louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03942380: Cell-free Tumor DNA in Head and Neck Cancer Patients
Official title: Cell-free Tumor DNAand HPV-DNA in Blood Samples From Newly Diagnosed Patients With Head and Neck Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Head and Neck Cancer
Head and Neck Neoplasms
Head and Neck Squamous Cell Carcinoma
Oropharynx Cancer
Oropharynx Neoplasm
Oropharynx Carcinoma
Oral Cavity Cancer
Oral Cancer
Oral Neoplasm
Larynx Cancer
Larynx Carcinoma
Larynx Neoplasm
Nasopharyngeal Carcinoma
Nasopharyngeal Cancer
Nasopharynx Neoplasm
Hypopharynx Cancer
Hypopharynx Neoplasm
Hypopharynx Carcinoma
Sinonasal Carcinoma
Thyroid Carcinoma
Thyroid Cancer
Thyroid Neoplasms
Salivary Gland Cancer
Salivary Gland Neoplasms
Salivary Gland Carcinoma
Sinonasal Cancer
Sinonasal Neoplasm
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Copenhagen University Hospital, Denmark
name: Department of Otorhinolaryngology, Head and Neck Surgery and Audiology
First posted: 2019-05-08
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: DIAGNOSTIC

Brief summary: This study investigates if head and neck squamous cell carcinoma can be tracked with cell-free tumor DNA, RNA or HPV-DNA, in blood samples from patients referred with suspicion of cancer, and if it can be used in detecting recurrence in patients already diagnosed and treated for head and neck squamous cell carcinoma.


Eligibility criteria: Inclusion Criteria:

* Patients 18 years old or older
* Suspicion of head and neck cancer

Exclusion Criteria:

* Diagnosed with cancer within the last 3 years ( apart from basal cell carcinoma)
* Diagnosed with an inflammatory or haematological disease after the age of 18
* Received chemotherapy or immunosuppressive treatment within the last 3 years
* Underwent a FNA ( fine-needle aspiration biopsy) or a biopsy from the head and neck region within 1 week.

Primary outcomes:
measure: Percentage of head and neck cancer detected with a blood sample
timeFrame: 0 months
measure: Percentage of head and neck cancer recurrence detected with a blood sample
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: University Hospital of Copenhagen, Rigshospitalet
state: Region Hovedstaden
Study officials:
affiliation: Department of Otorhinolaryngology, Head and Neck Surgery and Audiology
name: Christian Von Buchwald, MD, DMSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03530280: Effect of Pregabalin or Adductor Canal Block on Postoperative Analgesia
Official title: Effect of Pregabalin or Adductor Canal Block on Postoperative Analgesia After Arthroscopic Anterior Cruciate Ligament Reconstruction (ACL)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain After Knee Arthroscopy
Keywords: pregabalin
adductor canal block
postoperative pain
Lead sponsor: Ankara Diskapi Training and Research Hospital
Sponsor class: OTHER
First posted: 2018-05-21
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: arthroscopically Anterior Cruciate Ligament Reconstruction (ACL) under spinal anesthesia were included in this study.

Detailed description: Patients who American Society of Anesthesiologists (ASA) classification I to II scheduled to undergo arthroscopically assisted ACL reconstructions under spinal anesthesia are included in this study. The first group is administered 150 mg oral pregabalin 1 hour before surgery and the postoperative sham block was performed with an ultrasound probe. The second group is the control group; patients in this group are administered a placebo capsule 1 hour before surgery and sham block was performed with an ultrasound probe.The third group is administered a placebo capsule 1 hour before surgery and postoperative adductor canal block is performed. All patients will be received postoperative a tramadol i.v. patient control analgesia device. At the end of 24 hours, the total amount of tramadol consumed by the patient will be recorded from the patient control analgesia. NRS score, white fast track, satisfaction will be questioned.

Eligibility criteria: Inclusion Criteria:

* Patients between the ages of 18 and 70 years
* American Society of Anesthesiologists I or II
* Scheduled to undergo knee arthroscopy

Exclusion Criteria:

* allergic to any medicines
* History of drug or alcohol abuse,
* Opioids or sedative medications
* History of psychiatric conditions
* Pregnant or lactating women

Primary outcomes:
measure: 11-point numerical rating scale (NRS)
timeFrame: 24 hours
measure: tramadol consumption
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Diskapi Teaching and Research Hospital
state: Altindag
Study officials:
References:
Clinical trial NCT03396380: Effect of Vitamin D Supplement in Induction of Ovulation in Overweight Women With Polycystic Ovary Syndrome
Official title: Effect of Adding Vitamin D Supplement to Clomiphene Citrate for Induction of Ovulation in Overweight Women With Polycystic Ovary Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Ovulation Induction
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2018-01-11
Enrollment: 186
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this work is to evaluate the effect of vitamin D supplementation in overweight infertile women with PCOs undergoing induction of ovulation.

