cyrilzakka/clinical-trials huggingface dataset:
Measurement of the Fetal Occiput-spine Angle During the First Stage of Labor as Predictor of the Outcome of Labor

2D trans abdominal ultrasound was done during the first stage of labor. If fetal position is occiput anterior and fetal presentation is vertex, two dimensional sagittal picture of the fetal head and upper spine was acquired and stored in the ultrasound machine. On this image, the offline measurement of the angle formed by a line tangential to the occipital bone and a line tangential to the first vertebral body of the cervical spine (occiput-spine angle) will be performed to quantify the degree of fetal head flexion in respect to the trunk

2D trans abdominal ultrasound was done during the first stage of labor. If fetal position is occiput anterior and fetal presentation is vertex, two dimensional sagittal picture of the fetal head and upper spine was acquired and stored in the ultrasound machine. On this image, the offline measurement of the angle formed by a line tangential to the occipital bone and a line tangential to the first vertebral body of the cervical spine (occiput-spine angle) will be performed to quantify the degree of fetal head flexion in respect to the trunk.

The sonographer was not involved in the patient's care and the managing obstetrician was blinded to the ultrasound findings and the occiput-spine angle. For each patient of the study group, the progress of labor using a partogram ( cervical dilation ,effacement ,consistency, position and station ) and the mode of delivery were assessed retrospectively.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 \& 35 years old.
2. BMI is less than 30
3. The gestational age between 37- 42 weeks. (calculated by LMP or 1st trimesteric U/S)
4. Singleton pregnancy.
5. History of one vaginal delivery.
6. Occiputo anterior position.
7. Active phase of first stage of labor.

Exclusion Criteria:

1. Age (below18 or above 35).
2. Primigravida.
3. Occiputo posterior position.
4. Indications of cesarean section like malpresentations , macrosomia , placenta previa, previous cesarean section .
5. Multiple gestation.
6. Medical disorders like hypertension, DM, liver or renal diseases
RCT on the Combined Modality Treatment of Squamous Cell Carcinoma of the Esophagus

The purpose of the study was to test a null hypothesis that a combined modality treatment of esophageal cancer with neoadjuvant chemotherapy or chemoradiotherapy is equivalent to surgery alone and what are the benefits from adding irradiation to chemotherapy in neoadjuvant treatment of esophageal cancer.

The choice of the most beneficial method of treatment in esophageal cancer remains controversial and is the subject of vigorous debate. Surgery is still regarded as the principle modality among treatment strategies, with longterm survival achieved mainly in less advanced cases. More advanced cases, diagnosed more frequently, are more problematic in selection of the optimal therapeutic method. One of the options for improving treatment outcome in patients with advanced esophageal cancer is combined modality treatment with chemo- and chemoradiotherapy. Currently available RCTs have tested preoperative chemotherapy or chemoradiotherapy separately in comparison to surgery alone. Moreover, we do not know from these trials what is the added value of irradiation in a combined modality therapy over a preoperative chemotherapy. Another drawback of available RCTs is combining 2 different biological cancer entities: adenocarcinoma and squamous cell carcinoma of the esophagus as well as carcinoma of the esophagus and gastro-esophageal junction. That were the reasons for designing our trial testing 3 principal modes of esophageal cancer therapy: surgery vs. chemotherapy + surgery vs. chemoradiotherapy + surgery on homogenous population of esophageal cancer patients with single pathological type - squamous cell carcinoma affecting thoracic esophagus.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Histopathologically proven, clinically stage II-III (cTNM according to AJCC/UICC classification), primary squamous cell carcinoma of the thoracic esophagus
* Patients' age above 18 years
* General condition with Karnofsky performance status of \>70
* Circulatory and pulmonary capacity at normal range (FEV1 \>60%; FVC \>60%, NYHA I-II, cardiac output \>40%)
* Normal function of the bone marrow (RBC \>3,5 T/l; PLT \>100 G/l)
* Normal renal (creatinine \<1.5 of the upper limit) and liver (AST or ALT \<2,5 of the upper limit or bilirubin \<1,5 of the upper limit) function

Exclusion Criteria:

* Metastatic disease
* Synchronous malignancy
* History of other cancer within 5 years prior to esophageal cancer treatment
* History of allergic reaction to cisplatin of 5-fluorouracil
* Systemic infection
* Pregnancy or female patients in childbearing age without proper contraceptives.
The Effect of Food Taste, Temperature, and Viscosity on Swallowing Efficiency

The purpose of this study is to evaluate the effect of taste on swallowing efficiency, to evaluate the effect of temperature on swallowing efficiency, and to evaluate the effect of viscosity on swallowing efficiency.

Swallowing problems (dysphagia) are encountered frequently in primary practice and in the hospital setting. The list of possible causes is large, ranging from strokes and neurological disease to complications of cancer treatment, acid reflux, and surgery. Many patients have a reduced ability to feel food and fluid (reduced sensation) within the throat (pharynx) and this leads to an inability to manipulate food and fluids in the correct manner. This can produce a variety of swallowing problems such as choking on foods and fluids, regurgitation, aspiration, weight loss, malnutrition and poor quality of life.

Treatment of dysphagia is largely directed at rehabilitation of muscle power and education about safe swallowing techniques or positioning that limits food and fluid from entering the airway. One of the most widely accepted treatments of dysphagia is to alter the texture of food. Most patients with dysphagia will have more difficulty swallowing thin liquids. By adding a thickener to the liquid, a food bolus becomes more cohesive, and is less likely to become aspirated. Various types of thickening products are available over-the-counter without a prescription. These thickening products are bland and currently have no flavor. We hypothesize that alterations in food taste (sweet, salty, etc...), viscosity, and temperature, will improve swallowing efficiency. The purpose of this investigation is to evaluate the effects of food taste, texture, and temperature on swallowing efficiency. The goal is to develop safer, better tasting food products and improve the quality of life in patients with disabling swallowing disorders.

Eligibility Criteria:
Inclusion Criteria:

* Normal Volunteers:

  * Older than 55 years of age
  * No history of voice, swallowing, reflux, or progressive neurologic disease affecting the swallowing mechanism.
  * A normal self-administered dysphagia questionnaire (EAT-10 score of less than three)
* Patients with Dysphagia

  * Older than 55 years of age
  * Patients with the following condition: Dysphagia, globus, gastroesophageal reflux, or any other condition requiring referral for a dynamic swallowing study.
  * Patients willing to provide written informed consent for their participation in the study.

Exclusion Criteria:

1. Patients unable to complete the administration of the full taste and viscosity protocol.
2. Patients with profound dysphagia unable to safely consume the test solutions.
3. Patients with known sensitivities or allergies to any of the test solutions.
4. Patients who are prisoners.
5. Patients have a history of diabetes.
6. Patients who are unable to follow the simple instructions to swallow the test solutions on instruction and answer the questionnaire.
Correlation Between 3 Phase Bone Scintigraphy and Pressure Pain Thresholds in Patients With Complex Regional Pain Syndrome (CRPS)

The aim of the study is to investigate the correlation between increased bone metabolism in the 3 phase bone scintigraphy (TPBS) and decreased pressure pain thresholds in patients with complex regional pain syndrome (CRPS) of the upper limb and a non-CRPS-group. The investigators assume that there will be a significant correlation between the investigated values in the CRPS-group whereas the non-CRPS-group shows no significant correlation.

Pressure pain of the distal hand joints is a predominant symptom of CRPS. But so far, the diagnostic value of pressure pain in the diagnosis of CRPS has not been investigated. We compared the pressure pain thresholds of the carpus, metacarpophalangeal and proximal interphalangeal joints to a region of interest-based (ROI) analysis of a TBPS in patients with CRPS and patients with limb pain of other origin (non-CRPS-group).Additionally, the PPTs were established for a healthy control group to get reference data.

Eligibility Criteria:
Inclusion Criteria:

every participant:

* aged \> 18 years with written informed consent
* adequate understanding of the german language
* indication for a TPBS independent of the study

Patients with CRPS:

* patients with CRPS type 1 of the upper limb diagnosed on the basis of the budapest criteria (Harden, Bruehl et al., 2010)
* unilateral pain

Control group:

* patients with pain of the upper limbs of other origin than CRPS who underwent a TPBS
* unilateral pain

Healthy subjects:

* checked by the DFNS IMI questionnaire

Exclusion Criteria:

* missing informed consent
* inadequate understanding of the german language
* disease duration of more than 12 months
* other disease of the upper extremity (e.g. polyarthrosis, rheumatoid arthritis)
* pregnancy/ lactation period
Effects of Androgen Administration on Inflammation in Normal Women

The hypothesis of this study is that DHEA administration to increase male hormone in healthy normal-weight young women to levels present in women with Polycystic Ovary Syndrome will cause an inflammatory response in white blood cells in the fasting state, and in response to glucose ingestion.


Eligibility Criteria:
Inclusion Criteria:

* Acceptable health based on interview, medical history, physical examination and lab tests
* Ability to comply with requirements of the study
* Ability and willingness to provide signed, witnessed informed consent
* Between the ages of 18-40 years
* Body mass index between 18 and 25
* Normal regular monthly periods
* No clinical evidence of androgen excess
* No evidence of polycystic ovaries on ultrasound

Exclusion Criteria:

* Diabetes mellitus
* Clinically significant pulmonary, cardiac, renal, hepatic, neurologic, psychiatric, infectious and malignant disease
* High blood pressure
* Current or recent (within 30 days prior to study entry) use of any drugs known or suspected to affect reproductive function including oral contraceptives, metformin, gonadotropin releasing hormone agonists, or anti-androgens (spironolactone, flutamide, etc.)
* Use of medications that have an adverse drug interaction with DHEA therapy including antipsychotics, phenothiazines, lithium, selective serotonin reuptake inhibitors, triazolam, estrogen or testosterone formulations
* Known hypersensitivity to DHEA
* Two first-degree relatives with breast cancer or ovarian cancer
* Documented or suspected history of recent (within 1 year) illicit drug abuse or alcoholism
* Tobacco smoking
* Ingestion of any investigational drugs within 4 weeks prior to study onset
* Pregnancy or lactation (less than or equal to 6 weeks postpartum)
Efficacy and Safety of Idelalisib (GS-1101) in Combination With Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas

The primary objective of this study is to evaluate the effect of the addition of idelalisib to rituximab on progression-free survival (PFS) in adults with previously treated indolent non-Hodgkin lymphoma (iNHL).

An increased rate of deaths and serious adverse events (SAEs) among participants with front-line chronic lymphocytic leukemia (CLL) and early-line iNHL treated with idelalisib in combination with standard therapies was observed by the independent data monitoring committee (DMC) during regular review of 3 Gilead Phase 3 studies. Gilead reviewed the unblinded data and terminated this study in agreement with the DMC recommendation and in consultation with the US Food and Drug Administration (FDA).


Eligibility Criteria:
Key Inclusion Criteria:

* Histologically confirmed diagnosis of B-cell iNHL, with histological subtype limited to the following:

  1. Follicular lymphoma (FL) Grade 1, 2, or 3a
  2. Small lymphocytic lymphoma (SLL) with absolute lymphocyte count \< 5 x 10\^9/L at the time of diagnosis
  3. Lymphoplasmacytoid lymphoma/Waldenström macroglobulinemia (LPL/WM)
  4. Marginal zone lymphoma (MZL) (splenic, nodal, or extra-nodal)

Key Exclusion Criteria:

* History of lymphoid malignancy other than those allowed per inclusion criteria
* Ongoing drug-induced liver injury, active hepatitis C, active hepatitis B , alcoholic liver disease, non-alcoholic steatohepatitis, primary biliary cirrhosis, extrahepatic obstruction caused by cholelithiasis, cirrhosis of the liver, or portal hypertension.
* Received previous treatment with rituximab that was not effective.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Pharmacotherapy & CM for Opioid and Cocaine Dependence

The purpose of this study is to compare the efficacy of the combined treatment modafinil + Contingency Management (CM) to either treatment condition alone or to yoked-controls on cocaine abstinence.

To investigate the role of modafinil-related improvements in memory, impulse control, and attention in mediating cocaine abstinence.

We hypothesize that the treatment group receiving the combination of modafinil + Contingency Management will have significantly lower cocaine use than the other treatment conditions. We also hypothesize that improvements in memory, impulse control, and attention will be a significant contributor to the treatment improvements investigated in Specific Aim #1.

Opioid and cocaine dependence are major problems among veteran and non-veterans and no effective pharmacotherapy exists for cocaine dependence. Methadone has not shown robust effectiveness in reducing cocaine abuse. Thus, new treatments are needed for the individuals who have developed cocaine dependence. This study is designed to test a new pharmacotherapy for cocaine dependence and is a placebo-controlled trial.

Eligibility Criteria:
Inclusion Criteria:

* Male and female opioid-dependent patients between the ages of 18-65 will be entered into the study. Females must not be pregnant as determined by pregnancy screening, nor breast feeding, and must be using acceptable birth control methods during study participation.
* Current opioid dependence as evidenced by documentation of prior treatment for opioid dependence or signs of withdrawal, self-reported history of opioid dependence for consecutive 12 month period and a positive urine for opiates.
* Subjects must fulfill DSM-IV criteria for opioid and cocaine dependence.
* Subjects must have a history of cocaine use, with a reported street cocaine use of a minimum of 1/2 gram during the preceding 30 days. Additionally, laboratory confirmation of recent cocaine use (positive urine for cocaine) within 2 weeks prior to admission to the study is required.
* Subjects must be treatment-seekers for opioid and cocaine use.

Exclusion criteria:

* Current DSM-IV diagnosis of other drug or alcohol dependence (other than opiates, cocaine, or tobacco)
* History of heart disease, left ventricular hypertrophy, ischemic ECG changes, chest pain, arrhythmia, hypertension.
* History of severe renal, endocrine or hepatic diseases.
* History of psychosis, schizophrenia, or bipolar type I.
* History of seizure disorder.
* Current use of over-the-counter or prescription psychoactive drugs (antidepressant, anxiolytics, antipsychotics, mood stabilizers, psychostimulants).
* Liver function tests (SGOT,SGPT) greater than 3 times normal.
* Current use of modafinil
* Current suicidality
* Pregnancy or breast-feeding;
* Medical contraindication to treatment with study medication (e.g. for modafinil, history of heart disease, ischemic ECG changes, arrhythmia, hypertension).
* Women of child-bearing potential must agree to use other means of birth control and to have a pregnancy test repeated at least once monthly.
* Known allergy to modafinil or methadone.
Early Multimodal Neuromonitoring For Spontaneous Intracerebral Hemorrhage (ICH)

The investigators intend to assess the predictive value of early (first 48 hours) multimodal neuromonitoring parameters concerning late survival in critically ill intracerebral hemorrhage (ICH) patients.

Retrospective observational study based on analyzing the first 48 hours of the multimodal neuromonitoring signal, from spontaneous ICH patients, whose treatment includes invasive intraparenchymal neuromonitoring, treated from January 2015 to September 2021 in a tertiary hospital.

Eligibility Criteria:
Inclusion Criteria:

* Spontaneous Intracerebral Hemorrhage
* ICU admission
* Need of Sedation and Ventilatory Support
* Need of Intracerebral Neuromonitoring

Exclusion Criteria:

* Etiology for Intracerebral hemorrhage such as tumor, vascular malformation, ischemic transformation.
An Integrated Care Platform Based on the Monitoring of Older Individual Intrinsic Capacity for Inclusive Health (CAREUP)

The objective of this study is to assess the usability and acceptance of the CAREUP solution in improving the quality of life at home of the older adults. The CAREUP solution is a platform that collects data from different tools such as tablets, smartwatches, ambient sensors, iHealth weight scale, and Digital Hand Dynamometer.

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The objective of this study is to assess the usability and acceptance of the CAREUP solution at home in primary (older adults), secondary (informal caregivers) and tertiary (doctors and geriatrics) end users. The CAREUP solution is a platform that collects data from different tools such as tablets, smartwatches, ambient sensors, iHealth weight scale, and Digital Hand Dynamometer. The study will comprehends two phases: a pre-pilot and pilot phases.The pre-pilot phase will test new user interfaces and games with 5 older adult (primary users) and 5 informal caregiver (secondary) in each site (Italy, Romania, Austria) for at least 1 week. This phase will only focus on primary endpoints (usability and acceptance). The pilot phase will investigate platform usability, acceptance and efficiency of developed Intrinsic Capacity (IC) evaluation algorithms, reliability and security. At least 30 primary and 15 secondary and some tertiary users (doctors and geriatrics) will be enrolled in each country (Italy, Romania, Austria) for 12 months. This phase will focus on both primary and secondary endpoints.

Eligibility Criteria:
Inclusion Criteria:

* Live independently in their home in rural or urban areas;
* In good physical and cognitive status;
* Able to stand and walk unaided;
* Availability to sign the Informed Consent;
* Ability to use smartphones/tablets independently.

Exclusion Criteria:

* Use of active implant or not-implant medical devices;
* Allergy to nickel components;
* Lack of written informed consent;
* Acute or untreated medical problems such as history of syncopal episodes, epilepsy and vertigo not controlled pharmacologically; serious dysfunction of the autonomic system; severe behavioural syndromes not compensated by drugs; concurrent neurological diseases; severe systemic diseases with life expectancy \< 1 year;
* A myocardial infarction or stroke within 6 months;
* Painful arthritis, spinal stenosis, amputation, painful foot lesions or neuropathy limiting balance and mobility;
* Uncontrolled hypertension;
* Pacemaker or implantable cardioverter defibrillator;
* Diagnosis of mild and or/advanced Parkinson's disease or other neuromuscular disorder;
* Diagnosis of mild and/or advance cognitive impairments
* Metastatic cancer or immunosuppressive therapy;
* Significant visual or hearing impairment
Oral Selenium Therapy for the Prevention of Mucositis

Selenium as an antioxidant and anti-inflammatory agent could be effective in prevention of mucositis induced by chemotherapy and radiotherapy. Other agents such as vitamin E, Zinc sulfate, amifostine, beta carotene and benzidamine are indicated for prevention of mucositis and positive effects are seen. Our purpose in this double blinded randomized study is to evaluate the selenium effect on mucositis prevention in patient with acute myeloid leukemia (AML) \& acute lymphoblastic leukemia (ALL) whose received Busulfan and/or Cyclophosphamide before Hematopoietic stem cell transplantation (HSCT).

Patients with AML or ALL diagnosis, candidates for high dose chemotherapy with stem cell transplantation will be screened for enrollment in the study.

Patients will be randomized in two groups with balanced block randomization method. One group will receive selenium tablet twice per day and another group will receive placebo two times per day.Therapy will start on the morning before starting chemotherapy and will continue until the first of either discharge day or day +21.

Response assessment will include:

1. Mucositis assessment using WHO grading and OMAS scores- to be done from baseline and until day +21 or discharge day if before day +21.
2. Evaluation of selenium and glutathione peroxidase levels in the serum, - to be done at baseline, day +7 and day +14.
3. Collection of clinical outcome data regarding infectious complications including- presence and length of febrile neutropenia, use of antibacterial and antifungal medications

Eligibility Criteria:
Inclusion Criteria:

* Patients with AML or ALL undergoing high dose chemotherapy with stem cell transplantation
* Adequate renal and hepatic function

Exclusion Criteria:

* Taking selenium supplement before admission