cyrilzakka/clinical-trials huggingface dataset:
Minoxidil 2% for Eyebrow Enhancement

The purpose of the study is to compare minoxidil 2% versus placebo in enhancement of eyebrows.


Eligibility Criteria:
Inclusion Criteria:

* male or female aged 18-40 years
* hypotrichosis of eyebrows
* healthy
* informed consent obtained

Exclusion Criteria:

* no underlying diseases
* no alopecia areata or trichotillomania
* no thyroid diseases
* no pregnancy or breast feeding
* no previous eyebrow tattoo, trauma or accident.
* no history of eyebrow or hair medications in 6 months
* no history of minoxidil or its ingredient allergy
* no history of eyebrow surgery.
Vocal-cord vs. Complete Laryngeal Radiotherapy for Early Glottic Cancer

This is a multicentrer, randomized Bayesian Phase II trial for patients with early stage (T1N0) glottic squamous cell carcinoma treated with radical radiotherapy. The primary objective is to assess the non-inferiority of local control achieved with vocal-cord only radiotherapy (VC-RT) compared to complete larynx radiotherapy (CL-RT) in T1N0 glottic laryngeal squamous cell cancer, measured at 2-years after treatment. Secondary outcomes include overall survival, as well as voice impairment, dysphagia and quality of life, measured respectively by the voice handicap index -10 (VHI-10), the MD Anderson Dysphagia Inventory (MDADI) and the MD Anderson Symptom Inventory- Head and Neck module (MDASI-HN). Patients will be randomized in a 1:3 ratio to CL-RT (39 patients) and VC-RT (116 patients) arms. There will be stratification by tumor stage (T1a/T1b) and by institution. An interim analysis is planned after the first 55 patients enrolled on the experimental arm have a 6-month follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Stage T1a-b N0 of the true vocal cords planned for definitive RT
* Patient not candidate for laser surgery or declined laser surgery
* Biopsy-confirmed squamous cell carcinoma, including verrucous carcinoma
* Eastern Cooperative Oncology Group performance status 0-2
* Ability to provide written informed consent.

Exclusion Criteria:

* Previous irradiation of the head and neck (HNC) region
* Pregnancy or breastfeeding
* Any medical condition that represents, in the opinion of the investigator, a contraindication to radiotherapy or would prevent follow-up after radiotherapy.
* Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 2 years.
A Study of Neoantigen mRNA Personalised Cancer in Patients With Advanced Solid Tumors

This is a Phase 1 open label study to evaluate the tolerability, safety, immunogenicity, and efficacy of SW1115C3, a neoantigen mRNA personalised cancer vaccine, in patients with advanced malignant solid tumours.


Eligibility Criteria:
Inclusion Criteria:

* Are 18 to 80 years old (including boundary values), without limitation of sex at time of consent.
* Based on the RECIST 1.1 criteria for disease progression, (a maximum increase in tumour diameter of 20%) for participants undergoing prescreening who are receiving standard treatment, these participants may reach the defined disease progression criteria at the time of tumour vaccine administration.

Exclusion Criteria:

* Have used a live attenuated vaccine within 4 weeks before the first use of SW1115C3 with the following exceptions:
* Adverse reactions induced by previous anti-tumour treatments have not yet recovered to Grade ≤ 1 (except for toxicity evaluated to have no risk of safety by the PI \[or designee\], such as hair loss, Grade 2 peripheral neurotoxicity and hypothyroidism stabilised by hormone-replacement therapy) based on NCI CTCAE version 5.0.
Risk of Pneumothorax With and Without Chest Tube Clamping in Patients With Pleural Pathology

Through this randomized controlled clinical trial, we aim to identify whether there is a difference in the incidence of 24 hour pneumothorax after chest tube removal, in two blindly randomized groups of patients: The first group with chest tube clamping 6 hours prior to removal, and the second group there will be no chest tube clamping.

The data will be prospectively collected from patient records from the National Institute of Respiratory Diseases Ismael Cosío Villegas.

Patients with an indication of chest tube removal will be randomized to two possible arms: clamping (for 6 hours before removal) or not clamping (immediate removal).

Incidence of 24hour pneumothorax after chest tube removal will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 16 years and more.
* Patients hospitalized in the National Institute of Respiratory Diseases.
* Patients who had a chest tube placement during their stay at the hospital, by any cause.

Exclusion Criteria:

* Patients who refuse to sign the informed consent and who refuse to participate in the study.
* Patients who die before randomization.
* Patients who gets chest tube removal before being randomized.
Advanced Image Guidance Utilized in Liver Surgery

Advanced Image Guidance for this study was used during laparoscopic microwave ablation surgery to help the surgeon accurately place the ablation needle into the tumor of patients diagnosed with liver cancer.

Hepatocellular carcinoma (HCC) is diagnosed in over 19,000 Americans annually and responsible for 17,000 deaths. Worldwide, (HCC) is the third leading cause of cancer death. Hepatocellular carcinoma recurs frequently due to its multi-centric nature, which requires repeated treatments and often results in progressively fewer treatment options because of severe underlying liver dysfunction. While surgery offers the best prognosis for such tumors and lesions, only 10-15% of all patients are candidates for removal by surgical means, necessitating the exploration of other treatment options. InnerOptic's AIM Guidance System is designed to alleviate the difficulty in using ultrasound to place a needle. AIM shows the needle and the ultrasound slice in their locations in 3D on a stereo monitor, making the spatial relationship between them obvious. AIM also displays the needle trajectory and where the needle will intersect with the ultrasound image, providing the surgeon with an indication of where the needle will go, if inserted along the needle shaft. AIM can also render an ablation volume guide, providing the surgeon with further confirmation that the needle is placed accurately and providing a volumetric guide regarding the power settings of the ablation.

Eligibility Criteria:
Inclusion Criteria:

* Individuals who have hepatocellular carcinoma.
* Individuals who are candidates for microwave ablation surgery.

Exclusion Criteria:

* Individuals who do not have hepatocellular carcinoma.
* Individuals who are not a candidate for laparoscopic microwave ablation surgery.
A Study in Adults to Learn About Inherited Alpha-1 Antitrypsin Deficiency (AATD) and AATD Related Liver Problems

The main aim of this study is to learn about liver problems caused by the lack of alpha-1 antitrypsin (called Alpha-1 Antitrypsin Deficiency or AATD) in adults when not treated (this is called the natural history of a condition) over 5 years. Other aims are to learn what can predict the AATD-liver condition starting and getting better or worse, describe how this condition is currently being diagnosed and watched in normal hospital care, and describe how the AATD also affects and adult's lung function.

Data in this study will be collected to include medical history of a participant, including the date AATD was first identified and/or the date on which the first AATD-related liver or lung problems were diagnosed. At study start and then every year until study end, participants will be asked to completed questionnaires (called patient-reported outcomes or PRO).


Eligibility Criteria:
Inclusion Criteria:

Participants who meet all the following criteria will be included in the study.

Cohorts 1 and 2:

1. Willing to provide written informed consent or currently enrolled in an ongoing participating AATD patient registry that does not require reconsenting to participate in the study.
2. \>=18 years of age at enrollment in this study.
3. Participants with documented diagnosis of AATD, meeting the following criteria:

   1. Cohort 1 (AATD-Pi\*ZZ genotype/phenotype).

      • Pi\*ZZ genotype as documented from rapid genetic assay, sequencing, or polymerase chain reaction (PCR), or Pi\*ZZ phenotype as documented from iso-electric focusing (IEF) electrophoresis.
   2. Cohort 2 (AATD-Pi\*SZ genotype/phenotype with liver disease manifestation).

      * Pi\*SZ genotype as documented from rapid genetic assay, sequencing, or PCR, or Pi\*SZ phenotype as documented from IEF electrophoresis, and
      * Moderate-advanced or severe liver disease manifestation as defined by either liver biopsy or surrogate laboratory measures, as determined through:

        * Lab and imaging measures to define liver disease manifestation

Exclusion Criteria:

Participants who meet any following criteria will be excluded from the study.

1. Documented AATD genotype/phenotype other than Pi\*ZZ or Pi\*SZ.
2. History of liver transplant.
3. No results for either biopsies, magnetic resonance elastography (MRE), fibro scan (vibration controlled transient elastography \[VCTE\]), or Aspartate aminotransferase to platelet ratio index (APRI) in the 24 months prior to the study baseline date, and has none of these tests ordered in the current visit that will be available in the next 90 days.
4. Participants who had previously been treated or in an active participation in an interventional trial studying liver or lung disease.
5. Treatment with liver directed AATD investigational therapy as part of a compassionate use request.
Effects of Perioperative Pregabalin for Post-Craniotomy Pain

Objective: To compare the incidence of chronic pain at 3 months among adults undergoing craniotomy between those received two different doses of pregabalin and those receiving placebo.

Hypothesis: Perioperative pregabalin will reduce the incidence of chronic post-operative pain, and will reduce the opioid consumption, opioid-related side effects, and hospital length of stay compared with placebo in patients undergoing elective craniotomy.

Methods: 316 adults (18-65y), ASA I-III, undergoing elective craniotomy will be randomized to receive: 100mg or 150mg pregabalin or placebo once pre-operatively and 50mg or 75mg or placebo twice daily for 14 post-operative days. NRS pain scores, opioid consumption and side effects will be assessed up to 48h, and long-term pain at days 7, 14, 30, and 90. The primary analysis will involve the comparison between the 2 treatment groups together vs. placebo. A stepwise method will be used to evaluate the pairwise comparisons.

Outcomes: The primary outcome will be the incidence of chronic post-craniotomy pain at 3 mos. Important secondary outcomes are: neuropathic component of pain at 3 mos., total opioid consumption in the first 24h, and incidence and severity of opioid-related side effects at days 1, 2 and 7.

Eligibility Criteria:
Inclusion Criteria:

* Adults, 18 to 65 years (limited to 65 years to lower the risk of over-sedation for elderly patients)
* Undergoing elective craniotomy (supratentorial or infratentorial) under general anaesthesia for: biopsy or resection of a tumour, clipping of an unruptured aneurysm, or excision of an arteriovenous malformation
* ASA physical status I-III

Exclusion Criteria:

* predicted need for prolonged post-operative ventilation (\> 12 hours)
* chronic pain secondary to previous craniotomy
* known adverse reaction to drugs used (gabapentin, pregabalin, hydromorphone, and/or acetaminophen)
* prior use of pregabalin or gabapentin (within 2 weeks before surgery)
* current history of moderate to severe headaches (NRS ≥ 4) related to intracranial pathology (tumour pain) since it may be difficult to discriminate between ongoing tumour pain and surgery-related post-operative pain
* current history of migraines
* pre-existing chronic pain requiring chronic opioid use (30mg morphine equivalent within 4 weeks of surgery)
* currently taking any drug that could interact with pregabalin
* current history of alcohol or recreational drug abuse
* known or suspected addiction to narcotic substances or chronic narcotic use in the last 2 weeks
* history of malignant hyperthermia (contraindicates the anaesthesia protocol of this study)
* history of angioedema
* Body Mass Index ≤ 18.4 or ≥ 35
* history of untreated obstructive sleep apnea
* any condition that would contraindicate the use of patient-controlled analgesia (PCA)
* lacks fluency in English
* pre-existing renal impairment (for pregabalin elimination)
* pregnancy
COVID-19 Infection in Patients With Hepatocellular Carcinoma

Since December 2019, a new disease named COVID-19 linked to a new coronavirus, SARS-CoV2 has emerged in China in the city of Wuhan, Hubei province, spreading very quickly to all 5 continents, and responsible for a pandemic. France is the third most affected country in Europe after Italy and Spain. Groups of patients at a higher risk of developing a severe form of COVID-19 have been defined: this include patients with immunosuppressive disease as cancer or patients with advanced cirrhosis of the liver. Coronavirus liver injury had been described with SARS-CoV 1 and MERS-CoV. There is no data on liver damage associated with COVID-19 infection for compensated or decompensated cirrhotic patients. The objectives of this project are to estimate the incidence of COVID-19 in hepatocellular carcinoma population, both hospital and ambulatory, and to study the impact on the frequency of severe forms, the prognosis, but also liver function, and the management of hepatocellular carcinoma, in this context of pandemic


Eligibility Criteria:
Inclusion Criteria:

* Patients with CHC and included in the French national prospective cohort CHIEF
* Hospital and ambulatory patients
* Infection confirmed by COVID-19 defined by a positive nasopharyngeal PCR or if PCR COVID-19 negative : CT showing COVID-19 compatible pneumonia
* Suspected COVID-19 infection, not confirmed by COVID-19 PCR or chest CT, with no other known cause of acute pneumonia.

Exclusion Criteria:

* Patient refusal
* Influenza only, confirmed by a diagnostic test
* Other proven causes of pneumonia and absence of COVID-19
Combining Motor Imagery and Tendon Vibration on the Effectiveness of Motor Imagery

Kinesthetic motor imagery (kMI) involves imagining the sensations of movement, activating brain regions similar to actual movement execution. It is widely used to maintain or restore motor functions, particularly in rehabilitation. Tendon vibration (TV), which stimulates proprioceptive receptors can also enhance corticospinal excitability and promote neuroplasticity. This project investigates the coupling of kMI and TV through three modalities: simultaneous application, TV application between kMI trials, or pre-application of TV to precondition the nervous system before kMI trials. The effectiveness and quality of kMI will be assessed by corticospinal excitability measurements using transcranial magnetic stimulation and EEG measures. Conducting this study in healthy participants will inform the development of optimized clinical interventions for immobilized or mobility-reduced patients.


Eligibility Criteria:
Inclusion Criteria:

* Men or women aged 18 to 50 years.
* Affiliated with or beneficiaries of a social security system.
* Provided written informed consent freely after being informed of the study's purpose, procedures, and potential risks.

Exclusion Criteria:

* History of pathology or surgery affecting upper limb motor function within 6 months prior to the study.
* Chronic neurological, motor, or psychiatric disorders.
* Use of neuroactive substances likely to alter corticospinal excitability (e.g., hypnotics, antiepileptics, psychotropics, muscle relaxants) during the study period.
* Contraindications to transcranial magnetic stimulation
* Simultaneous participation in another interventional study or participation in such a study within 30 days prior to this study.
Intracorporeal Anastomosis Versus Extracorporeal Anastomosis for Left Colon Cancer

This study aims to investigate the effects of intracorporeal anastomosis and extracorporeal anastomosis in laparoscopic-assisted radical left hemicolectomy on surgical site infection. Also consider perioperative recovery, safety, and oncology outcomes.

This is a prospective, randomized controlled trial. In this trial, cases in the intracorporeal anastomosis group and the extracorporeal anastomosis group are allocated at a 1:1 ratio among patients undergoing laparoscopic radical left hemicolectomy. The peri-operative recovery data, complications, oncology outcomes, and survival are compared.

Eligibility Criteria:
Inclusion criteria

1. age between 18 and 80 years;
2. histologically or cytologically confirmed left-sided colon cancer (distal transverse colon, left colic flexure, descending colon, or proximal sigmoid colon);
3. clinical stage T1-4a, N0-2, and M0;
4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;
5. suitable for laparoscopic colectomy;
6. no previous systemic chemotherapy or radiotherapy;
7. willing to provide written informed consent and comply with the research procedures.

Exclusion criteria

1. Have a history of malignant colorectal tumor or have metastatic or multiple carcinoma.
2. Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, etc. who need emergency surgery.
3. Patients who need to undergo combined organ resection or robot-assisted colectomy.
4. Patients who are receiving preoperative neoadjuvant therapy.
5. ASA grade ≥ IV and/or ECOG performance status score \> 2.
6. Cardiopulmonary dysfunction (NYHA cardiac function classification II-IV), liver dysfunction (MELD score greater than 12), or kidney dysfunction (serum creatinine above the upper limit of normal);
7. Patients with severe psychiatric illness.
8. Pregnant or lactating women.
9. Patients who have a history of taking hormonal drugs.
10. Diabetic patients whose blood sugar cannot be controlled to be within 6.1 - 8.3 mmol/L.
11. Patients with other clinical and laboratory conditions that are considered by researchers as inappropriate for participating in this trial.

Exit criteria

1. Patients with other non-tumor diseases that prevent them from continuing to receive this treatment regimen.
2. Patients who need emergency surgical resection due to intestinal obstruction, intestinal perforation, intestinal bleeding, etc. after being enrolled in the study.
3. Patients with distant metastasis confirmed by intraoperative exploration or postoperative pathology, including liver, pelvic cavity, ovary, peritoneum, distant lymph node metastasis, etc.
4. Patients who need combined organ resection as determined by intraoperative exploration.
5. Patients who request to withdraw from this study cohort for various reasons after being enrolled in the study, or who cannot complete the study plan and follow-up for various reasons.
What Works to Get the Elderly Vaccinated Against COVID-19? Experimental Evidence From India

COVID-19 poses a substantial risk to elderly populations; understanding how to get elders vaccinated against the virus is therefore a policy priority. An experiment with elders in Tamil Nadu, India will be used to evaluate interventions policymakers might use to raise vaccination rates amongst the elderly. The particular interventions being tested are: calling elders to inform them about vaccination; encouragement of a "buddy system," whereby elders are accompanied to the vaccination site by another adult who could also get the vaccine; and seeding vaccination information with "gossips," individuals who elders identify as being good at spreading information in the elders' communities. The interventions are phone-based, and can be implemented quickly and at low cost. This makes them promising strategies the Tamil Nadu government and other governments could use to vaccinate elderly populations against COVID-19.


Eligibility Criteria:
Inclusion Criteria:

* At least 55 years of age
* Has phone number

Exclusion Criteria:

- Not part of the experiments registered under protocol IDs 223749 or 172020
Long-term Safety of Lumacaftor/Ivacaftor in Participants With Cystic Fibrosis Who Are Homozygous for F508del and 12 to <24 Months of Age at Treatment Initiation

This is a Phase 3, multicenter, open-label and roll-over study in participants who are 12 to \<24 months of age at initiation of Lumacaftor/Ivacaftor (LUM/IVA) treatment.


Eligibility Criteria:
Key Inclusion Criteria:

* Participants From Study VX16-809-122 Part B (Study 122)

  * Completed the 24-week Treatment Period and the Safety Follow-up Visit in Study 122B
* Participants Not From Study 122

  * Subjects will be 1 to less than 2 years of age
  * Homozygous for the F508del mutation (F/F)

Key Exclusion Criteria:

* Any clinically significant laboratory abnormalities that would interfere with the study assessments or pose an undue risk for the subject
* Solid organ or hematological transplantation

Other protocol defined Inclusion/Exclusion criteria may apply.
SMART TRENDS Study

A multicenter, interventional, feasibility comparison with historical controls


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Age ≥ 18 years
* ASA Physical Status ≥ 2
* Elective noncardiac surgery with expected surgery duration ≥ 3 hours and expected post-operative length of stay of ≥ 3 days
* Planned monitoring with an arterial catheter; Cohort 2: without planned arterial catheter insertion
* General anesthesia with tracheal intubation and positive pressure ventilation

Exclusion Criteria:

* Inability to comply with the study intra-operative hemodynamic management algorithm such as surgeon request for relative hypotension or fluid restriction or avoidance of vasopressors
* Planned vasopressor or inotrope infusion during surgery
* Contraindication to intra-arterial blood pressure monitoring
* Has previously participated in the SMART TRENDS study
* Serum creatine \> 2.0 mg/dL (\> 175 μmol/L) or CKD stage \> 3A
* Scheduled for intracranial or cardiac surgery
* Patient who is known to be pregnant
* Patients on mechanical circulatory support
* Emergency surgery
* Planned beach-chair positioning

Additional Exclusion Criteria for Cohort 2 only:

* Extreme contraction of the smooth muscle in the arteries and arterioles of the lower arm and hand, such as may be present in patients with Raynaud's disease
* Finger or hand deformity that prevents proper placement of finger cuff by visual inspection
* Inability to place Acumen IQ finger cuffs due to subject anatomy, condition, or obstructive paraphernalia (such as false nails)