Detailed description: The study will include overweight infertile women with PCOS seeking fertility who will receive induction of ovulation by clomiphene citrate will be recruited and randomized into two groups:

Group A (study group): 93 women who will receive clomiphene citrate for induction of ovulation with vitamin D and calcium supplement

Group B (control group): 93 women who will receive clomiphene citrate for induction of ovulation with placebo and calcium supplement

Eligibility criteria: Inclusion Criteria:

* polycystic ovarian syndrome diagnosis made according to ESHRE/ASRM criteria.
* infertility is the cause for seeking treatment.
* overweight females with BMI more than 25 but less than 30.

Exclusion Criteria:

* causes of infertility other than PCOS.
* causes of anovulation other than PCOS.
* current or in last six months use of hormonal treatment.
* contraindication to any drug used in the study.

Primary outcomes:
measure: Rate of ovulation
timeFrame: till cycle day 21 if not reaching more than 18 mm
Secondary outcomes:
measure: Number of growing follicles.
timeFrame: till cycle day 21 if not reaching more than 18 mm
measure: Evaluation of the endometrial thickness
timeFrame: in cycle day 14 and 21.
measure: Pregnancy rates
timeFrame: pregnancy test 1 week after missed menses
measure: Adverse effects
timeFrame: for 3 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: AinShams university maternity hospital
state: Abbassya
Study officials:
References:
citation: Rasheedy R, Sammour H, Elkholy A, Salim Y. The efficacy of vitamin D combined with clomiphene citrate in ovulation induction in overweight women with polycystic ovary syndrome: a double blind, randomized clinical trial. Endocrine. 2020 Aug;69(2):393-401. doi: 10.1007/s12020-020-02315-3. Epub 2020 May 3.
Clinical trial NCT04515680: Endocrine Function During Deferasirox Therapy
Official title: National Survey on Endocrine Function and Bone Metabolism in Transfusion--dependent Patients Treated With Deferasirox
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Iron Overload
Transfusion-dependent Thalassemia
Endocrine; Complications
Lead sponsor: University of Campania Luigi Vanvitelli
Sponsor class: OTHER
First posted: 2020-08-17
Enrollment: 426
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: All consecutive patients visited at the participating sites since September 2009 were recruited into the cohort provided the inclusion criteria were met: affected by TDT and on deferasirox monotherapy during the study period.

Brief summary: A national survey on the prevalence and natural history of endocrine complications in thalassemia transfusion--dependent patients treated with deferasirox was designed, in order to assess a larger population during a longer follow up and improve the quality of previous investigations.


Eligibility criteria: Inclusion Criteria:

* Adult and pediatric patients with transfusion---dependent thalassemia;
* Chelation with deferasirox as assigned chelation therapy;
* Available medical history including relevant clinical data (age at start of transfusion regimen, age at start of chelation therapy, prior chelation therapy, concomitant diseases and concomitant treatments, including hormonal replacement treatments if appropriate) and laboratory data (e.g TSH, FT3 and FT4, fasting serum glucose, OGTT serum glucose, bone mineral density z---score, T---score, g/cm2, PTH, FSH, LH, testosterone and estradiol, serum ferritin, liver function tests,renal function tests, MRI T2\* value) at baseline and at the end of study

Exclusion Criteria:

* Non transfusion- dependent patients;
* Other chelation therapy than deferasirox or combination with other chelators during the observation;
* Absence of complete medical history as above specified

Primary outcomes:
measure: Change from baseline number of endocrine disorders at study completion
timeFrame: baseline through study completion, a minimum of 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Università degli Studi della Campania Luigi Vanvitelli
Study officials:
References:
Clinical trial NCT05272280: US Guided EOI Block Versus ESPB for Postoperative Analgesia in Laparoscopic Cholecystectomy
Official title: Ultrasound Guided External Oblique Intercostal (EOI) Block Versus Erector Spinae Plane Block (ESPB) for Postoperative Analgesia in Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postoperative Pain
Keywords: Cholecystectomy
EOI block
ESP block
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-03-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To compare the efficacy of USG-guided bilateral External oblique intercostal (EOI) block with Erector spinae plane block (ESPB) for post-operative analgesia after laparoscopic cholecystectomy with a hypothesis that both External oblique intercostal fascial plane block and Erector spinae plane block are effective in providing post-operative analgesia.


Eligibility criteria: Inclusion Criteria:

* Age between 18 and 65 years with a body mass index (BMI) of 18-35 kg/m2,
* patients with the American Society of Anesthesiologists (ASA) physical status I/II,
* Patients scheduled for elective laparoscopic cholecystectomy.

