louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01092052: Study of NMS-1116354 in Advanced/Metastatic Solid Tumors
Official title: A Phase I Dose-Escalation Study of NMS-1116354 in Adult Patients With Advanced/Metastatic Solid Tumors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Advanced/Metastatic Solid Tumors
Keywords: Phase I study
Advanced/Metastatic Solid Tumors
Cdc7 kinase inhibitor
Lead sponsor: Nerviano Medical Sciences
Sponsor class: INDUSTRY
First posted: 2010-03-24
Enrollment: 24
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: The purpose of this study is to evaluate the safety profile of NMS-1116354, a CDC7 kinase inhibitor, in adult patients with advanced/metastatic solid tumors.


Eligibility criteria: Inclusion Criteria:

1. Advanced/metastatic solid tumors, for which no alternative effective standard therapy is available
2. Maximum of 4 regimens of prior cancer therapy allowed
3. Prior radiotherapy allowed if no more than 25% of BM reserve irradiated
4. Resolution of all acute toxic effects (excluding alopecia) of any prior anticancer therapy
5. ECOG performance status (PS) 0 or 1
6. Adult (age \>/= 18 and \</= 80 years) patients
7. Adequate renal, liver and BM reserve
8. Capability to swallow capsules intact

Exclusion Criteria:

1. Current enrollment in another therapeutic clinical trial
2. Known brain metastases
3. Currently active second malignancy
4. Major surgery within 4 weeks prior to treatment
5. Any of the following in the past 6 months: myocardial infarction, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis
6. Pregnancy or breast-feeding women
7. Known active infections
8. Gastrointestinal disease or other malabsorption syndromes that would impact on drug absorption
9. Adrenal insufficiency
10. Other severe acute or chronic medical or psychiatric condition that could compromise protocol objectives

Primary outcomes:
measure: First cycle dose-limiting toxicities (DLTs) and related maximum tolerated dose(MTD)
timeFrame: 3 weeks
Secondary outcomes:
measure: Evaluation of pharmacokinetics: plasma concentration at different times after dosing, area under the curve (AUC), maximum plasma concentration (Cmax), time of occurence of Cmax (tmax) and half-life (t½)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Villejuif, Cedex
country: France
facility: Institut Gustave-Roussy (IGR)
Study officials:
affiliation: Institut Gustave-Roussy (IGR)
name: Jean-Charles Soria, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nerviano Medical Sciences
name: Stefania Crippa, Biotech D, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05740852: Analysis of Risk Factors of Postoperative Pulmonary Infection in Patients With Esophageal Cancer
Official title: Analysis of Risk Factors of Postoperative Pulmonary Infection in Patients With Esophageal Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Esophageal Neoplasms
Pneumonia
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2023-02-23
Enrollment: 1688
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: From January 2016 to December 2021, patients with esophageal cancer were hospitalized for surgery in the Department of Gastroenterology, Xijing Hospital.

Brief summary: The goal of this observational study is to learn about in describe participant population. The main questions it aims to answer are:

* What are the risk factors of postoperative pulmonary infection in patients with esophageal cancer？
* Whether we could establish a clinical prediction model to provide basis for early clinical intervention or not? Participants will describe the main tasks participants will be asked to do, treatments they'll be given and use bullets if it is more than 2 items. If there is a comparison group: Researchers will compare insert groups to see if insert effects.

Detailed description: Data were collected from the electronic medical records of Xijing Hospital. Each record is entered by two team members working simultaneously to ensure data accuracy.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of esophageal cancer;
* Radical resection of tumor for the first time;
* No distant metastasis was observed in preoperative examination

Exclusion Criteria:

* Patients with preoperative pulmonary infection or symptoms of pulmonary infection;
* Patients with tracheal intubation assisted ventilation before surgery;
* Patients with preoperative lung imaging changes or abnormal white blood cells in blood routine;
* Patients undergoing emergency surgery;
* Patients with other cancers;
* Patients with incomplete clinical data.

Primary outcomes:
measure: Pneumonia
timeFrame: A week after radical resection of tumor
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03555552: Point of Care Testing to Improve Monitoring of LVAD Patients
Official title: Point of Care Testing to Improve Monitoring of LVAD Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Anticoagulation and Thrombosis Point of Care Test (AT-POCT)
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2018-06-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to develop and validate the accuracy of a low-cost "point-of-care" test (POCT) that allows monitoring of markers for anticoagulation and thrombosis (local coagulation or clotting of the blood), to be used by patients with advanced heart failure (AHF) on left ventricular assist device (LVAD) support. The investigators central hypothesis is that the fully-printed AT-POCT utilizing low-cost (printed) cassettes and detector will produce an inexpensive and convenient option for daily self-monitoring of PT/INR and LDH over existing methods.


Eligibility criteria: Inclusion Criteria:

* 18 to 80 years of age
* Subject has signed Informed Consent Form (ICF)
* For LVAD patient cohort, they are on LVAD support from 2 weeks to 10 years.

Exclusion Criteria:

* Patients with dementia, altered mental status, any psychiatric condition or mental disability that would prohibit the understanding or rendering of informed consent are not eligible
* Prisoners

Primary outcomes:
measure: Interclass correlation between PT/INR and LDH measurements
timeFrame: 1 study day
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Ashutosh Chilkoti, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00397852: Dislocated Stable Distal Both-Bone Forearm Fractures in Children
Official title: Treatment of Stable Dislocated Both-Bone Distal Forearm Fractures in Children: A Randomized Trial Between Treatment With en Without Kirschner-Wires
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fracture
Forearm
Distal
Child
Treatment
Keywords: Fracture
Forearm
Distal
Child
Treatment
Lead sponsor: Colaris, Joost, M.D.
Sponsor class: INDIV
First posted: 2006-11-10
Enrollment: 110
Sex: ALL
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: We create a randomized clinical trial between treatment with and without Kirschner wire fixation of a stable dislocated distal both-bone forearm fracture.

Detailed description: children who arrive at the emergency unit with a dislocated both-bone distal forearm fracture will be asked to join the trial.

After informed consent, a randomization between 2 kinds of treatment will be done: K-wire fixation or no K-wire fixation of the fracture after a stable reposition.

Outpatient clinic visits till a follow-up of 6 months. During these visits we will investigate: the number of re-dislocations, re-operations, consolidation and dislocation on X-ray, function of both arms, complains in daily living and complications.

Eligibility criteria: Inclusion Criteria:

* both-bone forearm fracture
* distal
* dislocated
* stable after reposition
* age \< 16 years

Exclusion Criteria:

* fracture older than 1 week
* no informed consent
* refracture
* open fracture (Gustillo 2 and 3)
* both fractures of type torus

Primary outcomes:
measure: re-operations/ re-dislocations
Secondary outcomes:
measure: pronation and supination
measure: complications, function, esthetics, complains in daily living, X-rays
Other outcomes:
Locations:
city: Den Haag
country: Netherlands
facility: HAGA, location Juliana Children's Hospital
state: Zuid Holland
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Centre location Sophia Children's hospital
state: Zuid Holland
Study officials:
name: joost w colaris, drs
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05176652: Ultrasonographic Diameter of Optic Nerve Sheath in Fluid Assessment in Severe Preeclamptic Patients
Official title: Reliability of Utrasonographic Diameter of Optic Nerve Sheath in Assessment of Fluid Status in Severe Preeclamptic Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Severe Pre-eclampsia
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-01-04
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: severe preeclamptic patients (aged 18-40) after termination of pregnancy

Brief summary: Changes in the optic nerve sheath diameter detected by ultrasound are considered an important manifestation of increased intracranial pressure . The normal optic nerve sheath diameter measures up to 5.0 mm and an average optic nerve sheath diameter more than 5 mm is considered abnormal and elevated intracranial pressure should be suspected.Cerebral edema have been demonstrated in 71% to 100% of magnetic resonance imaging in preeclamptic patients and an increase in optic nerve sheath diameter has been described in preeclamptic females compared to healthy pregnant females Therefore, Increased optic nerve sheath diameter can indirectly reflect the state of intracranial edema that could be a part of generalized edema of preeclampsia and it could be a possible marker of generalized tissue edema and fluid overload in these patients.


Eligibility criteria: Inclusion Criteria:

* Systolic blood pressure of 160mm Hg or higher, or diastolic blood pressure of 110mm Hg or higher on 2 occasions at least 6 hours apart on bed rest.
* Proteinuria ≥5g in a 24 hour urine specimen or ≥3+ on 2 random urine samples collected at least 4 hours apart.
* patient acceptance
* Accepted mental state of the patients

Exclusion Criteria:

* patient refusal to participate in the study
* chronic kidney disease
* chronic pulmonary disease
* chronic cardiac disease
* chronic hypertension
* previous ocular operation and diseases

Primary outcomes:
measure: correlation between optic nerve sheath diameter and extravascular lung water
timeFrame: up to 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Hossam Eldin Hassan Ahmed Abdelghani
city: Sohag
country: Egypt
facility: Hossam Eldin Hassan Ahmed Abdelghani
city: Sohag
country: Egypt
facility: Hossam Eldin Hassan Ahmed Abdelghani
Study officials:
References:
Clinical trial NCT01717352: Sleep Plus Eating Routines for Weight Loss
Official title: Increasing Sleep Duration: A Novel Approach to Weight Control. Study 5-Randomized Trial of Sleep Plus Eating Routines as An Approach to Prepare Participants for Weight Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Overweight and Obesity
Keywords: Weight loss
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
First posted: 2012-10-30
Enrollment: 90
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The present study will test the effectiveness of two different approaches for preparing overweight/obese individuals for weight loss: 1)providing important information about weight control, including dispelling common myths; or 2) developing a consistent sleep and eating routine to prepare for the challenges of a weight control intervention.


Eligibility criteria: Inclusion Criteria:

* age 21 to 65
* BMI 25 to 45
* sleep 7 hours or less most nights

Exclusion Criteria:

* use of medications affecting sleep
* sleep apnea
* shift work

Primary outcomes:
measure: Weight
timeFrame: 20 weeks
Secondary outcomes:
measure: Executive Control
timeFrame: 4 and 20 weeks
Other outcomes:
Locations:
city: Providence
country: United States
facility: Weight Control & Diabetes Research Center
state: Rhode Island
Study officials:
affiliation: The Miriam Hospital
name: Rena R Wing, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05679752: Effects of Massage Therapy and Facial PNF in Early Bell's Palsy
Official title: Effects of Massage Therapy and Facial PNF in Early Bell's Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bell Palsy
Lead sponsor: Neuro Counsel Hospital, Pakistan
Sponsor class: OTHER
Collaborators: name: Al Nafees Medical Hospital, Islamabad
name: Reliance Hospital Rawalpindi
First posted: 2023-01-11
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized control trail
Primary purpose: OTHER

Brief summary: Effects of Massage therapy and Facial PNF in early Bell's palsy

Detailed description: It is an interventional study in which investigator will give massage therapy to one group of patients and facial PNF techniques to other group to evaluate the efficacy of these intervention on bell's palsy pateints

Eligibility criteria: Inclusion Criteria:

* Both males and females with age between 20 to 50 years
* All patients diagnosed with Bell's palsy
* Non traumatic onset
* Acute onset 1 to 3 weeks
* Either right or left side

Exclusion Criteria:

* Subject who have other Neurological disorder
* Subjects who have impaired cognition
* Complete paralysis of face
* Open wound on face

Primary outcomes:
measure: Sunnybrook facial grading scale
timeFrame: assessment will be done after 6 weeks
measure: Facial Clinimetric Evaluation Scale
timeFrame: assessment will be done after 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Al Nafees Medical Hospital, Islamabd
state: Federally Administered Tribal...
Study officials:
References:
Clinical trial NCT05617352: The Impact of Two-field or Three-field Lymphadenectomy on Overall Survival in Middle and Lower Thoracic Esophageal Squamous Cell Carcinoma: An Observational Study
Official title: The Impact of Two-field or Three-field Lymphadenectomy on Overall Survival in Middle and Lower Thoracic Esophageal Squamous Cell Carcinoma: A Single Center Retrospective Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Esophageal Cancer
Lead sponsor: Sichuan Cancer Hospital and Research Institute
Sponsor class: OTHER
First posted: 2022-11-15
Enrollment: 1659
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with esophageal cancer and need surgical treatment.

Brief summary: To clarify the effect of Two-field or Three-field Lymphadenectomy on the survival of esophageal squamous cell carcinoma.


Eligibility criteria: Inclusion Criteria:

* 1. Men and women aged 18-85 years
* 2. Histologically confirmed primary thoracic esophageal squamous cell carcinoma,
* 3. Staging PT1b-4A, N0-3, M0 AJCC eighth edition
* 4. Excluding lymph node dissection \< 15, (meeting the guideline criteria)
* 5. The tumor located in the lower middle thoracic.

Exclusion Criteria:

* 1. Patients with a history of previous thoracic and abdominal surgery that may affect lymphatic reflux
* 2. Patients with distant metastasis confirmed by imaging
* 3. Patients with obvious surgical contraindications.

Primary outcomes:
measure: The number of lymph nodes
timeFrame: 2010.1.1-2017.12.30
Secondary outcomes:
Other outcomes:
Locations:
city: Chendu
country: China
facility: Sichuan Cancer Hospital
state: Sichuan
Study officials:
References:
Clinical trial NCT02921152: Bone Marrow Micrometastases in Patients With Early Stage Breast Cancer
Official title: Bone Marrow Micrometastases in Patients With Early Stage Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Acibadem University
Sponsor class: OTHER
First posted: 2016-10-03
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Operable early stage breast cancer patients staged according to NCCN guidelines are subjected to bone marrow aspiration/trephine biopsy at the time of the definitive operation under general anesthesia. The specimen will be fixated in neutral tamponaded formalin and the sections will be examined by H\&E and cytokeratin immunohistochemically. If disseminated tumor cells are identified ER (estrogen receptor), PR (progesterone receptor), HER2/neu will be studied. Disseminated tumor cells will be recorded quantitively and semiquantitatively. Results of the pilot study will be evaluated as observational study.


Eligibility criteria: Inclusion criteria:

1. Patients over 18 years old and who have given informed consent to enter the study.
2. ASA I-II patients
3. Patients who have not been diagnosed as breast cancer or received any type of treatment regarding breast cancer before the time of study
4. Patients who are appropriate for bone marrow biopsy
5. Menopausal status is not relevant.

Exclusion criteria:

1. Active collagen tissue disorders
2. Patients who are diagnosed having breast cancer and received any type of treatment regarding breast cancer before the time of study
3. Pregnancy
4. Patients with bleeding disorders, who are receiving antiaggregant or anticoagulant medication.
5. Patients who refused to enter the study protocol and refused to give informed consent.

Primary outcomes:
measure: Rate of bone marrow metastases in early stage breast cancer
timeFrame: up to 5 years
measure: Rate of sentinel lymph node metastases in early stage breast cancer
timeFrame: up to 5 years
measure: Rate of sentinel lymph node metastases in patients with bone marrow metastasis operated for early stage breast cancer
timeFrame: up to 5 years
measure: Incidence of bone marrow metastasis in HER-2 positive early stage breast cancer
timeFrame: up to 5 years
measure: Incidence of bone marrow metastases in triple negative early stage breast cancer
timeFrame: up to 5 years
Secondary outcomes:
measure: Incidence of axillary recurrence in patients with negative sentinel lymph node biopsy
timeFrame: Up to 10 years
measure: Overall survival
timeFrame: up to 10 years
Other outcomes:
measure: Disease free survival
timeFrame: up to 10 years
Locations:
city: Istanbul
country: Turkey
facility: Acibadem University School of Medicine
Study officials:
References:
Clinical trial NCT01374152: Perfetti Method in Upper Extremity of Stroke Patients
Official title: A Randomized Controlled Trial of Cognitive Sensory Motor Training Therapy on the Recovery of Upper Extremity Function in Acute Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Stroke
Keywords: stroke
upper extremity
rehabilitation
perfetti
Lead sponsor: Prasat Neurological Institute
Sponsor class: OTHER_GOV
Collaborators: name: Mahidol University
First posted: 2011-06-15
Enrollment: 40
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: The cognitive sensory motor training therapy (Perfetti's technique) might be more effectiveness than conventional occupational therapy on upper extremity function recovery after acute stroke patients.

Detailed description: Globally, stroke is the second leading cause of death above the age of 60 years, and the fifth leading cause of death in people aged 15 to 59 years old. Upper extremities problem is still faced with poor prognosis for recovery. Cognitive sensory motor training therapy (Perfetti's technique) might be better helped for recovery of upper extremity function in stroke than conventional therapy.

Eligibility criteria: Inclusion Criteria:

* First ever stroke
* Impaired upper extremity function
* Given signed inform consent

Exclusion Criteria:

* Unstable medical condition
* Any upper extremity functional impairment prior to stroke
* Can not adequately cooperate in training
* Severe communication problems
* Severe cognitive - perceptual deficits
* Fixed contracture more than 30 degree in every upper extremity joint

Primary outcomes:
measure: Action research arm test
timeFrame: 4 weeks
Secondary outcomes:
measure: Box and block test
timeFrame: 4 weeks.
measure: Extended Barthel Index
timeFrame: 4 weeks.
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Prasat neurological institute
Study officials:
affiliation: Prasat Neurological Institute
name: Ratanapat Chanubol, MD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wongphaet P, Butrach W, Sangkrai S, Jitpraphai C. Improved function of hemiplegic upper extremity after cognitive sensory motor training therapy in chronic stroke patients: preliminary report of a case series. J Med Assoc Thai. 2003 Jun;86(6):579-84.
citation: Duncan PW, Goldstein LB, Horner RD, Landsman PB, Samsa GP, Matchar DB. Similar motor recovery of upper and lower extremities after stroke. Stroke. 1994 Jun;25(6):1181-8. doi: 10.1161/01.str.25.6.1181.
citation: Lyle RC. A performance test for assessment of upper limb function in physical rehabilitation treatment and research. Int J Rehabil Res. 1981;4(4):483-92. doi: 10.1097/00004356-198112000-00001. No abstract available.