
Study officials:
affiliation: Universitat Jaume I
name: M. Elena Garcia-Roca, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitat Jaume I
name: Eladio J. Collado-Boira, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05132621: The Genital Tract Microflora in Women With Systemic Lupus Erythematosus (SLE) and Immunoglobulin A (IgA) Nephropathy.
Official title: The Genital Tract Microflora in Women With Systemic Lupus Erythematosus and IgA Nephropathy.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Systemic Lupus Erythematosus
Immunoglobulin A Nephropathy
Keywords: microbiome
systemic lupus erythematosus
IgA nephropathy
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2021-11-24
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 50 participants diagnosed with SLE and 50 participants diagnosed with IgA nephropathy will be included in the study. The control group will consist of 50 healthy participants.

Brief summary: The study hypothesis:

Systemic lupus erythematosus (SLE) is a chronic autoimmune disease with a broad spectrum of clinical manifestations. Its mechanisms are not well understood. It is known that its development is influenced by genetic factors and gender. However, it is believed that in some patients with a specific genetic predisposition, certain environmental factors such as chemicals, including drugs and toxins, smoking, or infections may initiate the development of the disease. Of particular importance seem to be infections, which by stimulating the immune system can induce new symptoms or exacerbate existing ones.

For this reason, links between the microbiome and the clinical course of SLE are being sought. Most available studies concern the intestinal microbiome. So far, the relationship between the genital tract microbiota and the clinical picture of SLE has not been documented.

Aim of the study:

This study aims to identify and differentiate the genital tract microbiota of women with a diagnosis of systemic lupus, IgA nephropathy and a control group of healthy women. The results will be correlated with the clinical presentation of these diseases. In addition, the isolated bacterial strains will be secured for further study.


Eligibility criteria: Inclusion Criteria:

* Age \>18 years,
* Confirmed diagnosis of SLE or IgA nephropathy,
* First half of the menstrual cycle, after the end of bleeding,
* Signed informed consent to participate in the study.

Exclusion Criteria:

* Lack of menstruation,
* Pregnancy,
* Active infection requiring parenteral or topical antibiotic therapy within 2 weeks before examination,
* Neoplastic disease of the reproductive tract.

Primary outcomes:
measure: Differences in microflora composition between groups of study participants
timeFrame: Two months
Secondary outcomes:
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Dept. of Immunology, Transplantology and Internal Medicine Transplantation Institute, Warsaw Medical University
Study officials:
References:
Clinical trial NCT00927121: Clinical Investigation on the Acoustic Stimulation in the Treatment of Chronic Tinnitus
Official title: l Prospective Clinical Investigation on the Acoustic Stimulation With the "Coordinated Reset of Neural Subpopulations" in the Treatment of Chronic Tinnitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Chronic Tonal Tinnitus
Lead sponsor: ANM Adaptive Neuromodulation GmbH
Sponsor class: INDUSTRY
First posted: 2009-06-24
Enrollment: 63
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: There are many treatments for chronic tinnitus that have been claimed, with varying degrees of statistical reliability. None of those treatments can eradicate the tinnitus completely. Some therapies can reduce the tinnitus symptoms (loudness, annoyance) up to 30%. Thus there is still a need of new treatments that can reduce considerably the tinnitus symptoms and improve the QOL of subjects.

Trial objectives:

* The aim of this trial is the improvement of the QOL (quality of live) by reducing the Tinnitus- Symptoms of the patient.
* To confirm the efficacy and safety of the coordinated reset technology.

These objectives will be assessed:

* By subjective and objective measurements of the Tinnitus symptoms, loudness and annoyance.


Eligibility criteria: Inclusion Criteria:

* Mentally healthy people
* Chronic tonal Tinnitus
* Older than 18 years
* Signature of the patient informed consent
* No participation in other tinnitus therapy during the clinical investigation

Exclusion Criteria:

* A necessity for hearing aid
* Auditory hallucination
* Symptomatic hearing disorders
* "Morbus Meniere",
* Tinnitus due to temporomandibular joint disorders
* Subjects who can't perceive therapeutic tones
* Brainstem diseases
* Psychiatric disorders
* Objective Tinnitus
* Insufficient treatment of general disorders, anemia, tumor, dialysis, hypertonus ect.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Jülich
country: Germany
facility: Research Center Jülich // Institute for Neurosciences and Medicine - Research Center
Study officials:
References:
citation: Tass PA, Adamchic I, Freund HJ, von Stackelberg T, Hauptmann C. Counteracting tinnitus by acoustic coordinated reset neuromodulation. Restor Neurol Neurosci. 2012;30(2):137-59. doi: 10.3233/RNN-2012-110218.
citation: Adamchic I, Langguth B, Hauptmann C, Tass PA. Psychometric evaluation of visual analog scale for the assessment of chronic tinnitus. Am J Audiol. 2012 Dec;21(2):215-25. doi: 10.1044/1059-0889(2012/12-0010). Epub 2012 Jul 30.