Exclusion Criteria:

* Allergy to local anaesthetics,
* Infection at the site of injection,
* Coagulopathy,
* Chronic pain syndromes,
* Prolonged opioid medication,
* Patients who received any analgesic 24 h before surgery.

Primary outcomes:
measure: Nalbuphine consumption in mg equivalent to morphine dose.
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: Numerical Rating Scale (NRS) at rest and when coughing
timeFrame: at 1, 2,4 , 8, 16 and 24 hours postoperatively
measure: Analgesic drug consumption other than nalbuphine
timeFrame: 24 hours postoperatively
measure: Heart Rate
timeFrame: Intraoperatively at 0, 5,10, 20, and 30 minutes. Then every 15 min thereafter till the end of surgery
measure: Mean Arterial Pressure
timeFrame: Intraoperatively at 0, 5,10, 20, and 30 minutes. Then every 15 min thereafter till the end of surgery
measure: Incidence of Postoperative nausea & vomiting (PONV)
timeFrame: 24 hours postoperatively
measure: Shoulder pain
timeFrame: 24 hours postoperatively
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University hospital
state: Assiut, Asyut Governorate, Egypt,
Study officials:
References:
Clinical trial NCT03151980: The Use of Sun Protection After Hamam (Turkish Bath)
Official title: The Use of Sun Protection After Hamam (Turkish Bath): a Randomized, Controlled, Blinded Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: No Medical Condition
Lead sponsor: Herlev and Gentofte Hospital
Sponsor class: OTHER
First posted: 2017-05-12
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Each participant will be randomized to receive Hamam on either the left or the right side of the back. The other side will be left untreated. Each individual will thereafter receive a sun exposure of both the Hamam-treated skin and the untreated skin.
Primary purpose: OTHER

Brief summary: Hamam is a common spa treatment. During a Hamam, some of the outermost layer of the skin is removed. The investigators believe that partly removing a protective skin layer might increase the risk of sun burn, especially for skin that has not been exposed to sun for a long time.

The aim with this study is to assess if Hamam-treated skin is more susceptible to sun burn compared with untreated skin.


Eligibility criteria: Inclusion Criteria:

* ≥18 years
* Healthy volunteers
* Skin types 1,2,3- Fitzpatrick scale
* Provided informed consent

Exclusion Criteria:

* Regular medication for a condition/disease
* Active skin disease
* Sun exposure on the back within four weeks prior to the start of the study
* History of premalignant or malignant skin lesions
* Tattoo covering more than half of the back

Primary outcomes:
measure: Skin erythema
timeFrame: Baseline until 24 hours after sun exposure.
Secondary outcomes:
measure: Skin erythema
timeFrame: Baseline until 24 hours after sun exposure.
measure: Pain
timeFrame: Baseline until 24 hours after sun exposure.
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Herlev and Gentofte Hospital
Study officials:
affiliation: University of Copenhagen, Herlev Hospital
name: Jacob Rosenberg, Professor
role: STUDY_CHAIR
affiliation: University of Copenhagen, Herlev Hospital
name: Stina Öberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05120180: Effect of ALND With Vein Branches Reservation on Postoperative Upper Limb Edema and Dysfunction in Breast Cancer
Official title: Postoperative Upper Limb Edema and Dysfunction Generated by Axillary Nodes Excision With or Without Axillary Vein Branches Reservation in Breast Cancer Patients: a Prospective, Multiple-center, Double-blinded, Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer Lymphedema
Keywords: Breast Cancer
Axillary Lymph Node Dissection
Post-mastectomy Lymphedema
Upper Limb Dysfunction
Axillary Vein Branches Reservation
Lead sponsor: Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Sponsor class: OTHER
First posted: 2021-11-15
Enrollment: 258
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the effects of axillary lymph node dissection with or without axillary vein branches reservation on the affected upper limb edema and dysfunction in breast cancer patients, and to explore the solutions to prevent the affected upper limb edema and dysfunction after ALND.


Eligibility criteria: Inclusion Criteria:

* Age 18-69 years old,
* Regardless of gender,
* Breast masses were diagnosed by histology and pathology, stage II -III.
* Clinical palpation of axillary lymph nodes is positive, or
* Axillary lymph node puncture pathology is positive, or
* The multidisciplinary treatment cooperation group (MDT) recommends axillary lymph node dissection,
* Good physical state score (0-2),
* No severe organ complications,
* No congenital or acquired diseases affecting the normal morphology and functional activities of the upper limbs,
* Informed consent, understanding and compliance with research requirements.

Exclusion Criteria:

* Pregnancy or lactation,
* Inflammatory breast cancer,
* Clinical findings of metastatic lesions,
* Sentinel lymph node biopsy was negative,
* History of upper limb or shoulder, chest, back trauma or surgery,
* Previous history of local radiotherapy,
* History of other tumors,
* Vascular embolic disease,
* Those who are unable to comply with the clinical trial requirements for any reason.

Primary outcomes:
measure: short-term Incidence of lymphedema
timeFrame: 1-, 6-, and 12-month
measure: short-term Incidence of dysfunction
timeFrame: 1-, 6-, and 12-month
Secondary outcomes:
measure: long-term Incidence of lymphedema
timeFrame: 5 yearsye
measure: long-term Incidence of dysfunction
timeFrame: 5 years
Other outcomes:
measure: TFS
timeFrame: 5 years
Locations:
city: Shanghai
country: China
facility: Shanghai Jiao Tong University Affiliated Sixth People's Hospital
state: Shanghai
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
city: Shanghai
country: China
facility: Shanghai Fengxian Central Hospital
Study officials:
affiliation: Shanghai Jiao Tong University School of Medicine
name: XIANGYUN ZONG, M.D., Ph.D.P
role: STUDY_CHAIR
References:
Clinical trial NCT00426062: Free Radical Level in SCC of Tongue Patients Tumor, Serum and Saliva
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Squamous Cell Carcinoma
Keywords: Squamous Cell Carcinoma of Tongue and mouth floor
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2007-01-24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: Study comparing level of free radicals in tumor tissue, blood serum and saliva in patients with Squamous Cell Carcinoma of tongue and mouth floor. Patients with benign fibroma of oral cavity and normal gingiva around extracted lower wisdom tooth are used for control


Eligibility criteria: Inclusion Criteria:

1. Older than 18 years of age.
2. Mentally healthy
3. SCC of Tongue or Mouth Floor
4. Benign Fibroma of Oral Cavity
5. Lower wisdom tooth extraction -

Exclusion Criteria:

1. Younger than 18 years of age
2. Mentally incapacitated

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
Study officials:
affiliation: Sheba Medical Center
name: Alex Dobriyan, DMD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sheba Medical Center
name: Ran Yahalom, DMD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rambam Health Care Campus
name: Rafi Nagler, DMD,MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03292562: A Comparison of Methods of Discontinuing Nasal CPAP in Premature Infants <30 Weeks Gestation
Official title: A Comparison of Methods of Discontinuing Nasal CPAP in Premature Infants <30 Weeks Gestation - a Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Apnea of Prematurity
Respiratory Distress Syndrome
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2017-09-25
Enrollment: 66
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine if among infants \<30 weeks gestational age on nasal continuous positive airway pressure (NCPAP), whether discontinuing CPAP after gradual reduction in continuous positive airway pressure (CPAP) pressure leads to successful weaning off CPAP when compared to discontinuing CPAP without weaning pressure.


Eligibility criteria: Inclusion Criteria:

* All infants \< 30 weeks by dates, on NCPAP therapy, on caffeine 10mg/kg daily
* Meet CPAP stability criteria for ≥ 12hours (CPAP 6 cm water (H2O), FiO2 \</=0.25 and stable (to maintain sats 85-95%), Respiratory rate consistently less than 60, Mild to no subcostal/intercostal retractions, No Apnea or bradycardia event that requires bag mask ventilation, Less than 3 apnea/brady/desat episodes in any 1 hour period for previous 6 hours, Tolerated time off CPAP during routine CPAP care (\~15 min)

Exclusion Criteria:

* Major congenital anomalies including congenital heart disease
* Anomalies that prevent discontinuation of NCPAP
* Undergoing current evaluation for and/or treatment of sepsis

Primary outcomes:
measure: Number of Days on NCPAP or Mechanical Ventilation
timeFrame: from randomization until 28 days post-randomization
Secondary outcomes:
measure: Duration of Endotracheal Ventilation
timeFrame: from randomization until 28 days post-randomization
measure: Number of Participants Who Failed to Wean Off NCPAP
timeFrame: from randomization until discharge (about 92 days)
measure: Number of Participants Who Developed Bronchopulmonary Dysplasia
timeFrame: from randomization until discharge (about 92 days)
measure: Number of Participants Who Developed Necrotizing Enterocolitis
timeFrame: from randomization until discharge (about 92 days)
measure: Number of Days of Life at Which Infant Starting Taking All Feeds by Mouth
timeFrame: from randomization until discharge (about 92 days)
measure: Length of Hospital Stay
timeFrame: from admission to hospital until discharge (about 92 days)
measure: Number of Participants Who Developed Air Leak Disorders
timeFrame: from randomization until discharge (about 92 days)
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Brittany Duyka, MD
role: PRINCIPAL_INVESTIGATOR
References: