louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00954330: Surgical Versus Functional Treatment for Acute Ruptures of the Lateral Ligament Complex of the Ankle in Young Males - A Randomized Controlled Trial With a Mean of 14 Years Follow-up
Official title: Surgical Versus Functional Treatment for Acute Ruptures of the Lateral Ligament Complex of the Ankle in Young Males - A Randomized Controlled Trial With a Mean of 14 Years Follow-up
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ankle Injury
Keywords: rct, intervention, surgery, lateral ligament injury of the ankle
REturn to pre-injury level
Lead sponsor: Finnish Defense Forces
Sponsor class: OTHER_GOV
First posted: 2009-08-07
Enrollment: 51
Sex: MALE
Minimum age (years): 19
Maximum age (years): 25
Standard ages: ADULT
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: The aim of this prospective randomized controlled trial was to compare the effectiveness of surgical and conservative treatment in acute lateral ligament injury of ankle. The more detailed aims were to assess the function, physical activity level, re-injuries, objective stability and radiographic changes seen by magnetic resonance imaging in patients randomized to surgery or to functional treatment after a mean of 14 years follow-up.


Eligibility criteria: Inclusion Criteria:

* The inclusion criteria included positive stress radiographs (in all cases) and arthrography 15 (5 cases) proven fibulotalar anterior (FTA) and fibulocalcanear (FC) ligament injury.
* The positive findings for a lateral ligament injury included a clinically unstable ankle and a radiological talar tilt \>6 degrees or ADS \>5 mm compared with the uninjured opposite ankle.

Exclusion Criteria:

* The exclusion criteria for the study were diabetes, inflammatory arthritis, previous severe trauma, pre-existing instability of joints.
* In addition, patients were excluded from our study if they had previously undergone surgery of the ankle region.

Primary outcomes:
measure: The main outcome measure in the present study was a validated ankle injury scoring scale, A Performance Test Protocol and Scoring Scale for the Evaluation of Ankle Injuries.
Secondary outcomes:
measure: Return to pre-injury level in physical activity, re-injuries of the same ankle, visits to physician due to the same ankle, range of joint motion, subjective satisfaction and complications were measured
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Central military hospital
Study officials:
References:
Clinical trial NCT02441530: Effectiveness of Vitamin D in Primary Dysmenorrhoea
Official title: Vitamin D in the Treatment of Primary Dysmenorrhoea: A Prospective Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Primary Dysmenorrhoea
Keywords: vitamin D
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
Collaborators: name: Seda Ates
name: Osman Sevket
name: Mucize Ozdemir
name: Gulsah Ilhan
name: Yildirim, Zeynep Baysal, M.D.
First posted: 2015-05-12
Enrollment: 143
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Vitamin D in the treatment of primary dysmenorrhoea. Design:Randomised controlled trial. Setting:In a university hospital. Population: 142 women aged 16-35 years. Methods: Patients were treated with 667 unit of vitamin D once a day, 200 unit of vitamin E once a day or 400 mg ibuprofen twice a day,2 days before the date of menstruation and continued through the first 3 days, for 2 months. Main outcome measures: Pain score. Results: Mean VAS of vitamin D group was 4,91, was 6,54 in the vitamin E group and was 4,02 in the ibuprofen group Conclusion:Vitamin D and vitamin E are effective in relieving the pain,but the effect of vitamin D are more prominent

Detailed description: An excessive uterine production of prostaglandins is the pathogenic trigger of dysmenorrhoea. Nonsteroidal anti-inflammatory drugs (NSAIDs) are the currently accepted drugs for the management of this disorder. The capacity for synthesizing vitamin D and the presence of vitamin D receptor in human cycling endometrium have also been demonstrated. Because vitamin D reduces the synthesis of prostaglandins, a beneficial effect of vitamin D for the uterus is possible.Vitamin E inhibits the release of arachidonic acid and the conversion of arachidonic acid to prostaglandin via an action on the enzymes phospholipase A2 and cyclooxygenase.

Eligibility criteria: Inclusion Criteria:

1. Women had regular menstrual cycles lasted 21 to 35 days, with menstruation lasting 3 to 7 days;
2. Women had to be in good health and taking no medications including calcium, magnesium, vitamin D and oral contraceptives.
3. Women had not a previous history of gynaecological disease, and a normal pelvic examination were eligible.

Exclusion Criteria:

1) Previous and current use of intrauterine contraceptive devices within the 6 months to enrollment was not permitted

Primary outcomes:
measure: pain score ,make a mark on a 10-cm visual analog scale (VAS)
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02585830: Sleep Timing and Insulin Resistance in Adolescents With Obesity
Official title: Investigating the Relationship Between Circadian Phase and Insulin Resistance in Obese Adolescents
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2015-10-23
Enrollment: 25
Sex: ALL
Minimum age (years): 15
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adolescents with obesity

Brief summary: This study examines the relationship between sleep timing and insulin resistance in adolescents with obesity. The investigators also aim to develop a physiologically-based mathematical model of adolescent sleep/wake and circadian interactions.


Eligibility criteria: Inclusion Criteria:

* High school students between the ages of 15-19
* BMI \> 90th percentile
* Tanner stage 2 or greater

Exclusion Criteria:

* Any medications that affect insulin resistance or sleep (e.g., metformin, hormonal contraception, stimulants, atypical antipsychotics)
* Regular use of melatonin or sleep aids
* A prior diagnosis of obstructive sleep apnea, diabetes (HbA1c \> 6.5), liver disease other than non-alcoholic fatty liver disease, pregnancy or breastfeeding
* IQ \< 70 or severe mental illness that may impact sleep (e.g., schizophrenia, psychotic episodes)
* Not enrolled in a traditional high school academic program (e.g., home school students)
* Night shift employment
* Travel across more than 2 time zones in the month prior to the study

Primary outcomes:
measure: Dim Light Melatonin Onset and Offset
timeFrame: 1 day
measure: Insulin Sensitivity
timeFrame: 3 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus/Children's Hospital Colorado
state: Colorado
Study officials:
affiliation: University of Colorado Denver & Children's Hospital Colorado
name: Stacey L Simon, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Simon SL, McWhirter L, Diniz Behn C, Bubar KM, Kaar JL, Pyle L, Rahat H, Garcia-Reyes Y, Carreau AM, Wright KP, Nadeau KJ, Cree-Green M. Morning Circadian Misalignment Is Associated With Insulin Resistance in Girls With Obesity and Polycystic Ovarian Syndrome. J Clin Endocrinol Metab. 2019 Aug 1;104(8):3525-3534. doi: 10.1210/jc.2018-02385.
Clinical trial NCT04958330: Lateral Prostate Capsule Sparing Versus Non Nerve Sparing Robot-assisted Radical Cystectomy-orthotopic Ileal Neobladder for Bladder Cancer in the Male
Official title: Lateral Prostate Capsule Sparing Versus Non Nerve Sparing Robot-assisted Radical Cystectomy-orthotopic Ileal Neobladder for Bladder Cancer in the Male
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bladder Cancer
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
Collaborators: name: First Affiliated Hospital, Sun Yat-Sen University
name: Third Affiliated Hospital, Sun Yat-Sen University
name: The Seventh Affiliated Hospital of Sun Yat-sen University
First posted: 2021-07-12
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Enroll patients who received RARC.

Brief summary: To compare the perioperative, functional, and oncologic outcomes between non nerve sparing and lateral prostate capsule sparing robot-assisted radical cystectomy with orthotopic ileal neobladder in male patients with bladder cancer.

Detailed description: This study will enroll male patients with bladder cancer who will undergo robot-assisted radical cystectomy with orthotopic ileal neobladder. The patients will be distributed into two comparable groups according to surgical procedures: non nerve sparing group and lateral prostate capsule sparing group. Patient demographics and pathologic, perioperative, functional, and oncologic outcomes will be compared between the two groups.

Eligibility criteria: Inclusion Criteria:

1. Male patients aged 18 or older.
2. Patients those who are diagnosed with urothelial carcinoma.
3. Patients those who are without tumour in the bladder neck or urethra, and prostate cancer was ruled out by MRI and serum T-PSA\<2.5ng/ml.
4. Patients those who are capable of receiving radical cystectomy with orthotopic ileal neobladder.
5. Patients those who are able to cooperate and complete the follow-up.
6. Patients those who volunteer to participate in this study and sign the informed consens.

Exclusion Criteria:

1. Patients thsoe who are diagnosed distant metastasis before surgery.
2. Patients those who are diagnosed with other malignancies.
3. Patients those who had received pelvic radiotherapy or major pelvic operation.

Primary outcomes:
measure: day-time and night-time continence rate
timeFrame: 6 months
measure: postoperative sexual function
timeFrame: 6 months
Secondary outcomes:
measure: perioperative complication rate
timeFrame: 3 months
measure: operative time
timeFrame: 24 hours
measure: estimated blood loss
timeFrame: 24 hours
measure: overall survival
timeFrame: 1 year
measure: recurrence-free survival
timeFrame: 1 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Jian Huang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01430130: Investigation of a Novel Silicone Dressing to Maximize the Outcomes of Scar Revision Procedures (IMPROVE)
Official title: Investigation of a Novel Mechanomodulating Polymer to Maximize the Outcomes of Scar Revision Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertrophic
Keywords: scar
incision
wound healing
scarring
scar revision
Lead sponsor: Neodyne Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2011-09-07
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Neodyne has developed an investigational dressing for post-operative incision care. Neodyne is conducting this research to study whether the investigational dressing, called the Neodyne Dressing, can minimize scar formation in a simple manner.

Detailed description: It is proposed to study a dressing designed to reduce the appearance of scars after scar revision surgery. It is expected that by managing the incision site after primary closure but during the longer term healing phase, scar formation may be minimized.

Eligibility criteria: Inclusion Criteria:

* The scar to be revised is:

  * at least 12 months old
  * linear and suitable for revision by excision and direct closure
  * appropriate size and location for Neodyne Dressing
* The subject:

  * age \> 18 and \< 65 years old

Exclusion Criteria:

* Subjects with a skin disorder that is chronic or currently active.
* Subjects who are involved in ongoing litigation in connection with the scar to be revised.
* Subjects with a history of collagen vascular disease
* Subjects diagnosed with scleroderma
* Subject who currently smokes
* Subjects with known adverse reactions to steri-strip tapes, medical tapes, or adhesives
* Subjects with oozing, dehiscence, non-closed/healed incisions at time of first application.
* Subjects with inability to maintain adequate care of incision.

Primary outcomes:
measure: Visual Analogue Scale (VAS)
timeFrame: 6 months
Secondary outcomes:
measure: Subject and Investigator Satisfaction With the Aesthetic Results
timeFrame: Up to 12 months
measure: Ease of Use
timeFrame: Up to 12 months
measure: Comfort Level Related to Study Device Application, Wear and Removal
timeFrame: Up to 12 weeks
measure: Comparison of Scar Smoothness of Treated Side as Compared to the Control Side
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Duet Plastic Surgery
state: California
Study officials:
affiliation: Duet Plastic Surgery
name: Jennifer Weintraub, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duet Plastic Surgery
name: Angeline Lim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01834430: Effects of Delayed Enteral Nutrition on Inflammatory Responses and Immune Function Competence in Critically Ill Patients With Prolonged Fasting
Official title: Effects of Delayed Enteral Nutrition on Inflammatory Responses and Immune Function Competence in Critically Ill Patients With Prolonged Fasting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Severe Acute Pancreatitis Patients
Duodenal Fistula
Inflammatory Intestinal Obstruction
Lead sponsor: Nanjing PLA General Hospital
Sponsor class: OTHER
First posted: 2013-04-17
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Different studies suggest that early enteral nutrition (EEN) has benefits in reducing infectious complications, there is no data that addresses whether delayed enteral nutrition (EN) is detrimental and if it may have effects on inflammatory responses and immune function.


Eligibility criteria: Inclusion Criteria:

* having a fasting time of more than 14 days
* American Society of Anesthesiologists (ASA) physical status ranging between 1 and 3, and their condition allows enteral nutrition therapy.

Exclusion Criteria:

* chronic renal failure (peritoneal or hemodialysis or creatinine \> 2.5 mg/dl)
* history of chronic obstructive pulmonary disease
* hepatic dysfunction or cirrhosis or a bilirubin value \> 3 mg/dl
* metabolic diseases,severe anemia
* blood coagulation dysfunction
* pregnancy lactation
* history of psychiatric illness
* patients underwent immunosuppressive therapy

Primary outcomes:
measure: all cause mortality
timeFrame: 28 days
Secondary outcomes:
measure: organ failure
timeFrame: 7 days
Other outcomes:
measure: inflammatory markers
timeFrame: 7 days
Locations:
Study officials:
References:
Clinical trial NCT06583330: A Multicenter, Open-Label, Non-Inferiority Randomized Controlled Trial of Postoperative VTE Prevention in Chinese Patients After Colorectal Cancer Surgery
Official title: A Multicenter, Open-Label, Non-Inferiority Randomized Controlled Trial of Postoperative VTE Prevention in Chinese Patients After Colorectal Cancer Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Colorectal Surgery
VTE (Venous Thromboembolism)
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
First posted: 2024-09-04
Enrollment: 1448
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: research objective

1. Optimize VTE prevention management after CRC surgery.
2. Improve the prevention and treatment level of VTE in current perioperative patients.
3. Reduce the social burden of VTE related diseases.

Participants will:

1. start low molecular weight heparin prophylaxis within 24 hours post-surgery.
2. The prophylactic regimen for the experimental group lasted 14 days, while the control group received it for 28 days. Low molecular weight heparin is given subcutaneously at a dose of 0.3ml once daily.
3. atients underwent lower limb color Doppler ultrasound on postoperative days 7 ± 2, 14 ± 3, and 28 ± 5, which included screening for thrombosis in the proximal deep veins (femoral, popliteal), distal deep veins (posterior tibial, fibular, and muscular veins), and their perforating branches.


Eligibility criteria: Inclusion Criteria:

* Age\&gt;18 years old; Diagnosed with colorectal cancer and undergoing curative, palliative, or other limited surgeries (laparoscopic or open surgery), with an estimated surgery time of\&gt;45 minutes; Expected postoperative survival\&gt;6 months; Expected Caprini score of ≥ 5 on the first day after surgery; The patient agrees to the research plan and signs an informed consent form.

Exclusion Criteria:

* Renal dysfunction (CrCl\&lt;30 mL/min) or liver dysfunction (ALT\&gt;3 times the upper limit of normal); Known allergies to LMWH, anesthetics, or contrast agents; There is a systemic bleeding disorder or bleeding tendency, such as active peptic ulcer, uncontrolled hypertension, cerebral thrombosis within 6 months, cerebral hemorrhage, or a history of neurosurgical surgery; Known brain metastases, endocarditis, or previous heparin induced thrombocytopenia; VTE occurred within 3 months before surgery; Use heparin or oral anticoagulant therapy within 5 days before surgery; Pregnant or lactating women; Pregnant or lactating women; Any conditions that researcher determines the subject not suitable for anticoagulant therapy.

Primary outcomes:
measure: VTE events, including deep vein thrombosis (DVT) and pulmonary thromboembolism (PE).
timeFrame: From enrollment to the end of treatment at 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04814030: Transarterial Infusion of PD-1 Antibody Plus TACE-HAIC for Unresectable HCC: a Single-arm, Phase 2 Clinical Trial
Official title: Transarterial Infusion of PD-1 Antibody Plus Chemoembolization and FOLFOX-based Chemtherapy for Unresectable BCLC C Stage HCC: a Single-arm, Phase 2 Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Hepatocellular Carcinoma
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2021-03-24
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Trans hepatic arterial infusion of PD-1 antibody, chemoembolization and FOLFOX-based chemotherapy
Primary purpose: TREATMENT

Brief summary: Hepatocellular carcinoma (HCC) is a common disease in East Asia. Less than 20% of newly diagnosed patients can undergo radical resection. For those with unresectable BCLC C stage, transarterial chemotherapy and targeted therapy are recommend to prolong survival. Recently, FOLFOX (Oxaliplatin and 5-fluorouracil) based hepatic artery infusion chemotherapy (HAIC) exhibited high response rate for unresectable HCC. Transartery infusion of agents provide promising outcome when compared systemic infusion. Furthermore, our pilot study showed TACE combined HAIC (TACE-HAIC) had better tumor response, with low progression disease rate. Whether TACE-HAIC plus hepatic artery infusion PD-1 antibody would improve survival for unresectalbe BCLC C stage patients is still unknown. A single arm, phase 2 clinical trial is aimed to answer this question.


Eligibility criteria: Inclusion Criteria:

* BCLC C stage with unresectable diseasehigh-recurrence risk factor;
* Child-Pugh A or B (7 score) liver function;
* Anticipated survival more than 3 moths

Exclusion Criteria:

* Pregnant woman or sucking period;
* With other malignant cancer;
* Received anti-HCC therapy before this study

Primary outcomes:
measure: overall response rate
timeFrame: 12 month
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
References:
Clinical trial NCT00663130: Evaluating the Efficacy Vardenafil 10 mg vs Tadalafil 10 mg in in Subjects With Erectile Dysfunction (ED)
Official title: A Randomised, Double-blind, Double-dummy, Parallel-group, Active-controlled Study Evaluating the Efficacy of Vardenafil Versus Tadalafil When Intercourse is Attempted Within 45 Minutes of Administration in Subjects With Erectile Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Erectile Dysfunction
Keywords: Erectile Dysfunction
Vardenafil
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2008-04-22
Enrollment: 759
Sex: MALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluating the efficacy of 10mg vardenafil versus 10mg tadalafil in the first 45 minutes post-dosing, in an as-required regimen for 4 weeks in subjects with mild/moderate to severe ED


Eligibility criteria: Inclusion Criteria:

* Age between 18 and 64 years
* Heterosexual males
* Erectile dysfunction for more than 6 months

Exclusion Criteria:

* Penile anatomical abnormalities
* Spinal cord injury
* History of surgical prostatectomy

Primary outcomes:
measure: Sexual Encounter Profile Question 3 (SEP-3)
timeFrame: 4 weeks
Secondary outcomes:
measure: Sexual Encounter Profile Question 2 (SEP-2)
timeFrame: 4 weeks
measure: International Index of Erectile Function
timeFrame: 4 weeks
measure: Global Confidence Question (GCQ)
timeFrame: 4 weeks
measure: Erection Quality Scale (EQS)
timeFrame: 4 weeks
measure: General Safety
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: