louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01356706: Minimally Invasive Liver Surgery for Metastases From Colorectal Cancer: Oncologic Outcome and Prognostic Factors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Long-term Oncologic Outcome of MILS in Patients With CRLM and Prognostic Indicators
Keywords: liver metastases
colorectal cancer
surgery
prognosis
Lead sponsor: University Hospital, Gasthuisberg
Sponsor class: OTHER
First posted: 2011-05-19
Enrollment: 274
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive patients sufering from colorectal liever metastases (CRLM) who undergo minimally invasive liver surgery (MILS) or open liver surgery (OLS)

Brief summary: Only few reports exist on long-term survival after minimally invasive liver surgery (MILS for colorectal liver metastases. No data are available assessing prognostic factors in the era of current modern treatment strategies. The aim of the current study is to analyze the long-term oncologic outcome after MILS for metastases from colorectal cancer and determine prognostic indicators.


Eligibility criteria: Inclusion Criteria:

* Patients with CRLM
* Surgery: resection and/or ablation
* preoperative chemotherapy and/or biological agents are allowed
* postoperative chemotherapy and/or biological agents are allowed
* simultaneous colorectal resection is allowed

Exclusion Criteria:

* primary liver cancer
* benign liver tumors
* pregnancy

Primary outcomes:
measure: overall survival
timeFrame: 5 years
Secondary outcomes:
measure: prognostic variables
timeFrame: 5 year
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven KUL
state: Vlaams-Brabant
Study officials:
References:
Clinical trial NCT02814006: Sexual Timing in Couples Actively Trying to Conceive
Official title: What is the Best Sexual Intercourse Strategy for Couples Actively Trying to Conceive?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Conception
Keywords: marital relationship
Lead sponsor: Universidade do Porto
Sponsor class: OTHER
Collaborators: name: Fundação para a Ciência e a Tecnologia
First posted: 2016-06-27
Enrollment: 244
Sex: ALL
Minimum age (years): 24
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will asses the effectiveness of two strategies for timed intercourse in couples actively trying to conceive


Eligibility criteria: Note: age limits are for female age only

Inclusion Criteria:

* Childless couples trying to conceive
* Relationship length \> one year

Exclusion Criteria:

* Couples that already had achieved a successful pregnancy
* Couples with children

Primary outcomes:
measure: Change in sexual functioning over the course of one year
timeFrame: T0 - before the intervention; T1 - one month later; T2 - six months later; T3 - one year later]
Secondary outcomes:
measure: Change in Depression over the course of one year
timeFrame: T0 - before the intervention; T1 - one month later; T2 - six months later; T3 - one year later]
measure: Change in Anxiety over the course of one year
timeFrame: T0 - before the intervention; T1 - one month later; T2 - six months later; T3 - one year later]
measure: Number of participants that attain an infertility diagnosis
timeFrame: T0 - before the intervention; T1 - one month later; T2 - six months later; T3 - one year later]
measure: Number of participants that achieve conception
timeFrame: T0 - before the intervention; T1 - one month later; T2 - six months later; T3 - one year later]
measure: Change in social support over the course of one year
timeFrame: T0 - before the intervention; T1 - one month later; T2 - six months later; T3 - one year later]
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: University of Porto, Faculty of Psychology and Educational and Education Sciences
Study officials:
affiliation: Universidade do Porto
name: Mariana V Martins, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Martins MV, Fernandes J, Pedro J, Barros A, Xavier P, Schmidt L, Costa ME. Effects of trying to conceive using an every-other-day strategy versus fertile window monitoring on stress: a 12-month randomized controlled trial. Hum Reprod. 2022 Nov 24;37(12):2845-2855. doi: 10.1093/humrep/deac228.
Clinical trial NCT03196206: Evaluate Pharmacokinetics and Safety of BMS-986177 in Participants With Normal Renal Function and With Moderate or Severe Renal Impairment
Official title: An Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics and Safety of BMS- 986177 in Participants With Normal Renal Function and Participants With Moderate and Severe Renal Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Thrombosis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2017-06-22
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Assess the pharmacokinetics, safety, and tolerability of a single dose of BMS-986177 in participants with normal renal function and moderate to severe renal impairment.


Eligibility criteria: Inclusion Criteria:

* Participants in Groups B and C will be classified by renal function by eGRF at screening and confirmed on Day -1
* Participants in Group A will be healthy participants as determined by no significant deviations in normal medical and surgical history and assessments
* Participants in Group A must have a body mass index of 18.0 to 32.0 kg/m2, inclusive
* Females must be of non-childbearing potential

Exclusion Criteria:

* Participants in Groups B and C cannot have an indwelling catheter for hemodialysis
* Participants in Groups B and C cannot have had, nor be waiting for, an organ transplant

Other protocol defined inclusion and exclusion criteria could apply

Primary outcomes:
measure: Maximum observed plasma concentration (Cmax)
timeFrame: Up to 5 days
measure: AUC from time zero to time of last quantifiable concentration (AUC (0-T))
timeFrame: Up to 5 days
measure: AUC from time zero extrapolated to infinite time (AUC (INF))
timeFrame: Up to 5 days
Secondary outcomes:
measure: Incidence of Adverse Events (AEs)
timeFrame: Up to 5 days
measure: Incidence of Serious Adverse Events ( SAEs)
timeFrame: Up to 30 days
measure: Change from baseline in electrocardiogram findings
timeFrame: Up to 5 days
measure: Change from baseline in physical examination findings
timeFrame: Up to 5 days
measure: Change from baseline in clinical laboratory test findings
timeFrame: Up to 5 days
Other outcomes:
Locations:
city: Miami
country: United States
facility: Clinical Pharmacology Of Miami Inc.
state: Florida
city: Miami
country: United States
facility: Clinical Pharmacology of Miami LLC
state: Florida
city: Orlando
country: United States
facility: Orlando Clinical Research Center
state: Florida
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Perera V, Abelian G, Li D, Wang Z, Zhang L, Lubin S, Bello A, Murthy B. Single-Dose Pharmacokinetics of Milvexian in Participants with Normal Renal Function and Participants with Moderate or Severe Renal Impairment. Clin Pharmacokinet. 2022 Oct;61(10):1405-1416. doi: 10.1007/s40262-022-01150-1. Epub 2022 Jul 30.
Clinical trial NCT04825106: Diagnostic Errors in Anaphylactic Shock
Official title: Context-dependent Diagnostic Accuracy in Anaphylactic Shock
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diagnostic Error
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 270
Sex: ALL
Minimum age (years): 24
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Diagnostic accuracy and quality of management in anaphylactic shock is assessed in three conditions: expected, unexpected with no distractor, unexpected with distractor

Detailed description: participants: physicians taking part in voluntary workshops. Participants are allocated to teams of three design: prospective, randomized, single-blind setting: simulated anaphylactic shock intervention: participants are allocated to 3 versions of the scenario: 1) expected, 2) unexpected but no distractor, 3) unexpected with distractor

Eligibility criteria: Inclusion Criteria:

* Physicians taking part in voluntary simulator workshops

Exclusion Criteria:

* Refusal to participate or to being videorecorded

Primary outcomes:
measure: Correct diagnosis of anaphylactic shock
timeFrame: 15 minutes
Secondary outcomes:
measure: Treatment of anaphylactic shock with epinephrine ≥ 0.3mg intravenously
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital
state: BS
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Stephan Marsch
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04359706: Bacterial and Fungal Microbiota of Patients With Severe Viral Pneumonia With COVID-19
Official title: Bacterial and Fungal Microbiota of Patients With Severe Viral Pneumonia With SARS-CoV2
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sars-CoV2
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2020-04-24
Enrollment: 34
Sex: ALL
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: patients suspected of SARS-CoV2 infection and admitted in ICU

Brief summary: Observational pilot single-center study aiming to determine the microbiota of critically ill patients infected with SARS-CoV-2. COVID-19 patients will be compared to historical critically ill controls with no SARS-CoV-2 infection.

Detailed description: Observational pilot single-center study aiming to determine the microbiota of critically ill patients infected with SARS-CoV-2. COVID-19 patients will be compared to historical critically ill controls with no SARS-CoV-2 infection.

Respiratory and fecal microbiota (microbial and fungal) will be determined in COVID-19 patients on bronchoalveolar lavage and rectal swab.

Inflammatory biomarkers will also be measured in COVID-19 patients.

Characteristics of study patients will be collected at ICU admission and during ICU stay.

Eligibility criteria: Inclusion Criteria:

For the Covid-19 Group: with a confirmed severe lung infection with CoV2-SARS-Cov2 admitted to the ICU.

For the Control Group:

* Historic cohort of non SARS -CoV2-infected adults admitted to the ICU (between March and October 2019),
* that was investigated for fecal microbiota in a previous study (control patients in a fecal microbiota study in patients included in the SEAT study).

Exclusion Criteria:

* For the Covid-19 group:
* Lack of coverage Patients who received antibiotic therapy within 6 weeks prior to Covid-19 symptomatology,
* Pregnant women,
* Severe immunosuppression: Neutropenia \< 0.5 G/L, Chemotherapy \< 6 months, Bone marrow transplant recipients, HIV with CD4+ lymphocytes \< 0.4 G/L
* Impossible to perform bronchoalveolar lavage,
* Non-socially insured,
* Refusal to participate in the social study

Primary outcomes:
measure: Composition of the fecal bacterial and fungal microbiota
timeFrame: At 28 days
Secondary outcomes:
measure: Analysis of the faecal microbiota from rectal swab
timeFrame: at baseline and every 7 days during 28 days
measure: Analysis of the respiratory microbiota from the bronchoalveolar lavage liquid
timeFrame: at baseline and every 7 days during 28 days
measure: Serum inflammatory markers changes
timeFrame: at 28 days,
measure: Inflammatory markers changes
timeFrame: at 28 days,
measure: Mortality
timeFrame: at 28 days,
measure: mechanical ventilation free days
timeFrame: at 28 days,
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Roger Salengro, CHU Lille
Study officials:
affiliation: University Hospital, Lille
name: Saad Nseir, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01165606: Effects of Respiratory Physiotherapy in Critically Ill Patients Ventilated for More Than 48 Hours
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mechanical Ventilation
Lead sponsor: Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
Sponsor class: OTHER
First posted: 2010-07-20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: This study aimed to determine the impact of providing chest physiotherapy on the duration of mechanical ventilation, intensive care length of stay, intensive care and hospital mortality in mechanically ventilated patients.


Eligibility criteria: Inclusion Criteria:

* Patients aged more than 18 years, admitted to the ICU needing mechanical ventilation for longer than 48 hours

Exclusion Criteria:

* Patients with ventilatory failure due to neuromuscular dysfunction

Primary outcomes:
measure: intensive care mortality
measure: 120-day mortality
Secondary outcomes:
measure: duration of mechanical ventilation
measure: intensive care length of stay
Other outcomes:
Locations:
city: Criciuma
country: Brazil
facility: Hospital São José
state: SC
Study officials:
References:
Clinical trial NCT02258906: Effect of Ulinastatin on Postoperative Renal Function in Patients Undergoing Robot-assisted Laparoscopic Partial Nephrectomy
Official title: Effect of Ulinastatin on Postoperative Renal Function in Patients Undergoing Robot-assisted Laparoscopic Partial Nephrectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Mass
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2014-10-08
Enrollment: 66
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Ulinastatin reduces systemic inflammatory responses and protects organs from ischemia/reperfusion-induced injury. The aim of this study is to evaluate the effect of ulinastatin on postoperative renal function in patients undergoing robot-assisted laparoscopic partial nephrectomy. Seventy patients, aged 20 to 79 years, scheduled for robot-assisted laparoscopic partial nephrectomy will be divided into ulinastatin (n=35) and control (n=35) groups. Randomly selected patients of the ulinastatin group are given ulinastatin. In contrast, patients in the control group receive an equivalent volume of normal saline as a placebo. The primary endpoints are postoperative renal function measured by serum creatinine, cystatin C, and urine output.


Eligibility criteria: Inclusion Criteria:

* patients who are scheduled to undergo robot-assisted laparoscopic partial nephrectomy with an American Society of Anesthesiologists (ASA) physical status I-III

Exclusion Criteria:

* Subjects are ineligible if they have severe respiratory or cardiovascular disease, renal insufficiency before operation, cognitive dysfunction, are unable to communicate or speak Korean

Primary outcomes:
measure: postoperative renal function
timeFrame: for 3 days after surgery
Secondary outcomes:
measure: systemic inflammatory response
timeFrame: for 3 days after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT03400306: A Study Evaluating the Bioavailability and Food Effect of Veliparib Tablets Followed by an Extension in Subjects With Ovarian Cancer
Official title: A Phase 1, Single-Dose, Open-Label, Randomized Cross-Over Study Evaluating the Bioavailability and Food Effect of Veliparib Tablets Followed by an Extension in Subjects With Ovarian Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Cancer - Ovarian
Keywords: Cancer - Ovarian cancer
Bioavailability
Pharmacokinetics
Bioequivalence
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2018-01-17
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will evaluate the bioavailability between the veliparib tablet formulation to the capsule formulation; and will assess the effect of food on veliparib bioavailability in participants with ovarian cancer.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.
* Laboratory values meeting protocol-specified criteria, including hematologic, kidney and liver function.
* Life expectancy of 12 weeks or greater.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
* Able to swallow and retain oral medication.
* Discontinued anti-cancer therapy and biological agent for antineoplastic intent 21 days prior to the first dose of study drug, not have undergone major surgery 28 days prior to the first dose of study drug; and have recovered to Grade 0 - 2 for any clinical significant adverse event effect(s)/toxicity(s) from previous therapy.
* Non-childbearing potential.

Exclusion Criteria:

* History or active medical condition(s) affecting absorption or motility or any surgical procedure that might interfere with gastrointestinal motility, pH or absorption.
* Evidence of refractory ascites.
* Has clinically relevant or significant electrocardiogram abnormalities.

Primary outcomes:
measure: Maximum observed plasma concentration (Cmax)
timeFrame: Up to approximately 8 days after initial dose of study drug
measure: Time to Maximum Observed Plasma Concentration (Tmax)
timeFrame: Up to approximately 8 days after initial dose of study drug
measure: Apparent Terminal Phase Elimination Rate Constant (β or Beta)
timeFrame: Up to approximately 8 days after initial dose of study drug
measure: Terminal Phase Elimination Half-life (t1/2)
timeFrame: Up to approximately 8 days after initial dose of study drug
measure: Area Under the Plasma Concentration-time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUCt)
timeFrame: Up to approximately 8 days after initial dose of study drug
measure: AUC from time 0 to infinite time (AUC∞)
timeFrame: Up to approximately 8 days after initial dose of study drug
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References:
Clinical trial NCT00435006: Hypopituitarism Following Traumatic Brain Injury or Spontaneous Subarachnoidal Haemorrhages
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Injuries
Intracranial Aneurysm
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
name: Novo Nordisk A/S
name: AP Moeller Foundation
First posted: 2007-02-14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: The purpose of this study is to assess the prevalence and predictors of pituitary dysfunction, as well as secondary out-come in patients with traumatic brain injury or spontaneous subarachnoidal haemorrhages.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of traumatic brain injury (TBI) or subarachnoidal haemorrhages (SAH)

Exclusion Criteria:

* Alcohol or drug abuse
* Prior TBI or SAH
* Chronic use of glucocorticoids
* Pregnancy or breast feeding
* Diagnosis of psychiatric diseases or malignant neoplasms

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Dept. of Endocrinology PE2131, Copenhagen University Hospital, Rigshospitalet
Study officials:
affiliation: Dept. of Endocrinology PE2131, Copenhagen University Hospital, Rigshospitalet
name: Marianne C Klose, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03789006: Antithymocyte Globulin and Azathioprine Versus Basiliximab and Mycophenolate Mofetil in Living Donor Kidney Transplantation
Official title: Efficiency of Antithymocyte Globulin and Azathioprine Versus Basiliximab and Mycophenolate Mofetil When Used in Combination With Tacrolimus and Prednisolone in Living Donor Kidney Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Kidney Transplant Rejection
Lead sponsor: University of Khartoum
Sponsor class: OTHER
Collaborators: name: National Center for Kidney Diseases and Surgery
First posted: 2018-12-28
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized clinical trial
Primary purpose: PREVENTION

Brief summary: Kidney transplantation is the best available treatment option for patients with end stage renal disease. However, kidney transplantation requires life-long use of immunosuppressive medication. Because of the high cost of these medications we need to carefully evaluate the cost-effectiveness of each drug regimen, especially in low-middle income countries. The objective of this clinical trial is to compare the efficiency and cost of two immunosuppressive protocols after living donor kidney transplantation: (1) antithymocyte globulin, tacrolimus, azathioprine and prednisolone versus (2) basiliximab, tacrolimus, mycophenolate mofetil and prednisolone.


Eligibility criteria: Inclusion Criteria:

* Adult end-stage renal disease patients
* First living donor kidney transplant.
* Moderate immunological risk.

Exclusion Criteria:

* Low immunological risk (HLA mismatches 000/100/010/110 with negative PRA).
* High immunological risk (child to mother or husband to wife transplant, 2 DR mismatches).

  * Known hypersensitivity to any of the study medication.

Primary outcomes:
measure: Incidence of acute rejection
timeFrame: 6 months post kidney transplant
measure: One year graft survival
timeFrame: 1 year post kidney transplant
Secondary outcomes:
measure: Cost of immunosuppressive medication
timeFrame: 1 year post kidney transplant+
Other outcomes:
Locations:
city: Khartoum
country: Sudan
facility: Doctor Salma Center for Kidney Diseases
Study officials:
affiliation: Consultant Nephrologist
name: Sarra Elamin, MD
role: PRINCIPAL_INVESTIGATOR
References: