cyrilzakka/clinical-trials huggingface dataset:
Emotional Disclosure in HIV

The specific objective of this study are to examine whether or not a treatment aimed at emotional disclosure may have beneficial psychological, health and immune effects for HIV infected individuals. The goal of the current study is to test the efficacy of emotional disclosure through writing in patients with HIV infection. We will compare emotional disclosure through writing about traumatic experiences (experimental intervention) to a control intervention (writing about emotionally neutral topics). \[Note that HIV RNA viral load, CD4 T cells, urinary cortisol, health related dysfunction, psychological distress, and medication adherence are the 6 primary outcome variables.


Eligibility Criteria:
Inclusion Criteria

* 18-65 years of age inclusive
* At least 8 years of formal education
* Literate
* Fluent in English

All of the following three must apply:

* No active Category C HIV AIDS-defining symptoms
* CD4 T-lymphocyte count between 150-499
* Viral load \>1000

Exclusion Criteria

* Less than 8 years formal education
* Illiterate or non-English speaking
* Active systemic diseases that would interfere with participation
* Current alcohol or substance dependence
* Planned change in HIV medication in the next 6 months, or recent change in past 2 months
* Introduction of antidepressant medication within 30 days of study start
* Current psychological counseling, cognitive behavior therapy, support group or other psychological therapy, or plans to start any of the above
* Diagnosis of PTSD or major depression
* Unable to attend at least 4 treatment sessions
Evaluating the Cost Effectiveness of ISTDP: A Quasi Experimental Study

Objective: To evaluate whether or not cases treated with Intensive Short-term Dynamic Psychotherapy (ISTDP) facilitate healthcare cost reduction, whether any observed reduction is greater than that of a control group and whether any such gains would be maintained in follow up.

Design: A quasi-experimental design was employed in which pre and post healthcare cost and usage data were extracted for all ISTDP treated cases from 1999 to 2008 and compared to parallel measures of a control group of cases referred but never treated.

Importance: Psychiatric and psychological disorders result in excess health care service use and costs. Brief psychotherapy methods may be effective across a broad range of mental disorders and could therefore result in healthcare cost reduction.

Objective: To evaluate whether or not cases treated with Intensive Short-term Dynamic Psychotherapy (ISTDP) facilitate healthcare cost reduction, whether any observed reduction is greater than that of a control group and whether any such gains would be maintained in follow up.

Design: A quasi-experimental design was employed in which pre and post healthcare cost and usage data were extracted for all ISTDP treated cases from 1999 to 2008 and compared to parallel measures of a control group of cases referred but never treated.

Setting: Treatments were provided at an urban University based psychotherapy service.

Participants: All cases from the province of Nova Scotia treated within the research time frame were included. 890 patients were included with a very broad range of psychiatric disorders including anxiety, mood, somatoform, personality and psychotic disorders. 192 referred but never see cases served as non randomized controls.

Intervention(s): ISTDP is an emotionally focused form of brief psychotherapy which has supportive, cognitive, experiential and primarily psychodynamic elements. In this setting the average length of treatment was 7.3 sessions and cost an estimated $500 dollars per treatment course.

Eligibility Criteria:
Inclusion Criteria:

* All patients referred for ISTDP treatment

Exclusion Criteria:

* Patients not referred for ISTDP treatment
Validation of a Non-invasive Diagnostic Method for Sarcoidosis Using Exhaled Breath

Sarcoidosis is a chronic lung disease that is characterized by fatigue, shortness of breath, chest pain and reduced lung function. Suffering from these diseases has a very negative effect on the quality of life. When people are suspected of having sarcoidosis various markers in the blood are measured. Ultimate diagnosis, however, always requires invasive techniques such as bronchoscopy and lung biopsy. Consequently, there is an urgent need for a new diagnostic tool that is easy, quick and most of all non-invasive and thus friendly for the patient.

Such a new diagnostic tool might be found in examining the exhaled air of patients, which contains a complex mixture of so-called volatile organic compounds (VOCs) that are the result of damaging processes that occur in the lung. Determining the VOC profile in the breath can be used as a biomarker, or biological indicator, of those damaging processes. In other words, searching for unique VOC profiles in the breath of sarcoidosis patients might lead to the development of a diagnostic tool that only uses their exhaled breath.

The current study involves 25 sarcoidosis patients and 25 healthy volunteers. The aim of this study is find VOCs in exhaled air that can be used to diagnose sarcoidosis. In a previous study, sarcoidosis-specific VOCs were found, which we intend to validate using the current study.


Eligibility Criteria:
Inclusion Criteria:

* Patients with confirmed sarcoidosis

Exclusion Criteria:

* (ex-) smokers
* for healthy controls: controls with pulmonary disease excluded
Prevention of Radiation-induced Severe Oral Mucositis in Oral Cavity, Oropharynx, Hypopharynx, and Cavum Cancer

The purpose of this study is to evaluate the benefit of a mouthwash with a phytopharmaceutical preparation, Homeodent®, compared to a mouthwash solution containing sodium bicarbonate, for prevention of severe mucositis (grade ≥3, RTOG classification) in patients receiving irradiation for oral cavity, oropharynx, hypopharynx or cavum cancer.

This is a phase III, controlled, randomized, single blind study. The estimated inclusion period is approximately 24 months. The number of patients required in this monocentric study is 330 (165 per arm).

The standard treatment of oral cavity, oropharynx, hypopharynx, and cavum cancers is external radiotherapy. However, one of the associated toxicities is the occurrence of mucositis which can be a limiting factor in the treatment (dose reduction or treatment interruption can limit patient's survival), patient's quality of life decreases and severe complications can occur. The treatment of mucositis is mainly symptomatic; a randomized study has shown a benefit of a mouthwash with Benzydamine, a non steroidal anti-inflammatory drug, for patients receiving 50-Gy radiation. Another study with a lower number of patients has also shown a benefit of using a zinc sulfate solution. Boiron laboratories have developed a phytopharmaceutical preparation, Homeodent®, which has no secondary effects and which could prevent radiation-induced mucositis. This study will evaluate the efficiency of mouthwash with Homeodent® in a large randomized trial.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patient aged ≥ 18 years
* ECOG PS ≤ 2
* Patient with oral cavity and/or oropharynx and/or hypopharynx and/or cavum epidermoid carcinoma, whatever the stage
* Patient receiving a minimum radiation dose of 60 Gy
* Planned radiotherapy to at least 1/3 of the oral mucosa and/or oropharynx
* Mandatory affiliation with a health insurance system
* Signed, written informed consent

Exclusion Criteria:

* Previous irradiation to the oral mucosa and/or oropharynx
* Pre-existing mucositis
* Pregnant or lactating woman (negative serum or urinary pregnancy test for women with child-bearing potential)
* Patient included in another study including experimental radiotherapy possibly toxic to the mucosa
* difficult follow up of the patient
* patient deprived of civil rights
Surgical Management of Posterior Tibial Plateau Fractures

This protocol concerns an academic, multicentric, and prospective clinical trial. In this study the investigators will evaluate the recently approved WAVE-plate (7S Medical) for open reduction and internal fixation and buttressing of the posterior proximal tibial column via a posteromedial reversed L-shaped approach. The reversed L-shaped approach has been shown as a safe technique with adequate visualisation of the posterior tibial surface. The investigators will thoroughly evaluate all important clinical, radiological and functional variables. The functional outcome will be reported in patient reported outcome measures by means of the validated Knee injury and Osteoarthritis Outcome Score (KOOS).


Eligibility Criteria:
Inclusion Criteria:

* Tibial plateau fracture with involvement of posterior proximal tibial plateau (according to revised three-column classification), requiring osteosynthesis

Exclusion Criteria:

* Absent contact information
* living abroad and cannot participate in the follow-up visits
* non-functional leg prior to treatment/injury
* pathological fractures
* bilateral fractures
Norepinephrine Plus Dobutamine Versus Epinephrine Alone for the Management of Septic Shock

Catecholamines infusion is a major component of septic shock management. International guidelines recommend that norepinephrine should be preferred to epinephrine, though phase III trials are lacking. The present study aimed at comparing the efficacy and safety of norepinephrine plus dobutamine to that of epinephrine in adults with septic shock.

The french Conference on Consensus on catecholamines use in septic shock has underlined the importance of carrying out a clinical trial to clarify the use of epinephrine, norepinephrine and dobutamine in the management of multiple organ failure associated with severe sepsis. The main objective of the study was therefore to compare the effects of the combination of dobutamine and norepinephrine to those of epinephrine alone in patients with septic shock. In this purpose, patients were randomly assigned to receive either epinephrine or norepinephrine plus dobutamine and drugs were titrated to maintain blood pressure over 70 mmHg. Main outcome was 28-day mortality.

Eligibility Criteria:
Inclusion Criteria:

* Adults over 18 years
* Informed consent

Presenting from less than 7 days :

* One or more infectious site
* At least 2 of the following criteria: temperature \> 38°C or \< 36.5°C, respiratory rate \> 20 breaths per min or PaCO2 \< 32 mmHg or mechanical ventilation, heart rate \> 90 beats/min, white blood cell count \> 12,000/mm3 or \< 4,000/mm3
* At least 2 of the following criteria: PaO2/FiO2 ratio \<280 mmHg (if mechanical ventilation, urinary output of less than 0.5 mL/kg of body weight or \< 30 mL/h at least 1 hour, plasma lactate \> 2 mmol/L, platelet count \< 100,000 /mm3

And presenting from at least 24 hours:

* Systolic blood pressure \< 90 mmHg or mean blood pressure \< 70 mmHg (for at least 30 min);
* 1000 mL fluid replacement or pulmonary capillary wedge pressure \> 12 mmHg
* Dopamine infusion at 15 µg/kg/min for at least 1 hour, or epinephrine or norepinephrine in first intention

Exclusion Criteria:

* Pregnant woman
* Obstructive cardiomyopathy
* Acute coronary disease
* Non infectious shock
* Care limitation
* White blood cell count \< 500 /mm3
Efficacy and Safety of Neoadjuvant Sintilimab Plus FLOT Versus Sintilimab Plus SOX Phase II Clinical Trial for Patients With Locally Advanced Gastric Cancer

This study aims to investigate the efficacy and safety of Sintilimab combined with FOLT versus Sintilimab combined with SOX in patients with locally advanced gastric cancer. The research design is intended to observe the comparison of conversion therapy effects, disease-free survival, R0 resection rate, and safety evaluation between the two groups.


Eligibility Criteria:
Inclusion Criteria:

* 1. Age \>=18 years and \<100 years.
* 2. Diagnosed with locally advanced gastric cancer.
* 3. Eastern Cooperative Oncology Group ECOG PS score 0-1.
* 4. adoption of preoperative chemotherapy treatment and PD-1 antibody therapy.
* 5. deficient mismatch repair identified by pathological detection.

Exclusion Criteria:

* 1. Locally advanced unable to resect or metastatic tumors.
* 2. Patients with recurrence of residual gastric cancer
* 3. Patients refusing surgical resection after preoperative chemotherapy therapy.
* 4. Have received any anti-tumor therapy such as chemotherapy, radiotherapy, immunotherapy, etc., or have been more than 180 days since the last treatment.
* 5. Patients with confirmed allergy to the study drug and/or its excipients.
* 6. Severe malnutrition and active autoimmune diseases.
* 7. Pregnant or lactating women.
* 8. Patients with medical systemic diseases and psychiatric diseases that are not amenable to chemotherapy.
* 9. Patients with acute infections requiring antibiotic treatment.
* 10. Patients with acute infections requiring antibiotic treatment.
* 11. Patients who are concomitantly receiving other immunotherapy, corticosteroids, and other anticancer therapies during the trial.
* 12. Positive test result for hepatitis B or hepatitis C virus.
* 13. Untreated central nervous system metastatic peripheral neuropathy (\>grade 1).
* 14. History of malignancy within the past 5 years (with the exception of curative, localized cancer).
* 15. Patients who are not expected to achieve R0 resection.
* 16. Weight loss greater than or equal to 20% within 4 weeks before the first dose.
* 17. Patients with multiple factors affecting oral medication.
* 18. Vaccination within 4 weeks prior to the first dose of study drug.
* 19. Patients who have received immune checkpoint inhibitors and develop serious adverse reactions after treatment and need to be permanently disabled.
* 20. The investigator believes that the subject has other serious systemic diseases or other reasons and is not suitable for this clinical study.
Virtual Reality Rehabilitation for Patients With Anterior Cruciate Ligament Reconstruction

The purpose of this study is to ascertain whether 4 weeks of daily virtual-reality-based rehabilitation at home improves disability in the early stages of recovery from anterior cruciate ligament reconstruction surgery compared with standard care.

After being informed about the study and potential risks and benefits, patients giving written informed consent will be randomized to one of two groups in a 1:1 ratio. The treatment group will perform daily a 20-minute rehabilitation session in virtual reality, in which they will observe their virtual body performing a series of exercises they would otherwise be unable to perform in real life. Both groups will also undergo the standard rehabilitation protocol. The investigators will assess for differences between groups in self-reported disability, knee range of motion, and quadriceps strength at baseline, 4 weeks, 12 weeks and 9 months.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18-40 (either sex)
* Post-operative anterior cruciate ligament reconstruction (autograft), either bone-patellar tendon-bone graft or semitendinosus (hamstring) graft

Exclusion Criteria:

* Patients with significant cognitive deficit (MEC\<24).
* Patients with epilepsy or severe vision problems
* Pregnant patients
* Previous surgery on the reconstructed knee, excluding arthroscopy
* Previous anterior cruciate ligament reconstruction on either knee
* Sustained concurrent injury to the contralateral knee
* Concomitant collateral ligament and/or meniscal repair
* Presence of symptomatic tibiofemoral osteoarthritis
Enhanced Recovery After Bilateral Reduction Mammaplasty

This single-center, clinical trial is being conducted to determine whether non-narcotic pain regiments are as effective as narcotic-based regiments in reducing post-operative pain in patients undergoing breast reduction in the outpatient setting.

This is a non-blinded, non-inferiority, randomized control trial with the primary outcome of interest being overall pain, with secondary outcomes including adverse effects from pain medications, patient satisfaction with their pain regiment and with their surgery, and the impact of pain on their daily activities. This study is designed to follow one-hundred (100) qualified and consenting patients seeing the PI/surgeon (JMK) at his office at UT Southwestern for their initial operative consultation for macromastia. If patients meet eligibility criteria, they will be offered enrollment in the trial.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing bilateral breast reduction (reduction mammaplasty) with the PI in the outpatient setting
* Age 18 and older
* BMI less than 40, non-smokers.

Exclusion Criteria:

* age less than 18,
* BMI over 40,
* smokers,
* uncontrolled diabetes,
* American Society of Anesthesiologists (ASA) status scores 3 or higher
* patients with allergies to any of the medications in the ERAS or current practice regiments (gabapentin, celecoxib, ketorolac, ondansetron, or hydrocodone).
* History of narcotic or IV drug abuse
* History of chronic pain
* Hypersensitivity or allergy to any of these drugs: gabapentin, celecoxib, ketorolac, hydrocodone, ibuprofen or acetaminophen
* Current pregnancy or planning pregnancy in the next xx weeks/ months
* Contraindications to NSAID drugs (ketorolac, ibuprofen, celecoxib): coagulation disorder, active bleeding, severe renal impairment, hepatic impairment.
* Contraindications to gabapentin: caution for CrCl \<60, caution in elderly, caution if alcohol consumption
* Contraindications to acetaminophen: hepatic or renal impairment, chronic alcohol use
Analysis of Biopsies From the Upper Gastrointestinal Tract

Multicenter study to correlate histological findings in the upper gastrointestinal tract with endoscopic and clinical data.

Prospective multicenter study involving six clinical institutions (see collaborators) with recruitment of consecutive patients who undergo routine upper endoscopy for several (non-selected) reasons. The patients will have to fill out a questionnaire about their history of reflux symptoms, including questions regarding smoking and drinking habits. The treating physician will have to complete a clinical protocol which includes a questionnaire regarding the patient's drug history.

The endoscopic examination is done in a routine, yet standardized fashion. In particular, biopsy material will be taken from the stomach, the gastroesophageal junction and from the duodenum. The samples will be routinely sent to the participating institutes of pathology (see collaborators) and will be assessed by independent histopathologists with special expertise in gastrointestinal pathology.

Endoscopic findings are documented in a standardized clinical protocol. Likewise, the histopathological assessment of the samples is done following a standardized protocol following the WHO classification and the updated Sydney classification, as appropriate.

Eligibility Criteria:
Inclusion Criteria:

* none

Exclusion Criteria:

* Patients with abnormal anatomy at the gastroesophageal junction (e.g. post surgery)
STAR-LIFE Registry: STARflo Glaucoma Implant Clinical Experience Program

STARflo is a novel suprachoroidal Glaucoma Drainage Device (GDD), bleb-free, exhibiting anti-fibrotic properties. Release of this CE Marked implant has been limited to leading Glaucoma Centers in Europe.

This Clinical Experience Program is being initiated to expand the surgical and clinical practice knowledge about the use of STARflo for reducing intraocular pression (IOP) in patients suffering from open angle glaucoma in a real world population of patients.

This program is designed to be an international multicenter observational study.

Patient data may be collected retrospectively and/or prospectively for up to 5 years after surgery.

The aim of this program is to document the patient's benefit following implantation of the STARflo implant in a real-word patient population, to learn about surgical practices and to collect data to support future cost-effectiveness analysis.

Eligibility Criteria:
Inclusion criteria:

* Patients suffering from open angle glaucoma or some case of narrow angle glaucoma who have been implanted with STARflo implant from 2011
* Patients who have signed a Data Release form

Exclusion criteria:

* Patients who did not sign a Data Release form
Neuromuscular Blockade Comparison for GI-2 Recovery After Bowel Resection

The purpose of this research study is to see the outcome of Sugammadex versus Neostigmine with Glycopyrrolate in colorectal surgery as it relates to its effects on post-surgical time (in hours) to first bowel movement and tolerance for solid food (GI-2 recovery) following bowel resection surgery

Neuromuscular blocking agents are essential during surgical procedures to paralyze the body to avoid unnecessary movement during surgery. There are various medications, such as Sugammadex that are later used to reverse the effects of the neuromuscular blockade. The U.S. performs approximately 320,000 colectomies per year for benign and malignant conditions such as Ulcerative Colitis (UC). Bowel resection surgery removes a portion of small or large intestine. Currently, there is little available prospective outcomes data regarding the use of Sugammadex versus Neostigmine with Glycopyrrolate in colorectal surgery as it relates to its effects on post-surgical time (hour) to first bowel movement and tolerance for solid food (aka GI-2 recovery) following bowel resection surgery. The study team will be conducting a randomized triple-blind study (patient's assigned group is hidden from the patient, provider, and research team). Randomization is created by using an electronic randomizer. Upon consent, the patient's assignment (per the randomizer) will be submitted to the Investigational Drug Service (IDS) Pharmacy by a department employee with no direct patient interaction.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Laparoscopic bowel resection surgery under general anesthesia with nondepolarizing neuromuscular blockade with rocuronium or vecuronium, and requiring inpatient admission

Exclusion Criteria:

* Allergy to Rocuronium, Vecuronium, or Sugammadex
* Bowel resection surgery requiring an ostomy
* No severe valvulopathy, no systolic heart failure with reduced ejection fraction (HFrEF), no coronary artery disease with positive stress test for ischemic regional wall motion abnormality
* No autoimmune pulmonary disease, no severe pulmonary fibrosis, no severe pulmonary hypertension, no COPD with requirement of home oxygen, no pulmonary cancer of primary or metastatic origin
* Creatinine Clearance (CrCl) of less than 30
* Pregnancy
* Incapable of providing consent or understanding the research project
Biomechanical Changes in Women With Post-partum Pelvic Girdle Pain: An Observational Case-control Study

Research suggests that changes in pelvic alignment during the perinatal period are the primary cause of pelvic girdle pain (PGP), both perinatally and postnatally. Researchers also report an association between temporomandibular joint disorder (TMD) and changes in lumbopelvic alignment. There are, however, no reports investigating temporomandibular joint disorders or changes in biomechanical alignment among women with postpartum pelvic girdle pain.

Research suggests that changes in pelvic alignment during the perinatal period are the primary cause of pelvic girdle pain (PGP), both perinatally and postnatally. Researchers also report an association between temporomandibular joint disorder (TMD) and changes in lumbopelvic alignment. There are, however, no reports investigating temporomandibular joint disorders or changes in biomechanical alignment among women with postpartum pelvic girdle pain.

Eligibility Criteria:
Inclusion Criteria:

- The age of the participants will be ranged from 20 to 40 years. Their body mass index will be ranged from 20 to 25 kg/m2. They will have regular menstrual cycle. They will not receive any hormonal therapy or taking any regular drugs

Exclusion Criteria:

* Bone disease. Discogenic state with radiculopathy or not. Systemic disease of musculoskeletal system. Any sensory problems. Previous vertebral fractures. Major spinal structural abnormality. Major jaw abnormality. Any jaw orthotics or prosthesis. Missing teeth.