louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00016224: Thalidomide in Treating Patients With Refractory or Resistant Epithelial Ovarian Cancer
Official title: Phase II Trial of Thalidomide in Patients With Ovarian Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ovarian Cancer
Keywords: recurrent ovarian epithelial cancer
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-01-27
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: RATIONALE: Drugs such as thalidomide may stop the growth of cancer cells by stopping blood flow to the tumor.

PURPOSE: Phase II trial to study the effectiveness of thalidomide in treating women who have epithelial ovarian cancer that has not responded to previous therapy.

Detailed description: OBJECTIVES:

* Determine the time to progression of disease in patients with platinum-refractory or resistant ovarian epithelial carcinoma treated with thalidomide.
* Evaluate the quality of life of patients treated with this regimen.

OUTLINE: Patients receive oral thalidomide once daily. Treatment continues in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline and then every 4 weeks.

PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study within 9-15 months.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Histologically confirmed ovarian epithelial carcinoma
* Platinum-refractory or resistant disease

  * At least 1 prior non-platinum chemotherapy agent required
* Prior bilateral salpingo-oophorectomy and hysterectomy required
* Bidimensionally measurable disease OR CA-125 greater than 100 units/mm3

PATIENT CHARACTERISTICS:

Age:

* Over 18

Performance status:

* Karnofsky 70-100%

Life expectancy:

* More than 3 months

Hematopoietic:

* Not specified

Hepatic:

* Bilirubin normal
* AST no greater than 2.5 times upper limit of normal (ULN)

Renal:

* Creatinine no greater than 1.5 times ULN OR
* Creatinine clearance at least 50 mL/min

Other:

* No other prior malignancy except non-melanoma skin cancer unless curatively treated with no evidence of disease within the past 5 years and at low risk for recurrence
* No other clinical circumstances that would preclude study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* At least 4 weeks since prior biologic therapy and recovered
* No prior thalidomide

Chemotherapy:

* See Disease Characteristics
* At least 4 weeks since prior cytotoxic therapy and recovered

Endocrine therapy:

* At least 4 weeks since prior hormonal therapy and recovered

Radiotherapy:

* At least 4 weeks since prior radiotherapy

Surgery:

* See Disease Characteristics
* At least 4 weeks since prior major surgery

Primary outcomes:
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: David R. Spriggs, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02250924: Caffeinated Gum to Prevent Post-Operative Ileus: A Prospective, Randomized, Placebo-controlled Trial
Official title: Caffeinated Gum to Prevent Post-Operative Ileus: A Prospective, Randomized, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: C.Surgical Procedure; Digestive System
Lead sponsor: The Guthrie Clinic
Sponsor class: OTHER
First posted: 2014-09-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a randomized, three-arm, double-blind, placebo-controlled, Phase III clinical trial of caffeinated gum and sugar-less gum in adult patients after an abdominal procedure. Patients will be randomized to receive placebo, sugar-less gum or caffeinated gum three times daily for 30 minutes starting the day following surgery until discharge or 24 hours after attainment of the primary endpoint.


Eligibility criteria: Inclusion Criteria:

* Abdominal procedure (Laparoscopic or open, occurring electively), American Society of Anesthesiologists (ASA) physical status score ≤ 3, Glasgow Coma Score (GCS) ≥ 15.

Exclusion Criteria:

* ASA physical status score of \>3, GCS \< 15, complete bowel obstruction, history of cardiac arrhythmia, history of phenylketonuria, alcohol abuse. substance abuse dentures

Primary outcomes:
measure: Mean time to GI function recovery (GI-3)
timeFrame: An expected average of 5 days
Secondary outcomes:
measure: Mean length of postoperative hospitalization
timeFrame: Up to 30 days
measure: Rate of postoperative ileus
timeFrame: Up to 30 days
measure: Adverse event rates
timeFrame: Up to 30 days postoperative
Other outcomes:
Locations:
city: Sayre
country: United States
facility: The Guthrie Clinic
state: Pennsylvania
Study officials:
affiliation: The Guthrie Clinic
name: Karim Sadik, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04850924: Emergency Psychological Intervention With Children: Alex Storm
Official title: Alex Storm: Acute Stress Manifestations' Description in French Pediatric Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psychological Trauma
Lead sponsor: Fondation Lenval
Sponsor class: OTHER
First posted: 2021-04-20
Enrollment: 116
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children aged between 0 to 18 years. Impacted by the Alex Storm and evacuated to Nice airport

Brief summary: Alex storm hits France, especially the French Riviera, from September 30, 2020 to October 3, 2020. A lot of people have been impacted by this event. Among these people, 116 children have been taking care by the medico-psychological emergency unit and have been assessed by child psychiatrists or by psychologists.

Detailed description: Alex storm hits France from September 30, 2020 to October 3, 2020. On October 2, several valley in the Nice hinterland were devastated by this natural disaster. Nine people died during this storm and hundreds of families were affected (house washed away or uninhabitable). This led to emergency evacuations on October 3 of several families. The inhabitants of some villages have been subjected to prolonged stress (lack of water and electricity, difficulty in supplying food, fear of another storm). These villages were isolated for a period varying from fifteen days to over three months. These people are particularly exposed to psychological consequences.

Between October 3 and October 30, the CUMP (medico-psychological emergency unit) was mobilized to provide psychological first aid to these families. Among those seen in emergency 116 children were taken care of. In order to assess the immediate symptoms of the children, the investigators used an assessment sheet specific to the developmental ages of the children.

All children seen in an emergency between October 3 and October 30, 2020 were assessed by child psychiatrists or by psychologists trained in emergency and pediatric psychological trauma.

Eligibility criteria: Inclusion Criteria:

* children impacted by the Alex storm
* children seen in an emergency between October 3 and October 30, 2020
* children were assessed by child psychiatrists or by psychologists trained in emergency and pediatric psychological trauma

Exclusion Criteria:

* children whose parents refused to the processing of their data

Primary outcomes:
measure: measure of risk developing post-traumatic stress disorder
timeFrame: at inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Nice
country: France
facility: Hôpitaux Pédiatriques de Nice CHU-Lenval
Study officials:
References:
citation: Richez A, Gindt M, Battista M, Nachon O, Menard ML, Askenazy F, Fernandez A, Thummler S. Storm Alex: acute stress responses in the pediatric population. Eur J Psychotraumatol. 2022 May 11;13(1):2067297. doi: 10.1080/20008198.2022.2067297. eCollection 2022.
Clinical trial NCT00406224: Effect of Oxygen Breathing on Flicker Induced Blood Flow Changes in the Optic Nerve Head
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2006-12-04
Sex: MALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Background It has recently been shown that diffuse luminance flicker increases retinal and optic nerve head blood flow. This indicates that a neuro-vascular coupling between neural activity and blood flow exists as described previously for the brain. Although a lot of mediators such as NO, pO2, pCO2, H+ and K+ have been proposed, the mechanism of this coupling is still a matter of controversy. However, it has been shown in an animal experiment, that an increase in blood flow, evoked by diffuse luminance flicker stimulation is paralleled by an decrease in pO2 in the tissue. Thus, in this study we set out to investigate the flicker light induced increase in blood flow under elevated blood pO2.

Study rationale The motive for the investigation of retinal blood flow regulation is to enhance our understanding of the coupling mechanism between increased neural activity and blood flow in the retina in order to gain new insight in the pathophysiology of several eye diseases associated with ocular vascular disorders Study objectives To test the hypothesis whether oxygen breathing influences flicker light induced changes in optic nerve head blood flow


Eligibility criteria: Inclusion Criteria:

* healthy volunteers

Exclusion Criteria:

* Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
* Treatment in the previous 3 weeks with any drug
* Symptoms of a clinically relevant illness in the 3 weeks before the first study day
* Blood donation during the previous 3 weeks

Primary outcomes:
measure: Retinal vessel diameters
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Medical University of Vienna
name: Gerhard Garhofer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00328224: Oral Status and Prevalence of Dental Trauma in Children Treated With Ritalin Due to Attention-Deficit Hyperactivity Disorder (ADHD)
Official title: Oral Status and Prevalence of Dental Trauma in Children Treated With Ritalin Due to Attention-Deficit Hyperactivity Disorder (ADHD)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Attention Deficit Disorder With Hyperactivity
Dental Caries
Dental Occlusion, Traumatic
Keywords: ritalin
ADHA
dental status
periodontal status
Attention-Deficit Hyperactivity Disorder
Dental trauma
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2006-05-19
Enrollment: 50
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Sampling method: PROBABILITY_SAMPLE
Study population: healthy children children with adhd treated with ritalin

Brief summary: To evaluate the dental status of children using ritalin and suffering from ADHA in comparison to healthy children.

Detailed description: In this trial oral and dental status of 30 children (ages 5-12) who suffer from ADHD and treated with ritalin will be evaluated. Parameters that will be checked are the following: DMFT - decay, missing, filling teeth for dental status, GI - gingival index, PI - plaque index for periodontal status. OJ - over jet and OB - over bite for inter-maxillary relations and susceptibility for dental trauma. In addition these parameters will be collected for 30 age and sex match healthy children.

Eligibility criteria: Inclusion Criteria:

* children ages 5-12 years healthy children children taking ritalin who suffer from ADHD

Exclusion Criteria:

* all others

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization, Jerusalem, Israel
Study officials:
affiliation: Hadassah Medical Organization
name: Diana Ram, DMD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hadassah Medical Organization
name: Meir Redlich, DMD,PhD
role: STUDY_DIRECTOR
affiliation: Hadassah Medical Organization
name: Hadas Katz-Sagi, DMD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06929624: A Phase 3 Clinical Study of SHR-A1912 Combined With R-GemOx Versus R-GemOx in Diffuse Large B-cell Lymphoma
Official title: A Phase 3, Open-label, Randomized Study of SHR-A1912 Combined With Rituximab + Gemcitabine + Oxaliplatin (R-GEMOX) Versus R-GEMOX in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Diffuse Large B-cell Lymphoma
Lead sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-04-16
Enrollment: 280
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: This is a multicenter, randomized, open-label, phase 3 clinical study to evaluate the efficacy of SHR-A1912 combined with R-GemOx in relapsed refractory diffuse large B-cell lymphoma.


Eligibility criteria: Inclusion Criteria:

1. Histologically confirmed diffuse large B-cell lymphoma (DLBCL).
2. Have received ≥1 line of systemic antitumor therapy.
3. At least one bi-dimensionally measurable lesion.
4. Expected survival of at least 3 months.
5. Age ≥18 years old and under 80 years old.
6. The patients voluntarily participated in the study, signed informed consent, had good compliance and were willing to cooperate with follow-up.

Exclusion Criteria:

1. Central nervous system lymphoma involvement.
2. Primary mediastinal (thymus) large B-cell lymphoma.
3. Patients who have only one prior line therapy and are candidates for stem cell transplantation.
4. A history of immunodeficiency.
5. A history of severe cardiovascular disease.
6. A history of other malignancies within 5 years prior to administration of the first dose.

Primary outcomes:
measure: Complete response rate (CRR)
timeFrame: Up to 1 years following the first dose of the last enrolled patient.
measure: Overall survival (OS)
timeFrame: Up to 5 years following the first dose of the last enrolled patient.
Secondary outcomes:
measure: Adverse events (AEs)
timeFrame: Up to 5 years following the first dose of the last enrolled patient.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT03409224: Differences in Immunologic Response to Cryoablation Versus Radiofrequency Ablation in the Treatment of Renal Cell Carcinoma
Official title: Differences in Immunologic Response to Cryoablation Versus Radiofrequency Ablation in the Treatment of Renal Cell Carcinoma
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Immune Response to 3 Approaches
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2018-01-24
Enrollment: 53
Sex: MALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients that undergo one of the three treatments for Renal Masses:

* Cryoablation
* Partial Nephrectomy
* Radiofrequency

Brief summary: The purpose of this study is to compare changes in the body's self-defense (immune response) after two different treatments for small kidney tumors: 1) Cryoablation (freezing) therapy in which the tumor and a margin of normal kidney tissue are frozen and thawed twice with a needle probe and 2) radiofrequency ablation (RFA) in which radiofrequency energy delivered through a needle probe is used to heat tissue and thereby destroy a tumor.


Eligibility criteria: Inclusion Criteria:

* You are eligible to participate in this study if you are an adult (older than 18 years)
* Diagnosed with renal cell cancer 1-3 centimeters in size on the CT scan.

Exclusion Criteria:

* You are not eligible to participate in this study if you are immune compromised (chemotherapy,corticosteroid use, HIV \[as documented in your medical record\], etc.)
* Have an autoimmune disorders (Rheumatoid arthritis, Crohn's disease, etc)
* Have a tumor larger than 4 cm
* Are pregnant.

Primary outcomes:
measure: Immune Response to Cryoablation, RFA and Laparoscopic Partial Nephrectomy
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00566124: Basal Insulins - Pharmacodynamics
Official title: No Evidence for Essential Differences Between the Effects of Insulin Glargine, Insulin Detemir and NPH Insulin on Glucose Metabolism After a Single Injection as Assessed by 24-h Euglycemic Clamp Studies in Healthy Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes
Keywords: Levemir, Lantus, Insulatard, Pharmacodynamics, Healthy humans
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: The Danish Diabetes Association
name: The Institute of Experimental Clinical Research, University of Aarhus
name: Novo Nordisk A/S
First posted: 2007-12-03
Enrollment: 10
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To purpose of this study is to compare the pharmacodynamic properties of insulin detemir, insulin glargine and NPH insulin after a single subcutaneous injection.

Detailed description: In this randomized, double-blind, euglycemic glucose clamp study, 10 healthy male volunteers received a subcutaneous injection of 0.4 U/kg insulin detemir, insulin glargine or NPH insulin on three separate study days in a cross-over design. After insulin administration, plasma glucose was maintained at 0.3 mmol/l below fasting level for 24 hours by manually adjusted glucose infusion. C-peptide, insulin, NEFA and counter regulatory hormones were measured throughout the clamp period. Endogenous glucose release (EGR) was assessed by the isotope dilution technique (3-3H-glucose).

Eligibility criteria: Inclusion Criteria:

* Male
* BMI 20 - 50 kg/m2
* Blood pressure \< 140/90 mmHg
* signed informed consent
* Caucasien

Exclusion Criteria:

* Diabetes or other disease
* Alcohol or drug abuse
* Smoking
* Use of prescription drugs

Primary outcomes:
measure: Area under GIR-curve, maximal glucose infusion rate, time to maximal glucose infusion rate.
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Medical department M (Endocrinology and Diabetes), Aarhus University Hospital
state: DK
Study officials:
affiliation: University of Aarhus
name: Ole E. Schmitz, DMSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04291924: Validity and Reliability of a Low-cost Chair Dynamometer
Official title: Validity and Reliability of a Low-cost Chair Dynamometer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Spinal Cord Injuries
Lead sponsor: Spinal Cord Injury Centre of Western Denmark
Sponsor class: OTHER
Collaborators: name: University of Aarhus
First posted: 2020-03-02
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Ablebodied, healthy volunteers

Spinal cord injured individuals admitted at SCIWDK

Brief summary: In part 1 of the study, fourteen able-bodied individuals will undergo maximal, voluntary contraction (MVC) test of the lower limbs in two dynamometers. One being a low-cost dynamometer (S2P-CD), and the other being a gold standard dynamometer (HUMAC). Thereby the investigators will be able to assess the validity of the S2P-CD.

In part 2 of the study, eighteen persons with spinal cord injury will undergo MVC twice in the S2P-CD. Thereby the investigators will be able to assess the reliability of the measurements of the S2P-CD.

Detailed description: In part 1 of the study, fourteen able-bodied individuals will undergo maximal, voluntary contraction (MVC) test of the lower limbs in two dynamometers. One being a low-cost dynamometer (S2P-CD), and the other being a gold standard dynamometer (HUMAC). The tests will be carried out with 72-96 hours between them. Thereby the investigators will be able to assess the validity of the S2P-CD.

In part 2 of the study, eighteen persons with spinal cord injury will undergo MVC twice in the S2P-CD. Participants will be recruited through the Spinal Cord Injury Centre of Western Denmark (SCIWDK). The test will be carried out with 30min between them. Thereby the investigators will be able to assess the reliability of the measurements of the S2P-CD.

Eligibility criteria: Ablebodied individuals:

Inclusion Criteria:

* Age \>18 y

Exclusion Criteria:

* Orthopedic or other injuries that may limit maximal muscle strength

Spinal cord injured individuals:

Inclusion Criteria:

* Age \> 18 y
* Congenital or acquired spinal cord injury with some degree of preserved muscle function in the lower limbs

Exclusion Criteria:

* Orthopedic or other injuries that may limit maximal muscle strength
* Significant competing diseases
* Severe osteoperosis

Primary outcomes:
measure: Maximal voluntary contraction
timeFrame: 15min
Secondary outcomes:
measure: Rate of force development
timeFrame: 15min
Other outcomes:
Locations:
city: Viborg
country: Denmark
facility: Spinal Cord Injury Centre of Western Denmark
Study officials:
affiliation: Spinal Cord Injury Centre of Western Denmark
name: Søren K Jensen, MSc
role: PRINCIPAL_INVESTIGATOR
References: